The Prodigy Preferred 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, upper arm, palm, calf or thigh. The Prodigy Preferred Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Prodigy Preferred 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 Preferred 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 No Coding Test Strips are for use with the Prodigy Preferred Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh.

Device Description

The Prodigy Preferred Blood Glucose Monitoring System consists of a meter and Prodigy No Coding 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 Preferred 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 Preferred 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 utilizes the active enzyme is Glucose Oxidase, derived from Aspergillus niger.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Prodigy® Preferred Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For many of the tests, the acceptance criterion specifically states "met the acceptance criteria" or "less than X" while also reporting the actual performance as "less than X" or "within acceptance criteria," implying that the stated performance is the acceptance criterion itself, or that the performance achieved the desired threshold.

Test Category	Acceptance Criteria	Reported Device Performance
Precision Test	< 5.0 mg/dL for glucose < 75 mg/dL (pooled and maximum SD); < 5.0% for glucose ≥ 75 mg/dL (pooled and maximum CV); Maximum individual bias < 10% compared with YSI2300.	Pooled and maximum SD were < 5.0 mg/dL at glucose < 75 mg/dL; Pooled and maximum CV were < 5.0% at glucose ≥ 75 mg/dL; Maximum individual bias was < 10% compared with YSI2300.
Linearity	Correlation coefficient > 0.95; 100% of individual bias within ±10% between 20-600 mg/dL.	Correlation coefficient > 0.95; 100% of the bias of individual glucose results fell within ±10%. Linearity acceptable between 20-600 mg/dL.
System Accuracy	For blood glucose level < 75 mg/dL, 95% of results within ±15 mg/dL or 95% of results within ±20% for blood glucose level ≥ 75 mg/dL (ISO 15197 requirement).	>95% of all alternative site tested results fell within the acceptance criteria (15mg/dL for blood glucose <75 mg/dL and 20% for blood glucose ≥75mg/dL). Met ISO 15197 requirements.
Interference	No obvious interference (implied: bias compared to control pool within ~10%); No significant effect from specified normal/therapeutic concentrations of listed substances.	All bias of test results were ~ 10% compared with the measurements of the controlled pool. No obvious interference observed at therapeutic or physiological levels at three blood glucose levels. Specified substances (uric acid, ascorbic acid, acetaminophen, etc.) at normal/therapeutic concentrations did not significantly affect results.
Hematocrit	All individual difference < ±10% compared with individual YSI mean, for HCT 20-60%; All SD < 5mg/dL and all CV < 5%.	When HCT between 20% to 60%, all individual difference compared with individual YSI mean were < ±10%. All individual bias compared with YSI mean in HCT 40% was < ±10%. All SD were < 5mg/dL and all CV were < 5%. Accepted HCT range 20% to 60%.
Volume Verification	Sample volumes between 0.7 to 1.5uL fall within acceptable criteria. (Implied: accurate results)	Sample volumes between 0.7 to 1.5uL fell within acceptable criteria. (Required at least 0.7uL for accurate results).
Measurement Internal Determination Test (High Temp Exposure)	Glucose measurements with check strip before and after high temperature exposure < 2.0 mg/dL difference; Mean difference of before and after control solution measurements (Level N and H) < 5.0 mg/dL.	Glucose measurements with check strip before and after high temperature exposure < 0.2 mg/dL difference. Mean difference of before and after control solution measurements (Level N and H) < 3.6 mg/dL. (Performance exceeded acceptance criteria). The meters passed.
Altitude Study	Individual results fall within ± 10% from 91 to 3,402 meters altitude.	Individual results fell within ± 10% at altitude from 91 to 3,402 meters. No significant effects from 298 feet to 11,161 feet (91 to 3,402 meters).
Storage Condition (Test Strips)	All individual bias < ± 10%. (Implied: stability for 24 months unused, 90 days opened).	All individual bias < ± 10%. Unused test strips stable for 24 months and 90 days in used vials even after transportation.
Temperature for Equipment	Maximum individual bias < 10% compared with YSI 2300.	Maximum individual bias of meters treated to extreme temperature measurements < 10% by using venous whole blood.
Humidity Test for Equipment	Maximum individual bias < 10% compared with YSI 2300.	Maximum individual bias of meters treated to extreme humidity measurements < 10% by using venous whole blood.
Operating Condition (Test Strips)	Performance of individual bias < ± 10%.	Performance of individual bias of test strips evaluated in extreme environments < ± 10%.
Low Temperature Test	Glucose measurements with check strip before and after low temperature exposure < 2.0 mg/dL difference; Mean difference of before and after control solution measurements (Level N and H) < 5.0 mg/dL.	Glucose measurements with check strip before and after low temperature exposure < 0.2 mg/dL difference. Mean difference of before and after control solution measurements (Level N and H) < 3.9 mg/dL. (Performance exceeded acceptance criteria). The meters passed.
Humidity Detection Limit	All CV of test results < 4% for different humidity levels; Total CV of average values < 4% for "Normal" and "High" control solution (RH 10 ~ 85%).	All CV of test results < 4%. Total CV of average values < 4% for "Normal" and "High" control solution for RH 10 ~ 85%.
High Temperature Test	Glucose measurements with check strip before and after high temperature exposure < 2.0 mg/dL difference; Mean difference of before and after control solution measurements (Level N and H) < 5.0 mg/dL.	Glucose measurements with check strip before and after high temperature exposure < 0.2 mg/dL difference. Mean difference of before and after control solution measurements (Level N and H) < 3.6 mg/dL. (Performance exceeded acceptance criteria). The meters passed.
Temperature Test	All precisions of test results < 4%; Total CV of average values < 4% for "Normal" and "High" control solution (10 to 40°C).	All precisions of test results < 4%. Total CV of average values < 4% for "Normal" and "High" Prodigy control solution for 10 to 40°C. Passed operating (10~~40℃) and storage (4~~40℃) temperatures.
Robustness Test	Appearance, structure, and function of meters regular after cleaning/disinfection (5,000 times for single-patient use, 156 times for lancing devices); All individual bias < 10 mg/dL (< 75 mg/dL glucose) and < ± 10% (≥ 75 mg/dL glucose) compared with YSI mean.	Appearance, structure, and function of meters regular after cleaning/disinfection (5,000 times for single-patient use, lancing devices 156 times). All individual bias compared with YSI mean < 10 mg/dL at glucose < 75 mg/dL and < ± 10% at glucose ≥ 75 mg/dL.
Disinfection Efficacy Validation	HBV of clinical sera could be efficaciously removed from the Blood Glucose Meter after completing the designed disinfection procedure. (Implied: robust disinfection method to protect users).	HBV of clinical sera could be efficaciously removed from the Blood Glucose Meter provided by OKBiotech CO., Ltd after completing the designed disinfection procedure. Demonstrates robust method to protect users from HBV infection.
Software Validation	Meets the requirements of FDA's guidance document "Guidance for the Content of Pre-market Submission for Software Contained in Medical Devices".	Met the requirements of FDA's guidance document.
Human Factor Study	Ease of Use = high percentage, Label Comprehension = high percentage. (Specific threshold not provided, but implicitly met by reported percentages)	Ease of Use = 98.5%; Label Comprehension = 99.5%.
Electrical Testing	Pass EN 61236-1 EMC Test; Pass EN 60601-1-2 EMC Test; Pass FCC CFR 47 18 Subpart C.	Passed all listed electrical tests (EN 61236-1 EMC, EN 60601-1-2 EMC, FCC CFR 47 18 Subpart C).

