AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 by APEX BIOTECHNOLOGY CORP.

The AutoSure 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. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The AutoSure Voice Blood Glucose Test Strips are to be used with the AutoSure Voice Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice System is plasma-calibrated for easy comparison to lab result. The AutoSure Voice Blood Glucose Monitoring System is intended for self-testing by persons with diabetes and by health care professionals. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

Device Description

AutoSure 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 text describes the 510(k) summary for the "AutoSure Voice Blood Glucose Monitoring System". However, it does not contain a detailed study report with acceptance criteria, sample sizes, ground truth establishment methods, or the performance data structured in table format as requested.

The document primarily focuses on:

Device Description: AutoSure Voice consists of a meter, test strips, and control solutions.
Intended Use: Quantitative measurement of glucose in fresh capillary whole blood from fingertips, forearm, or palm, for monitoring diabetes. It includes voice functionality for visually impaired users. Indicated for lay use and clinical settings.
Functional and Safety Testing: Mentions linearity testing (confirming no adverse effect of preset meter calibration code on accuracy or precision), verification of Lo/Hi display for out-of-range results, and software verification/validation.
Conclusion: The device modification does not adversely affect performance and is substantially equivalent to the predicate device (GlucoSure Voice BGM System).
FDA Determination Letter: Confirms substantial equivalence based on the provided information.

Therefore, I cannot fulfill most of the request based solely on the provided text, as the specific study details needed are absent.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in a quantitative manner in the provided text. The general statement is "linearity testing confirmed that the use of a preset meter calibration code did not have an adverse effect on accuracy or precision."
Reported Device Performance: No specific quantitative performance data (e.g., accuracy, precision, bias values, agreement percentages) are provided in the text.

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

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

Not mentioned. For blood glucose meters, the "ground truth" is typically a laboratory reference method (e.g., YSI glucose analyzer), not expert consensus.

4. Adjudication method for the test set

Not applicable as the text does not describe an adjudication process for this type of device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, this type of study is not relevant for a blood glucose monitoring system, which is a standalone device for quantitative measurements.

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

The device itself is a standalone system for measuring blood glucose. The "Functional and Safety Testing" section describes some performance characteristics (linearity, out-of-range detection, software verification), which would relate to its standalone performance, but no detailed study results are given.

7. The type of ground truth used

While not explicitly stated, for blood glucose meters, the ground truth is universally established by a laboratory reference method (e.g., a YSI glucose analyzer) to which the device's results are compared for accuracy. The text mentions "plasma-calibrated for easy comparison to lab result," which indirectly references a laboratory standard.

8. The sample size for the training set

Not mentioned. This device likely does not use a "training set" in the context of machine learning algorithms in the same way an AI-driven image analysis system would. Its "training" would involve calibration and validation during manufacturing.

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

Not mentioned. As above, the concept of a "training set" with ground truth in this context is likely different from AI/ML applications. The device's calibration would be established against reference methods.

Summary

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APR 0 9 2009

5 510(k) Summary

Submitter:	Thomas Y.S. Shen, Chairman & CEOApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078, CHINA (TAIWAN)
Contact Person:	Thomas Y.S. Shen, Chairman & CEOApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078, CHINA (TAIWAN)email: tyshen@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302
Date Prepared:	December 31, 2008
Trade Name:	AutoSure Voice Blood Glucose Monitoring System
Classification:	Glucose test system, 21 CFR 862.1345, Class II
Product Codes:	CGA, NBW, JJX
Predicate Device:	GlucoSure Voice BGM System
DeviceDescription:	AutoSure Voice 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 AutoSure Voice Blood Glucose Monitoring System is intendedfor the quantitative measurement of glucose in fresh capillarywhole blood samples drawn from the fingertips, forearm, or palm.Testing is done outside the body ( In Vitro diagnostic use). Themeter includes voice functionality to assist visually impaired users.It is indicated for both lay use by people with diabetes and in aclinical setting by healthcare professionals, as an aid to monitoringlevels in Diabetes Mellitus.
Functional andSafety Testing:	Linearity testing confirmed that the use of a preset metercalibration code did not have an adverse effect on accuracy orprecision. The ability to detect results below and above thereportable range and to display Lo and Hi, respectively, wasverified. Software verification and validation demonstrated thatmodifications did not lead to software defects in system function.
Conclusion:	The modification to the original device does not adversely affectperformance and the modified device is substantially equivalent tothe unmodified predicate device.

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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 0 9 2009

Apex BioTechnology Corporation c/o Thomas Y.S. Shen No.7, Li-Hsin Road V Hsinchu Science Park Hsinshu, China (Taiwan) 30078

Re: K090043 Trade Name: AutoSure Voice 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: March 10, 2009 Received: March 13, 2009

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 (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

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4. Indications for Use Statement

510(k) Number (if known): K090043

Device Name: AutoSure Voice Blood Glucose Monitoring System

Indications For Use:

AutoSure Voice Blood Glucose Monitoring System:

AutoSure Voice Test Strips:

Prescription Use 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)

Carol Benam
Sign-Off

ැ of In Vitro Diagnostic Device tion and Safet

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.