PRODIGY CHOICE

K122340 · Prodigy Diabetes Care, LLC · NBW · Nov 26, 2013 · Clinical Chemistry

Device Facts

• Record ID: K122340
• Device Name: PRODIGY CHOICE
• Applicant: Prodigy Diabetes Care, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Prodigy Choice Blood Glucose Monitoring System measures glucose in capillary whole blood via amperometric assay using glucose oxidase (Aspergillus sp.). User applies 0.7 μL blood sample to test strip; meter measures electrical current proportional to glucose concentration. Used at home by patients with diabetes for monitoring; not for insulin dosing or CGM calibration. Meter features auto-coding; requires user to verify code on strip vial matches meter display. Results displayed on screen; used by patients to track glucose levels. System includes meter, test strips, control solution, and lancing device. Designed for single-patient use; validated for cleaning/disinfection cycles.

Clinical Evidence

Clinical performance evaluated via lay-user study (n=151) and healthcare professional (HCP) study (n=100). Accuracy compared against YSI reference method across finger, palm, forearm, upper-arm, calf, and thigh sites. Results showed 95% of readings within ±15 mg/dL for concentrations <75 mg/dL and within ±20% for concentrations ≥75 mg/dL. Bench testing included precision (pooled %CV 2.5-5.2%), linearity (r=1.00), interference testing, hematocrit (20-60%), altitude, and temperature/humidity stability.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme (Aspergillus niger); quantitative measurement of capillary whole blood; battery-powered; handheld meter form factor; no voice capability.

Indications for Use

Indicated for people with diabetes mellitus for quantitative measurement of glucose in fresh capillary whole blood from fingertips, palm, forearm, upper-arm, calf, or thigh. For home self-testing as an aid to monitor diabetes control. Contraindicated for neonatal use, screening or diagnosis of diabetes, critically ill patients, patients in shock, dehydrated patients, or hyper-osmolar patients.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Prodigy Voice BGMS (k073118)

Submission Summary (Full Text)

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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 Parkway<br>Suite 450<br>Charlotte, 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.

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

।

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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)

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.

#### 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.

20

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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 [phone] or [phone] 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 [phone] or [phone] 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 SERVICES<br>Food 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)

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