AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III

K113098 · Apex BioTechnology Corp. · NBW · Jan 17, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113098
• Device Name: AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. 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 a fingertip, palm, or forearm. They are not indicated for the diagnosis or screening of diabetes or for neonatal use. 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 Story

System comprises blood glucose meter, test strips, and control solutions. Meter accepts capillary whole blood samples via test strips; performs quantitative glucose measurement. Includes voice functionality for visually impaired users. Used at home by patients for self-monitoring of diabetes. Healthcare providers use output to assess glycemic control. Control solutions validate system performance and user technique. Benefits include accessible, accurate, and convenient glucose monitoring for diabetes management.

Clinical Evidence

Bench testing only. Accuracy evaluated against YSI reference method using 145 capillary samples. Results showed 100% of samples within ±15 mg/dL (for <75 mg/dL) and 100% within ±20% (for ≥75 mg/dL). Lay-user study confirmed performance across fingertip, palm, and forearm sites. Robustness testing validated 5-year simulated use for cleaning/disinfection. Altitude, temperature, humidity, and hematocrit (30-55%) effects were within acceptable limits.

Technological Characteristics

Electrochemical biosensor; carbon electrodes; glucose oxidase enzyme. Dimensions: 93x58x21 mm; weight: 79g. Sample volume: 0.8 μL. Measurement range: 20-600 mg/dL. Connectivity: None (standalone). Power: Battery. Sterilization: N/A (non-sterile). Software: Embedded firmware with voice output functionality.

Indications for Use

Indicated for lay use by people with diabetes to monitor blood glucose levels using fresh capillary whole blood from fingertips, forearm, or palm. Not for diagnosis/screening of diabetes or neonatal use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• AutoSure Voice II Blood Glucose Monitoring System (k102037)

Submission Summary (Full Text)

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K113098

JAN 1 7 2012

| 510(k) Summary | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Apex BioTechnology Corp.<br>No. 7, Li-Hsin Road V, Hsinchu Science Park<br>Hsinchu, 30078<br>CHINA (TAIWAN) |
| Contact Person: | Hsue-mei Lee<br>Manager of Quality Assurance Department<br>Apex BioTechnology Corp.<br>No. 7, Li-Hsin Road V, Hsinchu Science Park<br>Hsinchu, 30078<br>CHINA (TAIWAN)<br><br>email: [e-mail]<br>Phone: [phone]<br>FAX: [phone] |
| Date Prepared: | January 10, 2012 |
| Trade Names: | AutoSure Voice II Plus Blood Glucose Monitoring System<br>AutoSure Plus Blood Glucose Test Strips<br>Contrex Plus III Glucose Control Solutions |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II<br>Single (specified) analyte controls (assayed and unassayed), 21 CFR<br>862.1660, 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 Plus<br>blood glucose test strips are used for testing of blood glucose by self-<br>testers at home with Contrex Plus III Glucose Control Solutions for<br>quality control testing. |
| Intended Use: | AutoSure Voice II Plus Blood Glucose Monitoring System: |
| | The AutoSure Voice II Plus Blood Glucose Monitoring System is intended for the<br>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<br>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<br>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.<br>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 the<br>sample 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 new<br>AutoSure Voice II Plus system. |
| Non-Clinical | Testing was conducted as follows:<br>Precision, analytical specificity |
| Testing: | (interferences), linearity, Lo/Hi detection, minimum sample volume, altitude, |
| | hematocrit, humidity and temperature, control solution qualification, and |
| | environmental conditions testing.<br>Results demonstrate substantial<br>equivalence 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 Voice<br>II 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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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 [phone]. 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 [phone]. 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 [phone] or [phone] 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:

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.

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

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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:

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.

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

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