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

The document does not explicitly state the sample sizes for the test set for each specific study. It frequently refers to "test results," "data," or "blood samples" without providing the precise number of participants or measurements.

Provenance: Not explicitly stated, but the studies involve "fresh capillary whole blood samples" and "venous whole blood" in a medical device context, suggesting a clinical or laboratory setting. The approval is from the US FDA, implying testing relevant to US regulatory standards. It does not state whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document mentions "glucose analyzer YSI2300" as the reference method for ground truth in several performance tests (Precision, Linearity, System Accuracy, Hematocrit, Temperature for Equipment, Humidity for Equipment, Robustness).
The YSI 2300 STAT Plus Glucose & Lactate Analyzer is a laboratory-grade reference instrument. Thus, the ground truth is established by a highly accurate and precise analytical instrument, not by human experts. The qualifications of the operators of this instrument are not detailed, but it's implied that they are qualified laboratory personnel.

4. Adjudication Method for the Test Set

No adjudication method by human experts is mentioned for the test set. The direct comparison is against a reference instrument (YSI2300).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device is a blood glucose meter, which provides a direct numerical reading, not an interpretation like an imaging device that would typically involve human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the performance tests described (Precision, Linearity, System Accuracy, Interference, etc.) represent standalone performance of the device (meter + test strip system). The device provides a direct quantitative measurement, and these studies evaluate its accuracy and performance independently of human interpretation, although human users operate the device and apply the blood sample. The "Human Factor Study" addresses ease of use and label comprehension for the human operator, but the core performance metrics are device-centric.

