The Prodigy Blood Glucose Test System is intended for use in the quantitative measurement of glucose in whole blood taken from the finger. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

The Prodigy Blood Glucose Test System is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. It is intended for use by people with diabetes mellitus at home (Over -the-Counter) as an aid in monitoring the effectiveness of diabetes control program. The Prodigy blood glucose test system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. It is not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates.

The Prodigy meter is to be used with the Prodigy Blood Glucose Test Strip, and the Prodigy Glucose Control Solutions.

Device Description

The Prodigy glucose test 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided text is a 510(k) summary for a medical device. This document primarily focuses on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already on the market. It often doesn't contain detailed, standalone clinical trial reports with full statistical breakdowns, specific acceptance criteria for performance metrics (like accuracy targets), or comprehensive study methodologies. As such, some of the requested information (especially quantitative acceptance criteria, exact sample sizes for training, and specific details about ground truth establishment for training data) is not explicitly stated in this type of document. I will extract what is available and clearly state what is not present.

Acceptance Criteria and Device Performance

The 510(k) summary primarily establishes substantial equivalence by demonstrating that the new device, the Prodigy Blood Glucose Test System, is similar to its predicate device (TaiDoc Technology Corporation, K042005) in terms of technology and performance. While specific numerical acceptance criteria (e.g., "95% of readings must be within ±X% of reference") are not explicitly listed in the provided text for device performance, the overall acceptance criterion for the submission is that the device is "as safe and effective as the predicate."

The text states: "The results of clinical and non-clinical testing indicate that the new device is as safe and effective as the predicate." This implies that the device met performance standards comparable to those accepted for the predicate.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Feature/Criterion (Implied)	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Prodigy Blood Glucose Test System)	Notes
Enzyme	Glucose oxidase	Glucose oxidase	Identical to predicate.
Test Range	20-600 mg/dL	20-600 mg/dL	Identical to predicate.
Calibration	Code strip	Code strip	Identical to predicate.
Sample Volume	1.8-2.5 uL	1.8-2.5 uL	Identical to predicate.
Test Time	10 sec.	10 sec.	Identical to predicate.
Operating Condition	10 - 40°C, 10 - 90 % R.H.	10 - 40°C, 10 - 90 % R.H.	Identical to predicate.
Storage/Transportation	-20 - 70°C, 5 - 95 % R.H.	-20 - 70°C, 5 - 95 % R.H.	Identical to predicate.
Overall Safety/Effectiveness	As safe and effective as predicate	Clinical and non-clinical testing results support this claim.	This is the overarching criterion for 510(k) substantial equivalence. Specific performance metrics (e.g., accuracy against a lab reference) are not detailed here.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: The exact sample size for the test set (clinical study group) is not explicitly stated in the provided document. The document mentions "clinical and non-clinical testing data," but does not give numerical figures for the number of patients or samples.
- Data Provenance: The document does not specify the country of origin of the data. It mentions "Diagnostic Devices, Inc.,Inc. Address: 8935 NW 27th street, Miami, FL 33172. U.S.A.", which implies the company is based in the US, but this doesn't confirm the origin of the clinical data. The data is retrospective or prospective is not explicitly stated, though clinical studies for 510(k) are typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. For a blood glucose meter, the "ground truth" would typically come from a laboratory reference method (e.g., YSI analyzer), not expert human adjudication in the way it might for imaging.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This concept of "adjudication" is generally relevant for subjective assessments (like interpreting medical images). For a quantitative device like a blood glucose meter, the ground truth is established by a more accurate reference method, not by expert adjudication. Therefore, an adjudication method is not applicable and not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is used for diagnostic imaging systems where human readers interpret cases, often with and without AI assistance, to measure the AI's impact on human performance. The Prodigy Blood Glucose Test System is a direct quantitative measurement device, not an image interpretation aid. Therefore, this question is not applicable to this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. A blood glucose meter inherently operates as a "standalone" algorithm/device in that it directly measures glucose and provides a numerical output without requiring human interpretation or decision-making in its core function. The "clinical and non-clinical testing data" mentioned refers to the performance of the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state the ground truth method. However, for blood glucose meters, the standard ground truth is typically a laboratory reference method (e.g., hexokinase method on a YSI analyzer or similar highly accurate laboratory instrument).
The sample size for the training set:
- This information is not provided in the 510(k) summary. Given that this is a relatively older electrochemical biosensor, the concept of a "training set" for a machine learning algorithm in the modern sense (with large datasets) might not be directly applicable as it would be for AI/ML-driven devices. Device development often involves calibration data, but it's not usually referred to as a "training set" in this context or documented with specific sizes in 510(k) summaries.
How the ground truth for the training set was established:
- As with the training set details, this is not explicitly provided and not typically detailed in 510(k) summaries for this type of device. If there was a "training" or calibration phase, the ground truth would likely have been established using a highly accurate laboratory reference method, similar to the test set.

