The GlucoSure Star Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood taken from fingertips, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). The GlucoSure Star System is plasma-calibrated for easy comparison to lab results. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus.

Device Description

GlucoSure Star consists of a meter, test strips, and control solutions for use in measuring blood glucose as an aid to monitor the effectiveness of diabetes control.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the GlucoSure Star Blood Glucose Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only explicitly states that "Results met pass/fail performance criteria" without detailing the specific criteria or the exact performance values achieved. Based on the "Functional and Safety Testing" section, the evaluation methods were linear regression analysis, Clarke Error Grid analysis, and bias analysis. While the document asserts the results met criteria, the specific numerical targets for these analyses are not mentioned.

Acceptance Criteria	Reported Device Performance
Specific Pass/Fail Performance Criteria for Linear Regression Analysis	"Results met pass/fail performance criteria."
Specific Pass/Fail Performance Criteria for Clarke Error Grid Analysis	"Results met pass/fail performance criteria."
Specific Pass/Fail Performance Criteria for Bias Analysis	"Results met pass/fail performance criteria."

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

Sample Size: Not explicitly stated. The text only mentions "Clinical testing was done with persons with diabetes."
Data Provenance: Not explicitly stated. It indicates "Clinical testing was done with persons with diabetes." The submitter is from Taiwan, ROC, which might imply the study was conducted there, but this is not confirmed. The study was retrospective or prospective is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated.
Qualifications of Experts: The text states, "Professional fingertip meter results were compared with AST results collected both by professionals and by persons with diabetes." This implies healthcare professionals were involved in collecting data and establishing comparison points, but their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication Method

Adjudication Method: Not explicitly stated. The study involved comparing professional fingertip meter results with AST results. It doesn't describe a process of multiple experts independently reviewing and then adjudicating discrepancies.

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

MRMC Study: No. This type of study is typically for evaluating human reader performance with and without AI assistance for interpretative tasks. The GlucoSure Star is a blood glucose monitoring system, and its evaluation focuses on the accuracy of its quantitative measurements against a reference.

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

Standalone Study: Yes, in essence. The study's purpose was to verify the proper performance of the device itself (GlucoSure Star) for Alternate Site Testing (AST). While humans (professionals and persons with diabetes) collected the samples and operated the device, the core evaluation was the accuracy of the device's measurements compared to a reference method (professional fingertip meter results). The "algorithm" here is the device's inherent measurement capability.

7. Type of Ground Truth Used

Ground Truth Type: Clinical comparison to a predicate/reference method. The study used "Professional fingertip meter results" as the comparison/reference point for the Alternate Site Testing (AST) results from the GlucoSure Star. This is a common approach for establishing the accuracy of new blood glucose monitoring systems against established, accepted methods.

8. Sample Size for the Training Set

Sample Size: Not applicable/not stated. The provided text describes a clinical validation study for the device, not a study for an AI algorithm that typically requires a training set. The GlucoSure Star appears to be a traditional medical device (blood glucose meter) rather than an AI-powered diagnostic system requiring a training phase in the AI sense.

9. How Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable. As mentioned above, this device does not appear to be an AI algorithm with a training set.

Summary

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K073648

APR 11.0 2008

5 510(k) Summary

Submitter:	Thomas Y.S. ShenApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078 CHINA (TAIWAN)Phone: 011-886-3-5641952FAX: 011-886-3-5678302
Contact Person:	Thomas Y.S. Shen
Date Prepared:	December 21, 2007
Trade Name:	GlucoSure Star Blood Glucose Monitoring System
Classification:	Glucose test system, 21 CFR 862.1345, Class II
Product Codes:	CGA, NBW, JJX
Predicate Device:	GlucoTrack Blood Glucose Monitoring System (K062799)
DeviceDescription:	GlucoSure Star consists of a meter, test strips, and controlsolutions for use in measuring blood glucose as an aid to monitorthe effectiveness of diabetes control.
Intended Use:	"The GlucoSure Star Blood Glucose Monitoring System isintended for the quantitative measurement of qlucose in freshcapillary whole blood taken from fingertips, palm, or forearm.Testing is done outside the body (In Vitro diagnostic use). It isindicated for both lay use by people with diabetes and in aclinical setting by healthcare professionals, as an aid tomonitoring levels in Diabetes Mellitus."The GlucoSure Star is identical to the GlucoTrack except for theaddition of the palm and forearm sampling site claims.
Functional andSafety Testing:	Clinical testing was done with persons with diabetes to verifyproper performance for Alternate Site Testing (AST) using palmand forearm blood sampling. Professional fingertip meter resultswere compared with AST results collected both by professionalsand by persons with diabetes. Data were analyzed by linearregression analysis, Clarke Error Grid analysis and bias analysis.Results met pass/fail performance criteria.
Conclusion:	The addition of the AST blood sampling claim does not adverselyaffect performance of the device. The new device with themodified AST blood sampling claim is substantially equivalent tothe predicate device with its original Intended Use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Apcx Biotechnology Corp. c/o Mr. Thomas Y. S. Shen Chairman & CEO No. 7, Li-Hsin Road V Hsinchu Science Park Hsinchu, 30078 Taiwan, ROC

APRIC 2008

Re: K073648

Trade Name: Glucosure Star Blood Glucose Monitoring System, Model as90000e1 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA Dated: February 21, 2008 Received: February 25, 2008

Dear Mr. Shen:

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 (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 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).

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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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. 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 Statement

510(k) Number (if known): ≤673648

Device Name: GlucoSure Star Blood Glucose Monitoring System

Indications For Use:

GlucoSure Star Blood Glucose Monitoring System:

GlucoSure Star Test Strips:

The GlucoSure Star Blood Glucose Test Strips are to be used with the GlucoSure Star Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

D/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)

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

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

S100(2) K073649

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.