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  3. WX3-828

WX3-828Instant blood glucose meter

Roche Diabetes Care

Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Nov 26, 2025
Application Purpose
Original Equipment
Equipment Note
Instant blood glucose meter
Frequency Range
2404.00000000 - 2480.00000000
Company
Roche Diabetes Care
Country
United States

Documents & Files

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Attestation Statements

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Cover Letter(s)

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ID Label/Location Info

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RF Exposure Info

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Test Report

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Attestation Statements

TO: Federal Communication Commission Equipment Authorization Division Application Processing Branch 7435 Oakland Mills Rd Columbia, MD 21046 Date 03-Oct-2025 Pursuant to FCC 22-84 Report and Order and KDB 986446 D01 Covered Equipment v01, the Commission adopted new FCC requirements to protect the nation’s networks and supply chains from equipment that poses an unacceptable risk to national security or the safety of U.S. persons. Specifically, the Commission adopted rules that prohibit equipment authorization for “covered” telecommunications equipment and video surveillance equipment produced by entities identified on the Commission’s Covered List. Certifications FCC ID: WX3-828 concerning “covered” equipment. Section 2.911(d)(5)(i)-(ii). Roche Diabetes Care, Inc. (“the applicant”) certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Roche Diabetes Care, Inc. (“the applicant”) certifies that the equipment for which authorization is sought does not contain software listed on the “covered” list which is prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Roche Diabetes Care, Inc. certifies that as of the date of the filing of the application, the applicant is not identified on the covered list as an entity producing covered equipment. Thank you. Regards, Signature: Date: 03-Oct-2025 Signed by (printed name): David Chandler

Cover Letter(s)

TO: Federal Communication Commission Equipment Authorization Division Application Processing Branch 7435 Oakland Mills Rd Columbia, MD 21046 ATTENTION: Federal Communication Commission Equipment Authorization To whom it may concern, We would like to submit for Certification to FCC: WX3-828. Please find in the following application all related documentation to support this New Single Certification. We would appreciate your prompt attention to the submittal. Applicant Company name: Roche Diabetes Care, Inc. Contact Name: David Chandler Address: 9115 Hague Road, Indianapolis, IN, 46256 Telephone No: +1 (463) 239-1612 Fax No: Email: [email protected] FCC ID Number: WX3-828 Signature: Date: 03-Oct-2025 Signed by (printed name): David Chandler

Cover Letter(s)

. Request for Confidentiality Date: Oct 1, 2025 Subject: Confidentiality Request for: FCC ID: WX3-828 Accu-Chek Instant Pursuant to FCC 47 CFR 0.457(d) and 0.459, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit Short Term Permanent Block Diagrams Short Term External Photos Short Term Permanent Internal Photos Short Term Permanent Operation Description/Theory of Operation Short Term Permanent Parts List & Placement/BOM Short Term Permanent Tune-Up Procedure Short Term Permanent Schematics Short Term Test Setup Photos Short Term Permanent User’s Manual Roche Diabetes Care, Inc., has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality: The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. Applicant is also aware that they are responsible to notify ELITE ELECTRONIC ENGINEERING, INC. in the event information regarding the product or the product is made available to the public. ELITE ELECTRONIC ENGINEERING, INC. will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. Sincerely, By: ________Sr, Engineer____________ David Chandler__________ (Signature/Title) (Print name)

ID Label/Location Info

Exhibit A ID Label and Location Draft of new FCC number Photo of Molding Sample 828

