The GS Infinity TM Meter device is used along with the G5 Infinity TM Test Strips for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes manage:nent in the home by patients with diabetes and in clinical settings by healthcare professionals. G5 Infinity TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the dorsal palm, ventral palm, forearm, upper arm, calf and thigh. The G5 Infinity™ Blood Glucose Monitoring System is not intended for screening or diagnosis of diabetes and also not for use with neonates.

Device Description

The Infinity ™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the Infinity ™ Test Strips.
The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

AI/ML Overview

The provided text describes the U.S. Diagnostics, Inc. G5 Infinity™ Blood Glucose Monitoring System, including its intended use and comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document is a 510(k) summary and clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results that would include acceptance criteria and specific data about how those criteria were met.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the given document:

1. A table of acceptance criteria and the reported device performance: This information is not available in the provided text. The document refers to "substantial equivalence" to predicate devices without listing specific performance metrics or their acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not available in the provided text.
5. 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: This information is not available in the provided text. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not available in the provided text. The device is a "Blood Glucose Test System" for quantitative measurement of glucose, implying a direct output rather than an "algorithm only" performance in the context of interpretation by human readers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not available in the provided text. For a blood glucose monitor, the "ground truth" would typically refer to a reference laboratory method for glucose measurement, but this is not mentioned.
8. The sample size for the training set: This information is not available in the provided text.
9. How the ground truth for the training set was established: This information is not available in the provided text.

Summary

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

KORZIO|

FEB 2.0 2009

510(k) SUMMARY

(As required by 21.CFR.807.92)

Introduction:	According to the requirements of 21 CFR.807.92, the following information provides sufficient data to understand the basis for a determination of substantial equivalence.
Submitted By:	US Diagnostics, Inc. 304 Park Avenue South Suite 218 New York, NY 10010
Contact Person:	Edward Letko Phone: 917-402-5900 Fax: 212-202-5173
Date Summary,Prepared:	February 5, 2009
Device Name:	Propriety Name: G5 Infinity™ Common Name: Blood Glucose Test System Classification Name: Class II, 862.1345 Glucose Blood Tester
Predicate Device:	We claim substantial equivalence to the LifeScan, Inc., OneTouch® Ultra®.
DeviceDescription:	The Infinity ™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the Infinity ™ Test Strips.The test principle is:This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.

Intended Use: The Infinity ™ Meter device is used along with the Infinity ™ Test Strips is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. Infinity TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the dorsal palm, ventral palm, forearm, upper arm, calf and thigh.

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

510(k) Summary, Continued

giving it an attractive, nearly painless alternative to the more painful fingertip site.

Comparison to Predicate Device:

The US Diagnostics, Inc. Infinity ™ Module is substantially equivalent to the other products in commercial distribution intended for similar use. The most notable, it is substantially equivalent to the currently marketed item, the OneTouch® Ultra® by LifeScan, Inc.

The Infinity ™ Blood Glucose Monitoring System is substantially Conclusion: equivalent to the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 -- LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, a common symbol associated with the United States government. The seal is rendered in black and white.

Re:

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

U.S. Diagnostics, Inc. c/o Jonathan Johnson 304 Park Avenue South Suite 218 New York, NY 10010-4301

FEB 2 0 2009

K082201 Trade Name: G5 Infinity Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Blood Glucose Test System, Glucose Oxidase Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: February 9, 2009 Received: February 10, 2009

Dear Mr. Johnson:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. .

If your device is classified (see above) into either class II (Special: Controls) or class III (BMA), it may be subject to such additional controls. Existing major regulations affecting your device 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

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, permits 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 (301) 594-3084. 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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

Indication for Use

510(k) Number (if known): K082201

Device Name: G5 InfinityTM Blood Glucose Monitoring System

Indication For Use:

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

(PLEASE.DONNOT WRITE BELOW THIS LINE; CONTINUE QN ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Ruta Chesler

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082201

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.