Summary

{0}------------------------------------------------

510 (k) Summary

General Information Establishment

JUL - 6 2006

Applicant: DIAGNOSTIC DEVICES, INC.Inc. Address: 8935 NW 27th street, Miami, FL 33172. U.S.A. Registration Number: 3004622211 Contact Person: Rick Admani Abulhaj Director of Finance and Operation TEL: 1-800-2432636 FAX: 1-305-6205220 Data submitted: December 21, 2005

Device

Proprietary /Trade Name: Prodigy Blood Glucose Test System Common Name: Blood Glucose Test System Classification Name: SYSTEM, TEST BLOOD GLUCOSE, Class II Regulation sections: 21 CFR § 862.13485, Glucose Test System 21 CFR § 862.1660, Quality Control Material, assayed and Unassayed. Classification: Class II (Glucose Test System) Class I -reserved (Quality Control Matcrial) Product code: NBW, CGA (Glucose Test System) JJX (Quality Control Material) Panel: 75 (Clinical Chemistry)-Glucose Test system and Quality Control Material

Safety and Effective Information

Predicate Device:

Claim of Substantial Equivalence (SE) is made to TaiDoc Technology Corporation. K042005, Achtung TD-4207/ Clever Chek TD-4209/ Clever Chek TD-4222 Glucose Test Systems.

{1}------------------------------------------------

Indications for Use:

Device Description:

Safety and Effectiveness, comparison to predicate device:

The results of clinical and non-clinical testing indicate that the new device is as safe and effective as the predicate.

Similarities
Item	New Device: Prodigy	Predicate K042005
Enzyme	Glucose oxidase	Glucose oxidase
Test range	20-600 mg/dL	20-600 mg/dL
Test strip calibration	Code strip	Code strip
Sample volume	1.8-2.5 uL	1.8-2.5 uL
Test time	10 sec.	10 sec.
Operating condition	10 - 40°C	10 - 40°C
and humidity range	10 - 90 % R.H.	10 - 90 % R.H.
Storage/Transportationcondition	-20 - 70°C5 - 95 % R.H.	-20 - 70°C5 - 95 % R.H.
Difference
Item	New Device: Prodigy	Predicate K042005
Size	88mm X 62mm X 22mm	80mm X 60mm X 20mm
Weight	26.5 g	48.79 g

Substantial Equivalence Chart:

{2}------------------------------------------------

Conclusion

After analyzing clinical and non-clinical testing data, it is the conclusion of Diagnostic Devices, Inc.,Inc. that the prodigy blood Glucose Test system is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalence to the predicate device.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and three horizontal bars below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Diagnostic Devices Inc. c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm& Associates PO Box 7007 Deerfield IL 60015

Re: K053593

Trade/Device Name: Prodigy Blood Glucose Test System Regulation Number: 21 CFR§ 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: June 12, 2006 Received: June 14, 2006

Dear Mr. Kamm:

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 udictions 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 provisiops of the I ( The general controls provisions of the Act include requirements for annual registration, inte rece devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JUL - 6 2006

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your revire, can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition FDA may publish further announcements concerning your device in the Federal Degister.

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 Isiting (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing pratice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820),

{4}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, pervoits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tloin the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number: K053593

Device Name: Prodigy Blood Glucose Test System

Indications For Use:

The Prodiqy Blood Glucose Test System is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. It is intended for use by people with diabetes mellitus at home (Over -the-Counter) as an aid in monitoring the effectiveness of diabetes control program. The Prodigy blood glucose test system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. It is not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates.

The Prodigy meter is to be used with the Prodigy Blood Glucose Test Strip, and the Prodigy Glucose Control Solutions.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carole Benson
Revision Sign-Off

Page 1 of -

Office of In Vitro Diagnostic Device Evaluation and Safety

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

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.