RF Exposure Info

Engineering Test Report No. 2403093-02 Report Date September 8, 2025 Manufacturer Name Roche Diabetes Care Inc Manufacturer Address 9115 Hauge Rd Indianapolis, IN 46250 Product Name Model No. Accu-Check Instant Blood Glucose Meter 980mmol/L Date Received August 13, 2025 Assessment Dates August 18, 2025 – August 25, 2025 Specifications FCC 47 CFR Part 2.1093 KDB, 447498 D01 OET Bulletin 65:1997 RSS-102 EN 62311 EN 62479 AS/NZS 2772.2 RPS S-1 Test Facility Elite Electronic Engineering, Inc. 1516 Centre Circle, Downers Grove, IL 60515 Signature Tested by Nathaniel Bouchie Signature Approved by Raymond J. Klouda, Re gistered Professional Engineer of Illinois – 44894 PO Number 4170046184 This report is for your exclusive use. Any copying or replication of this report to or for any other person or entity, or use of our name or trademark, is permitted only with our prior written permission. This report sets forth our findings solely with respect to the test samples identified herein. The results set forth in this report are not indicative or representative of the quality or characteristics of the lot from which a test sample was taken or any similar or identical product unless specifically and expressly noted. Our report includes the results thereof based upon the information that you provided to us. You have 60 days from date of issuance of this report to notify us of any material error or omission caused by our negligence, provided, however, that such notice shall be in writing and shall specifically address the issue you wish to raise. A failure to raise such issue within the prescribed time shall constitute your unqualified acceptance of the completeness of this report, the tests conducted and the correctness of the report contents. This report shall not be reproduced, except in full, without the written approval of Elite Electronic Engineering Inc. Engineering Test Report No. 2403093-02 This report shall not be reproduced, except in full, without the written approval of Elite Electronic Engineering Inc. Page 2 of 24 Table of Contents 1. Report Revision History ........................................................................................................................... 3 2. Introduction .............................................................................................................................................. 4 3. Subject of Investigation ............................................................................................................................ 4 4. Standards and Requirements .................................................................................................................. 4 5. Sample Calculations ................................................................................................................................ 5 6. Photographs of EUT ................................................................................................................................ 6 7. Limits and Requirements ......................................................................................................................... 7 7.1. Requirements mandated by the FCC ...................................................................................................... 7 7.2. Requirements mandated by Innovation, Science and Economic Development Canada ........................ 9 7.3. Requirements mandated by the European Union and outlined in EN 62311 ........................................ 10 7.4. Requirements mandated by Australia/New Zealand and outlined in AS/NZS 2772.2 ........................... 11 8. Assessment Results .............................................................................................................................. 12 8.1. RF Exposure Evaluation Relevant to the Requirements of the FCC ..................................................... 12 8.2. RF Exposure Evaluation Relevant to the Requirements of the ISED .................................................... 12 8.3. RF Exposure Evaluation Relevant to the Requirements of the EU ....................................................... 13 8.4. RF Exposure Evaluation Relevant to the Requirements of Australia/New Zealand .............................. 13 9. Statement of Compliance ....................................................................................................................... 14 10. Scope of Accreditation ........................................................................................................................... 15 Engineering Test Report No. 2403093-02 Page 3 of 24 1. Report Revision History Revision Date Description – 9 SEP 2025 Initial Release of Engineering Test Report No. 2403093-02 Engineering Test Report No. 2403093-02 Page 4 of 24 2. Introduction The FCC, Innovation, Science and Economic Development Canada, European Union and Australia/New Zealand publish standards regarding the evaluation of the RF Exposure hazard of radio communications devices. An evaluation has been performed on the Roche Diabetes Care Inc Accu-Check Instant Blood Glucose Meter, Model No. 980mmol/L and 980mmol/L pursuant to the relevant requirements. 3. Subject of Investigation This document presents the demonstration of RF Exposure compliance on a Accu-Check Instant Blood Glucose Meter, (hereinafter referred to as the Equipment under Test (EUT)). The EUTs were identified as follows: EUT Identification Description Accu-Check Instant Blood Glucose Meter Model No. 980mmol/L S/N Conducted Sample – 98022584716 Radiated Sample –98022584718 Radio Access Technology BLE Bands of Operation 24000 – 2483.5MHz EIRP 2.2 dBm Conducted Output Power -1.92 dBm 4. Standards and Requirements The tests were performed to selected portions of, and in accordance with the following specifications. - 47 CFR Parts 1.1310, 2.1091 and 2.1093 Code of Federal Regulations, Title 47, Telecommunications - KDB 447498 D01 – “RF Exposure Procedures and Equipment Authoriza…

