The AutoSure Voice II Plus 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. 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 and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

AutoSure Plus Blood Glucose Test Strips:

The AutoSure Plus Blood Glucose Test Strips are to be used with the AutoSure Voice II Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

Contrex Plus III Glucose Control Solutions:

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

The AutoSure Voice II Plus blood glucose meter and AutoSure Plus blood glucose test strips are used for testing of blood glucose by self-testers at home with Contrex Plus III Glucose Control Solutions for quality control testing.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the AutoSure Voice II Plus Blood Glucose Monitoring System, based on the provided 510(k) summary:

This device is a blood glucose monitoring system, and as such, its performance is primarily evaluated based on its accuracy in measuring glucose concentrations. The summary describes a "substantial equivalence" determination to a predicate device (AutoSure Voice II Blood Glucose Monitoring System, K102037). While specific numerical acceptance criteria (e.g., percentage within a certain deviation from a reference method) are not explicitly detailed in the provided text, the conclusion of "substantial equivalence" implies that the new device met the expected performance standards for blood glucose meters during non-clinical and clinical testing.

A key aspect for blood glucose meters is meeting ISO standards or FDA guidance for accuracy, which typically specifies a high percentage of results falling within specific error margins when compared to a laboratory reference method. The summary states that "Results demonstrate substantial equivalence to the predicate device meter, test strips, and control solutions" for non-clinical testing and "Results demonstrate substantial equivalence to the predicate system" for clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria and precise performance metrics (e.g., specific bias, percentage within error margins) are not explicitly quantified in the provided 510(k) summary for the new device, a direct table of numerical "acceptance criteria" vs. "reported performance" cannot be fully constructed for this specific device.

However, based on the context of blood glucose meter approvals, the implied acceptance criteria would be that the device's performance is comparable to or better than the predicate device and meets established regulatory guidance for accuracy. The reported performance is that this equivalence was met.

Acceptance Criteria (Implied for Glucose Meters)	Reported Device Performance
Substantial equivalence to predicate device regarding precision, analytical specificity (interferences), linearity, Lo/Hi detection, minimum sample volume, altitude, hematocrit, humidity and temperature, and control solution qualification.	Demonstrated substantial equivalence to the predicate device meter, test strips, and control solutions.
Substantial equivalence to predicate system in clinical accuracy for healthcare professional use.	Demonstrated substantial equivalence to the predicate system.
Substantial equivalence to predicate system in user performance (self-testing at finger, palm, and forearm sites).	Demonstrated substantial equivalence to the predicate system.

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

Test Set Sample Size: The summary does not explicitly state the sample sizes for the clinical accuracy study (healthcare professionals) or the user performance study (self-testing).
Data Provenance: The submission originates from China (Taiwan). The studies are described as "Clinical Testing" and "User Performance study," indicating they are likely prospective data collection rather than retrospective, as they were conducted to support the submission of the new device.

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

Number of Experts: The summary mentions "blood testing by healthcare professionals" for the accuracy study. It does not specify the number of individual experts (e.g., laboratory technicians, nurses, or physicians) involved or their specific qualifications (e.g., years of experience as a radiologist). For blood glucose meters, the "ground truth" is typically established by comparative analysis against a laboratory reference method, often performed by trained laboratory personnel.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

The 510(k) summary does not provide any information regarding an adjudication method. For blood glucose meters, the ground truth is typically a direct comparison to a validated central laboratory method, so an adjudication process by multiple clinical experts (as might be seen in imaging studies) is not usually applicable in the same way.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret and classify images, and the AI's effect on reader performance is evaluated. This device is a blood glucose monitoring system, and its performance is assessed directly against a reference method and through user studies, not through human interpretation of complex data.

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

Yes, a standalone study was done, essentially. The "Non-Clinical Testing" section describes a series of analytical performance tests (precision, analytical specificity, linearity, etc.) that assess the device's inherent performance characteristics independent of user interaction, comparing it against established benchmarks or the predicate device. The "Clinical Testing" section involving "blood testing by healthcare professionals" also represents a form of standalone performance evaluation, as it assesses the device's accuracy when used by trained individuals, establishing its inherent measurement capability.

7. Type of Ground Truth Used

The ground truth for both non-clinical and clinical testing would have been established by laboratory reference methods for glucose measurement. For example, a YSI reference method is commonly used to determine the true glucose concentration in blood samples. The device's readings are then compared to these reference values.

8. Sample Size for the Training Set

Not Applicable / Not Provided. This device is a blood glucose meter, not a machine learning or AI-driven diagnostic imaging system that typically has a separate "training set" for model development. The device's calibration and analytical performance are based on its electrochemical design and manufacturing specifications, which are established through a different development and validation process than algorithmic training. The 510(k) summary does not mention any machine learning components that would require a "training set."

