AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP by APEX BIOTECHNOLOGY CORP.

The AutoSure Voice 3 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearn, 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 lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

AutoSure Blood Glucose Test Strips:

The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II and AutoSure Voice 3 Blood Glucose Meters to quantitatively measure glucose in capillary whole Hood taken from fingertips, palm, or forearm. The AutoSure Voice II and AutoSure Voice 3 Blood Glucose Monitoring Systems are plasma-calibrated for easy comparison to lab results. They are intended for self-testing by persons with diabetes and should only be used by a single patient. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

Device Description

The AutoSure Voice 3 blood glucose monitoring system consists of the AutoSure Voice 3 meter and AutoSure Test Strips. It is used for testing of blood glucose by self-testers at home.

AI/ML Overview

The provided 510(k) summary for the "AutoSure Voice 3 Blood Glucose Monitoring System" and "AutoSure Blood Glucose Test Strips" does not contain specific acceptance criteria or detailed study results beyond a general statement of "substantial equivalence." It indicates that an "accuracy study" was performed but does not provide the quantitative results, sample sizes, or methodology details required to fully address your request.

Therefore, many sections of your request cannot be fulfilled by the provided document.

Here's a breakdown of what can and cannot be answered:

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

Acceptance Criteria: Not explicitly stated in the provided text. For blood glucose meters, regulatory bodies typically have established accuracy criteria (e.g., ISO 15197 for in vitro diagnostic test systems). However, these specific criteria are not listed in this submission.
Reported Device Performance: The document only states that "Results demonstrate substantial equivalence to the predicate device" from an accuracy study. No quantitative performance metrics (e.g., mean absolute relative difference, percentage of results within a certain range of a reference method) are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for the accuracy study.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 applicable to a blood glucose monitoring system accuracy study. The "ground truth" (reference value) for blood glucose is typically established using a laboratory-based reference method (e.g., YSI analyzer) operated by trained laboratory professionals, not by medical "experts" in the context of interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept is not applicable to an accuracy study for a blood glucose meter. Adjudication methods are typically used in studies where subjective interpretation is involved (e.g., radiology image reading).

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 is not applicable. This device is a blood glucose meter, not an AI-assisted diagnostic tool that involves "human readers" or "AI assistance" in the typical sense of an MRMC study.

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

This question is less relevant in its typical framing. A blood glucose meter inherently provides a "standalone" reading based on its internal algorithm and sensor. The accuracy study described is essentially evaluating the "standalone" performance of the meter against a reference method. No human "in-the-loop" performance (beyond the user operating the device) would be separately studied in this context.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The ground truth for blood glucose accuracy studies is typically a laboratory-based reference method (e.g., a central laboratory analyzer measuring plasma glucose, often a YSI analyzer). The document states, "The AutoSure Voice II and AutoSure Voice 3 Blood Glucose Monitoring Systems are plasma-calibrated for easy comparison to lab results," implying a comparison to laboratory reference values.

8. The sample size for the training set

The document does not describe the development or training of an algorithm in a way that would imply a distinct "training set" in the context of machine learning. Blood glucose meters are generally calibrated during manufacturing, and their algorithms are based on electrochemical principles, not typically on machine learning models requiring large "training sets" of patient data.

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

As above, the concept of a "training set" in the machine learning sense is not applicable based on the provided information for this type of device. Calibration and validation are done against reference methods.

Summary based on available information:

Category	Information from 510(k) Summary
1. Acceptance Criteria & Reported Performance	Acceptance Criteria: Not explicitly stated. Reported Performance: "Results demonstrate substantial equivalence to the predicate device" in an accuracy study. No quantitative performance metrics are provided.
2. Test Set Sample Size & Data Provenance	Sample Size: Not specified. Data Provenance: Not specified (e.g., country, retrospective/prospective).
3. Number & Qualifications of Experts for Ground Truth	Not applicable for a blood glucose meter accuracy study. Ground truth is established by a laboratory reference method.
4. Adjudication Method for Test Set	Not applicable for a blood glucose meter accuracy study.
5. MRMC Comparative Effectiveness Study (AI vs. without AI)	Not applicable; device is a blood glucose meter, not an AI-assisted diagnostic.
6. Standalone Performance Study (Algorithm only)	An "accuracy study" was performed, which evaluates the standalone performance of the device. The document states, "An accuracy study was performed with blood testing by healthcare professionals."
7. Type of Ground Truth Used	Implied to be a laboratory-based reference method (e.g., plasma-calibrated for comparison to lab results).
8. Training Set Sample Size	Not applicable/specified. The device uses an "algorithm" but not in the context of machine learning requiring a training set in the typical sense; it relies on electrochemical principles and calibration.
9. How Ground Truth for Training Set was Established	Not applicable/specified. Calibration is performed against reference methods.

