The G4™ Meter device is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4™ 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 arm.

The G4™ Test Strips is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4™ 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 arm.

The G4™ Control Solutions are a red liquid which is to be used to check that both the G4TM meter and G4TM test strips are working together properly. It contains a known range of glucose as specified on the vial.

Device Description

The G4TM Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in capillary whole blood, which is used with the G4TM 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 does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The 510(k) summary focuses on establishing substantial equivalence to a predicate device rather than providing a performance study report with acceptance criteria and results.

Here's what can be inferred from the provided text, and what is missing:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in the document. For glucose meters, acceptance criteria typically involve accuracy standards (e.g., ISO 15197 or CLSI guidelines) such as percentage of results within a certain margin of a reference method (e.g., ±15% or ±0.83 mmol/L for glucose < 5.55 mmol/L and ±15% for glucose ≥ 5.55 mmol/L).
Reported Device Performance: Not detailed in the provided text. The document states that the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar, but no specific performance data (e.g., bias, precision, linearity) is included.

2. Sample size used for the test set and the data provenance:

Sample Size: Not mentioned.
Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no specific test set or ground truth establishment by experts is described for performance evaluation. For glucose meters, ground truth is typically established by laboratory reference methods, not expert consensus.

4. Adjudication method for the test set:

Not applicable as no specific test set or adjudication process is described.

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:

Not applicable. This device is a blood glucose test system, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The G4™ Meter is a standalone device for measuring glucose. Its "performance" would be its accuracy and precision against a reference method, not an algorithm's performance in a human-in-the-loop context. The document does not provide details of such a standalone performance study.

7. The type of ground truth used:

Not explicitly stated, but for blood glucose meters, the ground truth is typically established by a laboratory reference method (e.g., a YSI analyzer or similar a high-precision glucose analysis instrument). The document implies that the device's performance is compared to such a standard through the substantial equivalence claim, but no details are given.

8. The sample size for the training set:

Not applicable. This medical device (blood glucose meter) is an in vitro diagnostic that measures a physiological parameter based on an electrochemical reaction. It is not an AI/ML-based device that requires a "training set" in the conventional sense. Its development would involve calibration and validation, but not machine learning training.

9. How the ground truth for the training set was established:

Not applicable for the reasons stated above (not an AI/ML device requiring a training set).

Summary of what the document does provide:

Device Name: G4™ Meter, G4™ Test Strips, G4™ Control Solutions
Intended Use: Quantitative measurement of glucose level in capillary whole blood for monitoring diabetes management in home and clinical settings.
Principle of Test: Electrochemical signal generated by glucose dehydrogenase reacting to electrodes.
Predicate Device: LifeScan, Inc. OneTouch® Ultra® (and others listed in the conclusion).
Conclusion: Substantially equivalent to the predicate devices.

Summary

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APR 14 2006

K051651

510(k) SUMMARY (As required by 21.CFR.807.92)

Introduction:	According to the requirements of 21 CFR.807.92, the followinginformation provides sufficient data to understand the basis for adetermination of substantial equivalence.
Submitted By:	US Diagnostics, Inc.,304 Park Avenue SouthSuite 218New York, NY 10010
Contact Person:	Edward LetkoPhone: 917-402-5900Fax: 212-202-5173
Date Summary,Prepared:	March 07, 2006
Device Name:	Propriety Name: G4TMCommon Name: Blood Glucose Test SystemClassification Name: Class II, 862.1345 Glucose Blood Tester
Predicate Device:	We claim substantial equivalence to the LifeScan, Inc.,OneTouch® Ultra®.
DeviceDescription:	The G4TM Monitor is an in vitro diagnostic device designed formeasuring the concentration of glucose in capillary whole blood, whichis used with the G4TM Test Strips.
	The test principle is:
	This device is an in vitro diagnostic product intended for themeasurement of glucose concentration in human blood. The principle ofthe test relies upon a specific type of glucose in the blood sample, thedehydrogenase glucose that reacts to electrodes in the test strip. The teststrip employs an electrochemical signal generating an electrical currentthat will stimulate a chemical reaction. This reaction is measured by theMeter and displayed as your blood glucose result.
Intended Use:	The G4TM Diabetes Monitoring System is used for the quantitativemeasurement of glucose level in capillary whole blood as an aid inmonitoring the effectiveness of diabetes management in the home and inclinical settings. G4TM System is for
	testing outside the body (in vitro diagnostic use only). Testing sitesinclude the traditional fingertip testing along with alternate sitetesting on the forearm giving it an attractive, nearly painlessalternative to the more painful fingertip site. The G4TM ControlSolutions are a red liquid which is to be used to check that both theG4TM meter and G4TM test strips are working together properly. Itcontains a known range of glucose as specified on the vial.
Comparison to
Predicate Device:	The US Diagnostics, Inc. G4TM Module is substantially equivalentto the other products in commercial distribution intended forsimilar use. The most notable, it is substantially equivalent to thecurrently marketed item, the OneTouch ® Ultra ® by LifeScan, Inc.
Conclusion:	The G4TM Blood Glucose Monitoring System is substantiallyequivalent to the following predicate devices: K024194 –LifeScan, Inc. OneTouch ® Ultra ®K984261 – LifeScan, Inc. SURESTEP ®K021513 – Roche Diagnostics Corp. Accu-Chek Advantage

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510(k) Summary, Continued

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Edward Letko Managing Director US Diagnostics, Inc. 304 Park Avenue South Suite 218 New York, NY 10010

APR 1 4 2006

Re: K051651

Trade/Device Name: G4™ Meter, G4™ Test Strips, G4™ Control Solutions Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: March 10, 2006 Received: March10, 2006

Dear Mr. Letko

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 cither class II (Special Controls) or class III (PMA), 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 Eederal 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).

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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 (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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Albete Gutt

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

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Indications for Use

510(k) Number: K051651

Device Name: G4TM

Indications For Use: The G4™ Meter device is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4™ 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 arm.

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

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

(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

C.A.

Axon Signature

Page 1 of

Tice of In Vitro Diagnostic Devi-Anation and Cafaty

. L. G. S.

Confidential US Diagnostics, Inc.

4 12/2006

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.