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Test Report

Engineering Test Report No. 2403093-01 Rev. B Report Date September 8, 2025 Manufacturer Name Roche Diabetes Care Inc Manufacturer Address 9115 Hauge Rd Indianapolis, IN 46250 Product Name Model No. Accu-Chek Instant Blood Glucose Meter – 980mmol/L Date Received August 13, 2025 Test Dates August 18, 2025 – August 25, 2025 Specifications FCC "Code of Federal Regulations" Title 47 Part 15, Subpart C, Section 15.247 Innovation, Science, and Economic Development Canada, RSS-247 Test Facility Elite Electronic Engineering, Inc. 1516 Centre Circle, Downers Grove, IL 60515 FCC Reg. Number: 269750 IC Reg. Number: 2987A CAB Identifier: US0107 Signature Tested by Nathaniel Bouchie Signature Approved by Raymond J. Klouda, Re gistered Professional Engineer of Illinois – 44894 PO Number 4170046184 This report is for your exclusive use. Any copying or replication of this report to or for any other person or entity, or use of our name or trademark, is permitted only with our prior written permission. This report sets forth our findings solely with respect to the test samples identified herein. The results set forth in this report are not indicative or representative of the quality or characteristics of the lot from which a test sample was taken or any similar or identical product unless specifically and expressly noted. Our report includes all of the tests requested by you and the results thereof based upon the information that you provided to us. You have 60 days from date of issuance of this report to notify us of any material error or omission caused by our negligence, provided, however, that such notice shall be in writing and shall specifically address the issue you wish to raise. A failure to raise such issue within the prescribed time shall constitute your unqualified acceptance of the completeness of this report, the tests conducted and the correctness of the report contents. This report shall not be reproduced, except in full, without the written approval of Elite Electronic Engineering Inc. Elite Electronic Engineering Incorporated certifies that the information contained in this report was obtained under conditions which meet or exceed those specified in the FCC "Code of Federal Regulations" Title 47 Part 15, Subpart C, Section 15.247 and Innovation, Science, and Economic Development Canada, RSS-247 test specifications. The data presented in this test report pertains to the EUT on the test dates specified. Any electrical or mechanical modifications made to the EUT subsequent to the specified test date will serve to invalidate the data and void this certification. This report must not be used to claim product certification, approval, or endorsement by A2LA, NIST, or any agency of the Federal Government. Engineering Test Report No. 2403093-01 Rev. B This report shall not be reproduced, except in full, without the written approval of Elite Electronic Engineering Inc. Page 2 of 60 Table of Contents 1. Report Revision History ........................................................................................................................... 3 2. Introduction .............................................................................................................................................. 4 2.1. Scope of Tests ......................................................................................................................................... 4 2.2. Purpose .................................................................................................................................................... 4 2.3. Identification of the EUT ........................................................................................................................... 4 3. Power Input .............................................................................................................................................. 4 4. Grounding ................................................................................................................................................ 4 5. Support Equipment .................................................................................................................................. 4 6. Interconnect Leads .................................................................................................................................. 5 7. Modifications Made to the EUT ................................................................................................................ 5 8. Modes of Operation ................................................................................................................................. 5 9. Test Specifications ................................................................................................................................... 5 10. Test Plan .................................................................................................................................................. 6 11. Deviation, Additions to, or Exclusions from Test Specifications .............................................................. 6 12. Laboratory Conditions .............................................................................................................................. 6 13. Summary .................................................................................................................................................. 6 14. Sample Calculations ................................................................................................................................ 6 15. Statement of Conformity .......................................................................................................................... 7 16. Certification .............................................................................................................................................. 7 17. Photographs of EUT ....................................................................…

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Test Report

Engineering Test Report No. 2403093-01 Rev. B Page 57 of 60 Engineering Test Report No. 2403093-01 Rev. B Page 58 of 60 Engineering Test Report No. 2403093-01 Rev. B Page 59 of 60 Engineering Test Report No. 2403093-01 Rev. B Page 60 of 60