Additional Notes:

The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (AutoSure Voice II meter). This type of submission often omits the granular detail of performance studies that would be required for a novel device, as the primary goal is to show similarity to an already cleared device.

Summary

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

510(k) Summary

Submitter:	Hsue-mei LeeManager of Quality Assurance DepartmentApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302
Contact Person:	Hsue-mei LeeManager of Quality Assurance DepartmentApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302
Date Prepared:	April 18, 2011
Trade Names:	AutoSure Voice 3 Blood Glucose Monitoring System,AutoSure Blood Glucose Test Strips
Classification:	Glucose test system, 21 CFR 862.1345, Class II
Product Codes:	CGA, NBW
Predicate Devices:	AutoSure Voice II meter and AutoSure test strips
Device Description:	The AutoSure Voice 3 blood glucose monitoring system consists of theAutoSure Voice 3 meter and AutoSure Test Strips. It is used for testingof blood glucose by self-testers at home.

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

510(k) Summary (Continued)

Intended Use:	System: The AutoSure Voice 3 Blood Glucose Monitoring System isintended for the quantitative measurement of glucose in fresh capillary wholeblood samples drawn from the fingertips, forearm, or palm. Testing is doneoutside the body (In Vitro diagnostic use). It is indicated for lay use bypeople with diabetes as an aid to monitoring levels in Diabetes Mellitus andshould only be used by a single patient. It is not indicated for the diagnosisor screening of diabetes or for neonatal use.Test Strip: The AutoSure Blood Glucose Test Strips are to be used with theAutoSure Voice II and AutoSure Voice 3 Blood Glucose Meters toquantitatively measure glucose in capillary whole blood taken fromfingertips, palm, or forearm. The AutoSure Voice II and AutoSure Voice 3Blood Glucose Monitoring Systems are plasma-calibrated for easycomparison to lab results. They are intended for self-testing by persons withdiabetes and should be used by a single patient. They are not indicated forthe diagnosis or screening of diabetes or for neonatal use.
Comparison ofTechnologicalCharacteristics:	The AutoSure Voice 3 meter uses the same test algorithm, test strip, andcontrol solutions as the predicate. Meter dimensions and button locationswere modified relative to the predicate.
Non-ClinicalTesting:	Testing was conducted as follows: Software verification and validation,software integration, linearity, strip holder reliability, test stripnoninterchangeability, and EMC & Electrical Safety. Results demonstratesubstantial equivalence to the predicate device.
Clinical Testing	An accuracy study was performed with blood testing by healthcareprofessionals. Results demonstrate substantial equivalence to the predicatedevice.
Conclusion:	Clinical and non-clinical testing demonstrated that the AutoSure Voice 3meter with the AutoSure Test Strip perform in a substantially equivalentmanner to that of the predicate device. We conclude that the AutoSure Voice3 system is substantially equivalent to the predicate device.

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

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 stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol, emphasizing the department's name and national scope.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

APR 28 2011

Apex Biotechnology Corp. c/o Ms. Lisa Liu No. 7, Li-Hsin Road V Hsinchu Science Park Hsinchu, China (Taiwan) 30078

Re: K102481

Trade Name: AutoSure Voice 3 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: April 18, 2011 Received: April 20, 2011

Dear Ms. Liu:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CFR Parts 801 and 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

C.C.

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

Enclosure

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

Indications for Use Statement

510(k) Number (if known): K102481

Device Name: AutoSure Voice 3 Blood Glucose Monitoring System Indications for Use:

AutoSure Voice 3 Blood Glucose Monitoring System:

AutoSure Blood Glucose Test Strips:

Prescription Use J Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (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 of

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

510(k) R/024

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.