AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM

K131750 · Apex BioTechnology Corp. · CGA · Mar 6, 2014 · Clinical Chemistry

Device Facts

• Record ID: K131750
• Device Name: AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Mar 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AutoSure HT 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. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). 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. The AutoSure HT Blood Glucose Test Strips are to be used with the AutoSure HT Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The Contrex Plus 4 glucose control solution is used with the AutoSure HT meter and AutoSure HT test strips to verify that the meter and test strips are working together properly and that the test is performing correctly.

Device Story

System measures glucose in fresh capillary whole blood (fingertip, palm, forearm). User applies blood to test strip; meter uses electrochemical sensing to quantify glucose. Features hematocrit compensation via modified test strip (second blood channel) and augmented meter software. Designed for single-patient, home-use by people with diabetes. Results displayed on meter screen to aid in diabetes management. Quality control verified using Contrex Plus 4 control solutions.

Clinical Evidence

Clinical accuracy study conducted by healthcare professionals using finger, palm, and forearm sites. User performance study conducted with home users evaluating ease of use and manual comprehension. Results demonstrate substantial equivalence to predicate system.

Technological Characteristics

Electrochemical glucose monitoring system. Test strips utilize glucose oxidase chemistry with electron shuttle. Features hematocrit compensation via dual-channel strip design and 8 calibration codes. Meter software augmented for hematocrit compensation. System includes meter, test strips, and control solutions.

Indications for Use

Indicated for lay use by people with diabetes to monitor blood glucose levels in capillary whole blood (fingertip, palm, forearm). Not for neonatal use, diabetes screening/diagnosis, or critically ill patients (shock, severe hypotension/dehydration, hyperglycemia with hyperosmolarity). Not for use on patients with hematocrit outside 10-70%.

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

• GAL-1A Blood Glucose Monitoring System (k113208)
• Contrex Plus III Glucose Control Solutions (k113098)

Submission Summary (Full Text)

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K131750

# 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>email: [e-mail]<br>Phone: [phone]<br>FAX: [phone] |
| Date Prepared: | February 17, 2014 |
| Trade Names: | AutoSure HT Blood Glucose Monitoring System<br>AutoSure HT Blood Glucose Test Strips<br>Contrex Plus 4 Glucose Control Solutions |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II<br>Single (specified) analyte controls (assayed and unassayed), Class I, 21<br>CFR 862.1660 |
| Product Codes: | CGA, NBW; JJX |
| Predicate Devices: | GAL-1A Blood Glucose Monitoring System (k113208)<br>Contrex Plus III Glucose Control Solutions (k113098) |
| Device Description: | The AutoSure HT blood glucose meter and AutoSure HT test strips are<br>used for testing of blood glucose. Contrex Plus 4 Glucose Control<br>Solutions are used for quality control testing of the systems. |
| Intended Use: | AutoSure HT Blood Glucose Monitoring System<br>The AutoSure HT Blood Glucose Monitoring System is intended for the<br>quantitative measurement of glucose in fresh capillary whole blood samples<br>drawn from the fingertips, forearm, or palm. Alternative site testing should<br>be performed only during steady-state (when glucose is not changing<br>rapidly). Testing is done outside the body (In Vitro diagnostic use). It is<br>indicated for lay use by people with diabetes, as an aid to monitoring levels<br>in Diabetes Mellitus and should only be used by a single patient and it should<br>not be shared. It is not indicated for the diagnosis or screening of diabetes or<br>for neonatal use.<br><br>AutoSure HT Blood Glucose Test Strips<br>The AutoSure HT Blood Glucose Test Strips are to be used with the AutoSure<br>HT Blood Glucose Meter to quantitatively measure glucose in capillary whole<br>blood taken from fingertips, palm, or forearm.<br><br>Contrex Plus 4 Glucose Control Solutions<br>The Contrex Plus 4 glucose control solution is used with the AutoSure HT<br>meter and AutoSure HT test strips to verify that the meter and test strips are<br>working together properly and that the test is performing correctly. |
| Comparison of<br>Technological<br>Characteristics: | The AutoSure HT meter has been modified relative to the predicate by minor<br>changes in external design and modifications of the test strip holder to<br>support the hematocrit compensation feature. Meter software has been<br>augmented to support the hematocrit compensation feature. The AutoSure<br>HT test strip has been modified relative to the predicate by minor changes in<br>chemistry [17% increase in glucose oxidase, 6% increase in electron shuttle],<br>alteration of electrode tracks to support 8 calibration codes, and addition of a<br>second blood channel to support the hematocrit compensation feature. The<br>chemistry of the Contrex Plus 4 control solutions has been modified slightly<br>to increase viscosity. |
| Non-Clinical<br>Testing: | Testing was conducted as follows: EMC and Electrical Safety, test strip<br>holder reliability testing, battery life verification, drop testing, disinfection<br>performance (robustness of meter to multiple cleanings and disinfections),<br>software verification and validation, and linearity testing with validation of<br>Lo/Hi detection, temperature and humidity testing, sample volume<br>verification, precision testing, interferences testing, altitude testing,<br>qualification of control solutions, hematocrit performance testing,<br>Disinfection testing with recommended disinfectant wipes was done using an<br>animal virus test model. Results demonstrate substantial equivalence to the<br>predicate system. |
| Clinical Testing | An accuracy study was conducted with blood testing at finger, palm, and<br>forearm sites by healthcare professionals. A User Performance study was<br>conducted with self-testing at finger, palm, and forearm sites by home users,<br>including evaluation of ease of use and ease of understanding of the user<br>manual. Results demonstrate substantial equivalence to the predicate system. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the AutoSure HT system<br>performs in a substantially equivalent manner to that of the predicate. We<br>conclude that the AutoSure HT system is substantially equivalent to the<br>predicate system. |

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# 510(k) Summary (Continued)

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# 510(k) Summary (Continued)

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Image /page/3/Picture/0 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem with a stylized caduceus-like symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Centrol Center - WO66-G609
Silver Spring, MD 20993-0002 March 6, 2014

APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE,MANAGER, QA NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU 30078, CHINA (TAIWAN)

Trade/Device Name: AutoSure HT Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, NBW, JJX Dated: January 24, 2014 Received: January 28, 2014

### Dear Ms. Lee:

Re: K131750

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Lee

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

CourtneyH.Lias-S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## : . . . Indications for Use

510(k) Number (if known) k131750

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Device Name

AutoSure HT Blood Glucose Monitoring System

Indications for Use (Describe)

The AutoSure HT Blood Glucose Monitoring System is intended for the quanitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). 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.

The AutoSure HT Blood Glucose Test Strips are to be used with the AutoSure HT Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

The Contrex Plus 4 glucose control solution is used with the AutoSure HT test strips to verify that the meter and test strips are working together properly and that the test is performing correctly.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

[x] Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,

#### FOR FDA USE ONLY · .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.