7. Type of Ground Truth Used

The primary ground truth used for analytical performance studies is comparison to a laboratory reference instrument, specifically the YSI 2300 STAT Plus Glucose & Lactate Analyzer. This is a highly accurate and precise method for determining blood glucose levels. For the Disinfection Efficacy, the ground truth was the efficacious removal of HBV as per FDA guidance.

8. Sample Size for the Training Set

The document does not provide information on a "training set" sample size. This type of medical device (blood glucose meter) is typically developed through analytical validation of its electrochemical principles and biochemical components, rather than through machine learning model training on large datasets in the way an AI-driven diagnostic would be. The "design verification and validation testing" refers to broader engineering and performance validation rather than machine learning training.

9. How Ground Truth for the Training Set Was Established

As no "training set" for a machine learning model is mentioned or implied, the method for establishing its ground truth is not applicable. The device's "training" in a broad engineering sense would involve iterative design, prototyping, and testing against known glucose concentrations and reference methods to optimize its performance characteristics.

Summary

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510(k) Summary 807.92(c)

SPONSOR

Prodigy Diabetes LLC

Company Address:

Company Name:

2701-A Hutchison McDonald Road Charlotte, NC 28269

Telephone: Fax: Contact Person: 704-285-6400 704-285-6475 Rick Admani

NOV 05 2013

Summary Preparation Date: November 4, 2013

DEVICE NAME	807.92(a)(2)
Trade Name:	Prodigy® Preferred 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)

807.92(a)(1)

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

DEVICE DESCRIPTION

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Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution. The Prodigy No Coding Test Strips utilizes the active enzyme is Glucose Oxidase, derived from Aspergillus niger.

DEVICE INTENDED USE

807.92(a)(5)

Item	Subject device	Predicate Device
Trade Name	Prodigy Preferred BGMS	Prodigy Voice BGMS
Manufacturer	Prodigy Diabetes Care, LLC	Diagnostic Devices, Inc.
K Number		K073118
Similarities
Indications forUse	The Prodigy Preferred Blood GlucoseMonitoring System is intended to beused for the quantitativemeasurement of glucose (sugar) infresh capillary whole blood samplesdrawn from the fingertips, forearm,upper arm, palm, calf or thigh. TheProdigy Preferred Blood GlucoseMonitoring System is intended to beused by a single person and shouldnot be shared.The Prodigy Preferred Blood GlucoseMonitoring System is intended forself testing outside the body (in vitro)	The Prodigy Voice Blood GlucoseMonitoring System is intended for use inthe quantitative measurement ofglucose in fresh capillary whole bloodfrom the finger and the followingalternative sites: the palm, the forearm,the upper-arm, the calf and the thigh. Itis intended for use by healthcareprofessionals and people with diabetesmellitus at home as an aid in monitoringthe effectiveness of diabetes controlprogram. It is not intended for thediagnosis of or screening for diabetesmellitus.The alternative site testing in this

	diagnostic use) by people withdiabetes at home as an aid tomonitor the effectiveness of diabetescontrol. The Prodigy Preferred BloodGlucose Monitoring System shouldnot be used for the diagnosis of orscreening of diabetes or for neonataluse. Alternative site testing shouldbe done only during steady - statetimes (when glucose is not changingrapidly).The Prodigy No Coding Test Stripsare for use with the ProdigyPreferred Blood Glucose Meter toquantitatively measure glucose(sugar) in fresh capillary whole bloodsamples drawn from the fingertips,forearm, upper arm, palm, calf orthigh.	system can be used only duringsteady-state blood glucoseconditions.
Detectionmethod	Amperometry: measuring a currentproduced by a chemical reaction	Amperometry: measuring a currentproduced by a chemical reaction
Enzyme	Glucose oxidase	Glucose oxidase
Test stripcalibration	Code number checking	Code number checking
Temperaturecompensation	Automatic compensation with built-in thermister	Automatic compensation with built-in thermister
Sample volume(µL)	0.7 µL	0.7 µL
Reaction time(sec)	7	7
Measurementrange	20-600 mg/dL	20-600 mg/dL
Operatingcondition	50° F - 104°F (10°C- 40°C), below85% R.H. (noncondensing)	50° F - 104°F (10°C- 40°C), between10% and 85% R.H. (noncondensing)
Strip vialopened usetime	90 days	90 days
Auto shut off(min)	3	3
Alarm	Beeping sound and/or error messagein LCD display	Beeping sound and/or error messagein LCD display
Communication	RS232 port	RS232 port
Differences
Memoryfeature	120 measurements with day andtime	450 measurement with day and time
Day average	7-, 14-, 21-, 28- average glucoseresult	7-, 14-, 21-, 28-, 60- and 90 dayaverage glucose result
Speakingfunction	no	yes
Weight	2.81 in. (L) x 2.375 in. (W) x 0.75 in.(H)71mm (L) x 60mm (W) x 19mm (H)	3.78 in. (L) x 1.7 in. (W) x 0.71 in. (H)95mm (L) x 55mm (W) x 18mm (H)
Dimension	1.6 oz with battery	2.4 ozs
	45 g	68 g
Appearance	Picture / illustration of device	Picture / illustration of device