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

Not Applicable. As explained above, there is no mention or implication of a machine learning component requiring a "training set" in the context of this traditional medical device.

Summary

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K113098

JAN 1 7 2012

510(k) Summary
Submitter:	Apex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)
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:	January 10, 2012
Trade Names:	AutoSure Voice II Plus Blood Glucose Monitoring SystemAutoSure Plus Blood Glucose Test StripsContrex Plus III Glucose Control Solutions
Classification:	Glucose test system, 21 CFR 862.1345, Class IISingle (specified) analyte controls (assayed and unassayed), 21 CFR862.1660, Class I
Product Codes:	CGA, NBW, JJX
Predicate Device:	AutoSure Voice II Blood Glucose Monitoring System (K102037)
Device Description:	The AutoSure Voice II Plus blood glucose meter and AutoSure Plusblood glucose test strips are used for testing of blood glucose by self-testers at home with Contrex Plus III Glucose Control Solutions forquality control testing.
Intended Use:	AutoSure Voice II Plus Blood Glucose Monitoring System:
	The AutoSure Voice II Plus Blood Glucose Monitoring System is intended for thequantitative measurement of glucose in fresh capillary whole blood samples drawn
	from the fingertips, forearm, or palm. 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 singlepatient and it should not be shared. It is not indicated for the diagnosis or screening
	of diabetes or for neonatal use.

	AutoSure Plus Blood Glucose Test Strips:
	The AutoSure Plus Blood Glucose Test Strips are to be used with the AutoSureVoice II Plus Blood Glucose Meter to quantitatively measure glucose in capillary
	whole blood taken from fingertips, palm, or forearm. They are not indicated for the
	diagnosis or screening of diabetes or for neonatal use.
	Contrex Plus III Glucose Control Solutions:
	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.
Comparison of	The AutoSure Voice II Plus meter is identical to the predicate AutoSure Voice II
Technological	meter. The AutoSure Plus test strip is nearly identical to the predicate AutoSure
Characteristics:	test strip, differing only due to minor changes in chemistry and the size of thesample chamber and is exactly identical to the GAL-IC test strip (kI02816).
	The Contrex Plus III control solutions include a red dye not in the Contrex Plus
	predicate and the concentrations of the ingredients are slightly different. The
	Contrex Plus III control solutions in this submission are identical to the solutions
	cleared under K102816, and have now been qualified for usage with the newAutoSure Voice II Plus system.
Non-Clinical	Testing was conducted as follows:Precision, analytical specificity
Testing:	(interferences), linearity, Lo/Hi detection, minimum sample volume, altitude,
	hematocrit, humidity and temperature, control solution qualification, and
	environmental conditions testing.Results demonstrate substantialequivalence to the predicate device meter, test strips, and control solutions.
Clinical Testing	An accuracy study was performed with blood testing by healthcare
	professionals. A User Performance study was conducted with self-testing at
	finger, palm, and forearm sites. Results demonstrate substantial equivalence
	to the predicate system.
Conclusion:	Clinical and non-clinical testing demonstrated that the AutoSure VoiceII Plus system performs in a substantially equivalent manner to that of the
	predicate system. We conclude that the AutoSure Voice II Plus meter,
	AutoSure Plus test strips and Contrex Plus III control solutions are
	substantially equivalent to the predicate devices.

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510(k) Summary (Continued)

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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 other bird-like figure, with its wings spread and head facing to the left.

10903 New Hampshire Avenue Silver Spring, MD 20993

Apex BioTechnology Corporation c/o Hsue-mei Lee Manager of Quality Assurance Department No. 7 Li-Hsin Road V. Hsinchu Science Park Hsinchu, China (Taiwan) 30078

JAN 1 7 2012

Re: K113098 Trade Name: AutoSure Voice II Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 8862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. CGA. JJX Dated: December 13, 2011 Received: December 15, 2011

Dear Hsue-mei Lee:

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 CFK 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).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours.

Signature

Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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): K113098

Device Name: AutoSure Voice II Plus Blood Glucose Monitoring System

Indications for Use:

AutoSure Voice II Plus Blood Glucose Monitoring System:

AutoSure Plus Blood Glucose Test Strips:

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Ohmz

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

510(k) K113098

Page 1 of 2

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Indications for Use Statement

510(k) Number (if known): K113098

Device Name: Contrex Plus III Glucose Control Solutions

Indications for Use:

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Chris

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

510(k) K113098

Page 2 of 2

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.