The GlucoSure Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. 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.

The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring system using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

Device Description

GlucoSure Voice 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

The provided 510(k) summary for the GlucoSure Voice Blood Glucose Monitoring System offers limited details regarding specific acceptance criteria and the comprehensive study that proves the device meets them. Blood glucose monitoring systems typically demonstrate performance against ISO 15197 standards (or similar regulatory guidance at the time of submission), which specify accuracy requirements. This document, however, mainly provides a high-level overview of the testing conducted.

Here's an attempt to extract and synthesize the information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Results met pass/fail performance criteria," but it does not explicitly list these criteria with quantitative targets. For blood glucose meters, typical acceptance criteria involve accuracy thresholds, often expressed as percentages of readings within a certain range of a reference method, or within a specified error grid. Without this specific detail in the provided text, a table can only approximate based on standard expectations for such devices.

Metric (Implied)	Acceptance Criteria (Implied for this type of device)	Reported Device Performance
Accuracy (Overall for Fingerstick & AST)	Typically, a high percentage of readings within ±15% or ±20% of a reference method for various glucose concentrations (e.g., in accordance with ISO 15197 or similar guidance). Performance within a specific zone on a Clarke Error Grid.	"Results met pass/fail performance criteria." (Specific numerical data not provided in the summary.)
Precision	Defined coefficient of variation (CV) or standard deviation at various glucose levels.	"Non-clinical testing of precision... was also conducted." (Specific numerical data not provided in the summary.)
Linearity	Performance over the device's stated measuring range.	"Non-clinical testing of ...linearity... was also conducted." (Specific numerical data not provided in the summary.)
Environmental Effects (Temperature, Humidity)	Stable performance within specified environmental conditions.	"Non-clinical testing of ...temperature and humidity effects was also conducted." (Specific numerical data not provided in the summary.)
Voice Functionality	Usability and effectiveness for visually impaired users.	"The clinical evaluation included testing of the voice functionality with visually impaired persons with diabetes." (Specific numerical data not provided in the summary.)

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

Sample Size: The document does not specify the exact number of participants or samples in the clinical testing. It mentions "Clinical testing was done with persons with diabetes."
Data Provenance: The country of origin of the data is not explicitly stated. The submitter is based in China (Taiwan), but this does not necessarily mean the clinical study was conducted there. The study was prospective, as it involved "persons with diabetes to verify proper performance."

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

The document does not provide details on the number of experts, their qualifications, or their role in establishing the ground truth. For blood glucose meters, the "ground truth" (reference method) is typically established by laboratory-grade glucose analyzers, not by human expert consensus on interpretations.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for blood glucose meter accuracy studies. The comparison is generally against a quantitative reference method, not subjective interpretations requiring adjudication.

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 monitoring system, not an imaging or diagnostic device that involves human "readers" interpreting cases with or without AI assistance. The voice functionality assists visually impaired users in operating the device, but it's not an AI assisting human interpretation of medical data in an MRMC context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The performance of the GlucoSure Voice meter itself (the algorithm and hardware for glucose measurement) without human interpretation is the primary focus of the accuracy clinical testing. The meter generates a numerical glucose reading, and its accuracy is assessed against a reference method. The human "in-the-loop" aspects relate to proper sample collection and device operation, not interpretation of an algorithm's output in the diagnostic sense.

7. The Type of Ground Truth Used

The ground truth for the accuracy testing was presumably derived from a laboratory reference method (e.g., a YSI glucose analyzer or a similar high-accuracy clinical chemistry analyzer) for glucose measurement. The summary states: "Professional fingertip meter results were compared with AST results collected both by professionals and by persons with diabetes." This implies a comparison to a more accurate, professionally obtained reading or a lab reference.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI models. Blood glucose meters typically do not involve such training sets in the same way modern AI algorithms do. Their performance is based on the underlying electrochemical or enzymatic reaction and calibration, not a trained statistical model in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set (in the AI/ML sense) is described or implied for this type of device.

Summary

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K073137
APR - 1 2008

APR - 1 2008

510(k) Summary :

Submitter:	Apex 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. ShenApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078 CHINA (TAIWAN)Phone: 011-886-3-5641952FAX: 011-886-3-5678302
Date Prepared:	January 9, 2008
Trade Name:	GlucoSure Voice Blood Glucose Monitoring System
Classification:	Glucose test system, 21 CFR 862.1345, Class II
Product Codes:	CGA, NBW, JJX
Predicate Device:	GlucoTrack BGM, K062799
Device Description:	GlucoSure Voice consists of a meter, test strips, and control solutionsfor use in measuring blood glucose as an aid to monitor theeffectiveness of diabetes control.
Intended Use:	The GlucoSure Voice Blood Glucose Monitoring System is intended for thequantitative measurement of glucose in fresh capillary whole blood samplesdrawn from the fingertips, forearm, or palm. Testing is done outside thebody ( In Vitro diagnostic use). The meter includes voice functionality toassist visually impaired users. It is indicated for both lay use by people withdiabetes and in a clinical setting by healthcare professionals, as an aid tomonitoring levels in Diabetes Mellitus.---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------The Intended Use is the same as that as the predicate but with theaddition of 1) Alternate Site Testing and 2) voice functionality.
Functional andSafety Testing:	Clinical testing was done with persons with diabetes to verify properperformance for fingerstick and Alternate Site Testing (AST) usingpalm and forearm blood sampling. Professional fingertip meterresults were 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. The clinical evaluationincluded testing of the voice functionality with visually impairedpersons with diabetes.Non-clinical testing of precision, linearity, and temperature andhumidity effects was also conducted.
Conclusion:	The modification to the original device (adding voice functionality) andto the Intended Use (adding AST sampling) does not adversely affectperformance and the modified device is substantially equivalent to theunmodified predicate device.

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510(k) Summary (continued)

Apex BioTechnology Corp. GlucoSure Voice Blood Glucose Monitoring System

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 image of an eagle or bird-like figure, with its wings spread and head facing to the left.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Apex Biotechnology Corp. c/o Mr. Thomas Shen Chairman & CEO No. 7, Li-Hsin Road V Hsinchu Science Park Hsinchu, Taiwan, R.O.C. 30078 APR - 1 2008

Re: K073137

Trade Name: GlucoSure Voice Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: February 04, 2008 Received: February 15, 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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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) 276-0490. 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.

Yean 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: K073137

Device Name: GlucoSure Voice Blood Glucose Monitoring System

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

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

he-Counter Use
TR 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)

Carol C. Benam
Sign-Off

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ice of In Vitro Diagnostic Device ation and Safety

K07313

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Indications for Use Statement

510(k) Number: K073137

Device Name: Contrex Plus Glucose Control Solution

(Part of the GlucoSure Voice Blood Glucose Monitoring System)

Indications For Use:

Prescription Use _____________ (Part 21 CFR 801 Subpart D)

AND/OR (21 CFR 801 Subpart C)

Over-The-Counter Use X

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

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

Carol C. Benson

Division Sign-Off

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ion Sign-Off

Tice of In Vitro Diagnostic Device fration and Safety

K073137

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.