Predicate Product Comparison Chart

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COMPARISON OF TECHNICAL CHARACTERISTICS

807.92(a)(6)

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

PERFORMANCE TESTING

807.92(b)

Precision test

According to the test results, the pooled and maximum SD were less than 5.0mg/dL at glucose concentration <75mg/dL, and pooled and maximum CV were less than 5.0% at glucose concentration ≥75mg/dL. The maximum individual bias was less than 10% compared with glucose analyzer YSI2300. The test results met the acceptance criteria.

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Linearity

According to our test results, the correlation coefficient is greater than 0.95. That is, our test results and YSI 2300 were highly correlated. The linearity of our measurement is acceptable between 20 to 600 mg/dL. 100 % of the bias of individual glucose results fallen within ±10 %. The test results met the acceptance criteria.

System Accuracy

According to the test results, more than 95% test results of all alternative site tested fall within the acceptance criteria (15mg/dL for blood glucose level <75 mg/dL and 20% for blood glucose level ≥75mg/dL). The system accuracy of finger and AST of Prodigy Preferred Blood Glucose Monitoring System met the requirement of ISO 15197.

Interference

The Prodigy Preferred® Blood Glucose Monitoring System was tested for interfering substances. All the bias of test results were ~ 10% compared with the measurements of the controlled pool. No obvious interference was observed in the interfering substance at therapeutic or physiological levels at three blood glucose levels. Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.

Elevated blood triglyceride, Reducing substances such as uric acid and ascorbic acid, Acetaminophen, Dopa, Methyldopa, L-dopa, and Tolbutamide (when occurring in normal blood or normal therapeutic concentrations) do not significantly affect results. However, abnormally high concentrations in blood may cause inaccurately high results.

Hematocrit

According to the data, when blood sample with HCT between 20% to 60%, all of the individual difference of the tests compared with individual YSI mean were less than ±10%. All of the individual bias of the tests compared with YSI mean in HCT 40% was less than ±10%. All SD were <5mg/dL and all CV were <5%. The test result supported an acceptance HCT range for Prodigy Preferred Blood Glucose Monitoring System was 20% to 60%.

Volume Verification Study

Based on the data, the sample volumes between 0.7to 1 .5µL were fall within acceptable criteria. In order to obtain more accurate results, testing blood glucose value with the Prodigy Preferred Blood Glucose Monitoring System required at least0.7uL of blood

Measurement Internal Determination Test

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The glucose measurements with the check strip before and after high temperature exposure is less than 0.2 mg/dl. The mean difference of the before and after test strip measurements using the control solutions Level N and Level H is less than 3.6 mg/dl for each. The test results exceed the acceptance criteria of 2.0 mg/dL difference for the before and after exposure check strip measurements and 5.0 mg/dL mean difference for the before and after control solution measurements. The meters pass this performance test.

Altitude Study

lt shows the individual results fall within ± 10 % at the altitude from 91 to 3,402 meters. The results meet the acceptance criteria. So it shows no significant effects on Prodigy Preferred Blood Glucose Monitoring System at various altitudes from 298 feet to 11,161 feet (91 to 3,402 meters).

Storage Condition for Prodigy No Coding Test Strips

According to the test results, all the individual bias was less than ± 10 %. The results show all the unused test strips were stable in a period of 24months and 90 days in used vials even after transportation.

Temperature for Equipment

The maximum individual bias of the meters treated to extreme temperature measurements compared with the YSI 2300 were <10% by using venous whole blood. The test results met the acceptance criteria.

