The Prodigy Choice Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, palm, upper-arm, calf or thigh. The Prodigy Choice Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Prodigy Choice Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Prodigy Choice Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Prodigy Choice Test Strips are for use with the Prodigy Choice Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, palm, upper-arm, calf or thigh.

Device Description

The Prodigy Choice Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

The Prodigy Choice Blood Glucose Monitoring System is marketed as a meter only with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The Prodigy Choice Blood Glucose Monitoring System is also marketed as a meter kit with a carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution. The Prodigy No Coding Test Strips utilize the enzyme glucose oxidase, which is derived from recombinant protein derived from the fungus Aspergillus niger.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Prodigy Choice Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative table format. It refers to compliance with ISO and NCCLS standards but doesn't detail the specific performance thresholds required by those standards, nor does it present the device's performance against them directly within the summary.

Here's a table based on the information that is available:

Acceptance Criteria (Implied by Standards)	Reported Device Performance
Compliance with ISO 15197	Tested and complies
Compliance with NCCLS EP9-A	Tested and complies
Compliance with NCCLS SP5-A	Tested and complies
Compliance with ISO 14971	Tested and complies
Label Comprehension	Tested with Human Factor Study and complies
Usability	Tested with Human Factor Study and complies

Note: Since specific numerical acceptance criteria and direct performance metrics are not provided in the 510(k) summary, this table relies on the general statement that the device "was tested to the required standards" and "complies." Detailed performance data would typically be found in the actual test reports submitted to the FDA, which are not part of this summary.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify the sample size for the test set used in the performance testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. For a blood glucose monitoring system, the "ground truth" would typically refer to a reference laboratory instrument's measurement of glucose in blood samples.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is typically relevant for interpretative devices (e.g., imaging AI). For a blood glucose meter, which provides a direct quantitative measurement, an MRMC study is generally not applicable or mentioned. The provided text does not indicate that such a study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a "Blood Glucose Monitoring System" which includes a meter and test strips. Its performance is inherently standalone in the sense that it provides a direct measurement without human interpretation of its output. The summary does describe "Performance Testing" to required standards, which implicitly refers to the standalone performance of the system.

7. The Type of Ground Truth Used

For a blood glucose monitoring system, the ground truth is typically established by laboratory reference methods for glucose measurement, which are considered highly accurate and precise. While not explicitly stated in the summary, this is the standard practice for validating such devices. The summary implicitly refers to this by mentioning compliance with standards like ISO 15197 and NCCLS EP9-A, which define acceptable accuracy against reference methods.

8. The Sample Size for the Training Set

For a blood glucose meter, there isn't typically a "training set" in the sense of a machine learning algorithm being trained on a dataset. The device uses an "electrochemical method-based meter and dry reagent biosensor" which operates on established chemical principles, not machine learning. Therefore, a training set is not applicable or mentioned.

9. How the Ground Truth for the Training Set Was Established

As explained above, a "training set" is not applicable for this type of device.

Summary

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K122340

510(k) Summary 807.92(c)

SPONSOR	807.92(a)(1)
Company Name:	Prodigy Diabetes LLC
Company Address:	9300 Harris Corners ParkwaySuite 450Charlotte, NC 28269
Telephone:	704-285-6400
Fax:	704-285-6475
Contact Person:	Rick Admani
NOV 2 6 2013

Summary Preparation Date: October 24, 2013

DEVICE NAME	807.92(a)(2)
Trade Name:	Prodigy® Choice Blood Glucose Monitoring System
Common/Usual Name:	Blood Glucose Meter
Classification Name:	System, Test, Blood Glucose, Over the Counter
Regulation Number:	862.1345
Product Code:	NBW, CGA
Device Class:	II
Panel:	Clinical Chemistry

PREDICATE DEVICE

807.92(a)(3)

807.92(a)(4)

Legally Marketed Equivalent Device
Company	Product	510(k) #
Diagnostic Devices, Inc.	Prodigy Voice BGMS	K073118

DEVICE DESCRIPTION

The Prodigy Choice Blood Glucose Monitoring System consists of a meter and test strips. The

system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

।

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carrying case, battery, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution. The Prodigy No Coding Test Strips utilize the enzyme glucose oxidase, which is derived from recombinant protein derived from the fungus Aspergillus niger.

DEVICE INTENDED USE

807.92(a)(5)

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

Prodigy Choice Blood Glucose Monitoring System has equivalent technological characteristics and intended use as the Prodigy Voice Blood Glucose Monitoring System (K073118). The Choice Blood Glucose Monitoring System does not have the Voice capability.

PERFORMANCE TESTING

807.92(b)

Prodigy Choice Blood Glucose Monitoring System was tested to the required standards for blood glucose monitoring systems including:

ISO 15197 NCCLS EP9-A NCCLS SP5-A ISO 14971

Prodigy Choices Blood Glucose Monitoring System was also tested for label comprehension and usability with a Human Factor Study.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-6609 Silver Spring, MD 20993-0002

November 26, 2013

PRODIGY DIABETES CARE. LLC c/o E.J. SMITH SMITH ASSOCIATES 1468 HARWELL AVENUE CROFTON MD 21114

Re: K122340

Trade/Device Name: Prodigy Choice Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: 11 Product Code: NBW. CGA Dated: October 21. 2013 Received: October 21, 2013

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2- E.J. Smith

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
510(k) Number (if known)

510(K) Ki 22340

Device Name

Prodigy Choice Blood Ghucose Monitoring System

Indications for Use (Describe)

The Prodigy Choice Blood Clucose Monitoring System is intended to be used for the quantialive measurement of glucose (sugar) in firsh capillary whole blood samples drawn from the lingertips, forearm, palm, call or thigh. The Prodity Choice Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Prodicy Choice Blood Olucose Monitoring System is include the body (In viro digense use) by people
with diabets al home as an ald to monitor the effectiveness of disbets System should not be used for the diagnosis of or secondal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Prodigy Choice Test Strips are for use with the Prodigy Choles Meter to quantitutively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, palm, upper-arm, calf or thigh.

Type of Use (Select one or both, es epplicable) | Prescription Uso (Parl 21 CFR 801 Subpart D)

[8] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Canter for Devices and Radiological Health (CORH) (Signature)

Stayce Beck

FORM FDA 3881 (9/13)

Page 1 of 2

FWA-Funding-Request-2024.doc

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.