Test Report

Over-the-Air (OTA) Test Report Engineering Test Report 2403093-06 Rev A Product Name Brand/Model No. Accu-Chek Instant Blood Glucose Meter 980mmol/L EUT Type Integrated Device Manufacturer Name Roche Diabetes Care Inc Manufacturer Address 9115 Hauge Rd Indianapolis, IN 46250 UNITED STATES Requested By Dave Chandler PO Number 4170046184 Test Dates 10/6/2025 Test Facility Elite Electronic Engineering, Inc. 1516 Centre Circle Downers Grove, IL 60515 Signature Tested by John Peters Senior Wireless Test En gineer Signature Approved by Raymond J. Klouda, Re gistered Professional Engineer of Illinois – 44894 This report is for your exclusive use. Any copying or replication of this report to or for any other person or entity, or use of our name or trademark, is permitted only with our prior written permission. This report sets forth our findings solely with respect to the test samples identified herein. The results set forth in this report are not indicative or representative of the quality or characteristics of the lot from which a test sample was taken or any similar or identical product unless specifically and expressly noted. Our report includes all of the tests requested by you and the results thereof based upon the information that you provided to us. You have 60 days from date of issuance of this report to notify us of any material error or omission caused by our negligence, provided, however, that such notice shall be in writing and shall specifically address the issue you wish to raise. A failure to raise such issue within the prescribed time shall constitute your unqualified acceptance of the completeness of this report, the tests conducted and the correctness of the report contents. This report shall not be reproduced, except in full, without the written approval of Elite Electronic Engineering Inc. Elite Electronic Engineering Incorporated certifies that the information contained in this report was obtained under conditions which meet or exceed those specified in the test specification(s). The data presented in this test report pertains to the EUTon the test date(s) specified. Any electrical or mechanical modifications made to the EUT subsequent to the specified test date will serve to invalidate the data and void this certification. This report must not be used to claim product certification, approval, or endorsement by A2LA, CTIA, or any other agency. Engineering Test Report No. 2403093-06 Rev A Page 2 of 16 1. REPORT REVISION HISTORY Revision Date Description - 9/23/2025 Initial Release of Engineering Test Report No. 2403093-06 A 10/16/2025 By John Peters - Throughout the report: Updated Report Number to 2403093-06 Rev A. - Cover Page: Updated the Test Date. - Section 3.1 - Evaluation Frequencies: Updated test frequencies. - Section 3.1 - Notes: Updated device programming notes. - Section 7.1: Updated the temperature and humidity. - Section 7.2: Updated the results table. - Section 8: Updated all plots. Engineering Test Report No. 2403093-06 Rev A Page 3 of 16 2. TABLE OF CONTENTS DESCRIPTION OF CONTENTS PAGE NO. 1. REPORT REVISION HISTORY ................................................................................................................... 2 2. TABLE OF CONTENTS ............................................................................................................................... 3 3. DESCRIPTION OF EQUIPMENT UNDER TEST (EUT) .............................................................................. 4 3.1. Product Description ............................................................................................................................. 4 3.2. EUT Photographs ................................................................................................................................ 5 4. LIST OF TEST EQUIPMENT: ...................................................................................................................... 9 5. MEASUREMENT UNCERTAINTY BUDGET: .............................................................................................. 9 6. TEST METHOD .......................................................................................................................................... 10 6.1. Radiated Test Setup (TRP) ............................................................................................................... 10 7. SUMMARY OF TEST RESULTS ............................................................................................................... 10 7.1. Environmental Conditions: ................................................................................................................. 10 7.2. Total Radiated Power (TRP) ............................................................................................................. 10 8. PLOTS ........................................................................................................................................................ 11 8.1. 3D TRP- Free Space ......................................................................................................................... 12 8.2. 2D TRP- Free Space ......................................................................................................................... 15 Engineering Test Report No. 2403093-06 Rev A Page 4 of 16 3. DESCRIPTION OF EQUIPMENT UNDER TEST (EUT) 3.1. Product Description Product Description Integrated Device Accu-Chek Guide Me Blood Glucose Meter 980mmol/L HW Version 0189-113 SW Version GenTest V3.5.6 EUT Dimensions 8 x 5 x 1.5 cm Primary Mechanical Mode Free-Space Serial Number 98022584718 Device Quantity 1 Antenna Type F-type PCB Trace Evaluation Frequencies 2404MHz, 2444MHz, 2480MHz Notes: The EUT was programmed using the customer’s laptop, a USB cable, GenTest software, and batch file using Windows Command Prompt. Commands: “1” to Turn on the BLE device “J” to Set max DTM power to 0dBm “G” to Turn on modulated signal at channel 0 “:” to Turn on…

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Test Report

Engineering Test Report No. 2403093-06 Rev A Page 12 of 16 8.1. 3D TRP- Free Space Roche Diabetes Care Inc Accu-Chek Instant Blood Glucose Meter 980mmol/L 2404MHz Engineering Test Report No. 2403093-06 Rev A Page 13 of 16 Roche Diabetes Care Inc Accu-Chek Instant Blood Glucose Meter 980mmol/L 2444MHz

Test Report

Engineering Test Report No. 2403093-06 Rev A Page 14 of 16 Roche Diabetes Care Inc Accu-Chek Instant Blood Glucose Meter 980mmol/L 2480MHz Engineering Test Report No. 2403093-06 Rev A Page 15 of 16 8.2. 2D TRP- Free Space XY_Plane XZ_Plane -8.3-6.2-4.2-2.10 0 30 60 90 120 150 180 210 240 270 300 330 2404MHz [dB]2444MHz [dB]2480MHz [dB] -8.4 -7 -5.6-2.8-0.1 1.3 2.7 0 30 60 90 120 150 180 210 240 270 300 330 2404MHz [dB]2444MHz [dB]2480MHz [dB] Engineering Test Report No. 2403093-06 Rev A Page 16 of 16 YZ_Plane End of Report -9.1-6.7-4.4-20.3 0 30 60 90 120 150 180 210 240 270 300 330 2404MHz [dB]2444MHz [dB]2480MHz [dB]

Contact Information

Applicant

Tony Heleine(Principal R&D Engineer)
[email protected]Fax: 3175213404

Technical Contact

Roche Diabetes CareTony Heleine
[email protected]

9115 Hague RD · Indianapolis, 46256 · United States

Test Firm

Elite Electronic Engineering Inc.Kevin Halpin
[email protected]Fax: 630-495-9785

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz640.00 µW
Confidentiality
Long Term
Grant Notes
Power Output is Conducted. The antenna(s) used for this transmitter must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Grantee must provide installation and operating instructions for complying with FCC multi-transmitter product procedures and RF Exposure compliance. This filing meets the SAR threshold exclusion set forth in KDB 447498 and therefore can be used in mobile/portable configurations.

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Equipment Class

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