Humidity test for Equipment

The maximum individual bias of the meters treated to extreme humidity measurements compared with the YSI 2300were <10% by using venous whole blood. The test results met the acceptance criteria.

Operating Condition for Prodigy No Coding Test Strips According to the test results, the performance of individual bias of the test strips evaluated in the extreme environments was less than ± 10 %, the result meets the acceptance criteria.

Low Temperature Test

The glucose measurements with the check strip before and after low temperature exposure are less than 0.2 mg/dl. The mean difference of the before and after test strip measurements using the control solutions Level Normal and Level High are less than 3.9 mg/dl for each. The test results exceed the acceptance criteria of 2.0 mg/dL difference for the before and after exposure

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check strip measurements and 5.0 mg/dL difference for the before and after control solution measurements. The meters pass this performance test.

Humidity Detection Limit

It shows that all CV of the test results are less than 4 %, that the data is accepted. The total CV of the average values at different humidity levels are less than 4 % for "Normal" and "High" control solution for the humidity range from RH 10 ~ 85%.

High Temperature Test

The test results exceed the acceptance criteria of 2.0 mg/dL difference for the before and after exposure check strip measurements and 5.0 mg/dL mean difference for the before and after control solution measurements. The meters pass this performance test.

Temperature Test

It shows that all precisions of the test results are less than 4 %, so that the data is accepted. The total CV of the average values at different temperatures are less than 4 % for "Normal" and "High" Prodigy control solution for the temperature range from 10 to 40°C.They are passed the temperature with the Operating temperature (10~~40℃) and Storage temperature (4~~40℃), Robustness Test

According to the test results, the appearance, structure and function of the meters were quite regular after cleaning and disinfection cycles including 5,000 times for single-patient use claim, and the lancing devices were the same as the testing meters after 156 times cleaning and disinfection cycles. Also, based on the accuracy test, all the individual bias of the test results compared with YSI mean were less than 10 mg/dL at glucose concentrations < 75 mg/dL and less than ± 10 % at glucose concentrations ≥75 mg/dL. The test results met acceptance criteria.

Disinfection Efficacy Validation Study

In order to evaluate the efficacy of disinfection procedure with specified disinfectant that is DISPATCH®Hospital Cleaner Disinfection Towel with Bleach, coupons from the four test articles, Blood Glucose Meter were tested in this study. Our assay followed the guidance of FDA and carried out in a strict manner for safety considerations. The result revealed that HBV of clinical sera could be efficaciously removed from the Blood Glucose Meter provided by OKBiotech CO.,

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. Ltd after completing the designed disinfection procedure. The study demonstrates the disinfection procedure and virucidal would be a robust method to protect the users to avoid HBV infection.

Software Validation

The Software of Prodigy Preferred Blood Glucose Meter meets the requirements of FDA's guidance document "Guidance for the Content of Pre-market Submission for Software Contained in Medical Devices".

Human Factor Study

Ease of Use = 98.5% Label Comprehension = 99.5%

Electrical Testing

EN 61236-1 EMC Test = Passed EN 60601-1-2 EMC Test = Passed

FCC CFR 47 18 Subpart C = Passed

Design verification and validation testing confirmed that the performance, safety, and effectiveness of the Prodigy Preferred Blood Glucose Monitoring System was equivalent to that of the predicate device.

Conclusion

The Prodigy Preferred Blood Glucose monitoring System is substantially equivalent in its intended use, performance, safety, effectiveness and the underlying scientific and operating principles used, to the predicate Prodigy Voice Blood Glucose Monitoring System (K073118).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a flame.

Public I leulth Service

Food and Drug Administration 10903 New Humpshire Avenue Document Control Center - WO66-6168 Silver Spring, MD 20993-0002

November 5, 2013

PRODIGY DIABETES CARE, LLC C/O E.J. SMITH, CONSULTANT SMITH ASSOCIATES 1468 HARWELL AVENUE CROFTON MD 21114

Re: K122338

Trade/Device Name: Preferred Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: October 28, 2013 Received: October 29, 2013

Dear E.J. 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 r ou may , more or ovisions of the Act include requirements for annual registration, listing of general controls provisions or ractice, 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.

1f 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 SERVICES 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) K122338

Device Name

Prodigy Preferred Blood Glucose Monitoring System

Indications for Use (Describe)

The Prodigy Preferred 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, calf or thigh. The Prodigy Preferred Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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 Center for Devices and Radiological Health (CDRH) (Signature)

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.