DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION

K103329 · Delbio Incorporation · NBW · Mar 13, 2012 · Clinical Chemistry

Device Facts

• Record ID: K103329
• Device Name: DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
• Applicant: Delbio Incorporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DiaTrue Plus Blood Glucose Monitoring System is an in vitro diagnostic medical device intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control and should not be shared. The device should not be used for screening or diagnosis of diabetes or for testing neonates. The DiaTrue Plus Blood Glucose Meter is intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body. It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control. The DiaTrue Plus Blood Glucose Test Strips are intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The Blood Glucose Test Strips must be used with the DiaTrue Plus Blood Glucose Meter. Testing is done outside the body. They are indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control. For use with DiaTrue Blood Glucose Meter and DiaTrue Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Three levels of control solution are provided: Level I, Level II and Level III.

Device Story

System measures glucose in capillary whole blood via electrochemical amperometry; uses glucose oxidase enzyme on test strips. User applies blood to strip; meter measures electrical current generated by glucose reaction; displays result in mg/dL. Intended for single-patient home use; requires manual code selection matching test strip vial. System includes meter, test strips, and three levels of control solution. Provides quantitative monitoring of diabetes control; does not transmit data. Benefits patient by enabling self-monitoring of blood glucose levels to manage diabetes.

Clinical Evidence

No clinical data provided in the document; substantial equivalence established via bench testing and performance verification.

Technological Characteristics

Electrochemical biosensor-based glucose monitoring system. Includes meter, test strips, and three-level control solutions. Standalone device for home use. Quantitative measurement of capillary whole blood glucose.

Indications for Use

Indicated for single-person home use by individuals with diabetes to monitor glucose levels in fresh capillary whole blood from fingertips. Contraindicated for screening or diagnosis of diabetes, testing neonates, critically ill patients, dehydrated patients, patients in shock, or hyperosmolar patients. Not for alternative site testing.

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.

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of three human figures connected at the head and flowing downward. The figures are arranged in a row, with each figure slightly offset from the others. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

DELBIO INCORPORATION c/o Nicky Pan 252 Shangying Road Guishan Industrial Zone Taoyuan County China (Taiwan) 33341

MAR 1 3 2012

Re: k103329

> Trade Name: DiaTrue Plus Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: March 7, 2012 Received: March 7, 2012

Dear Nicky Pan:

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).

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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 Tou may 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,

\$

S. Huling, Ph.D.

Courtney 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

510(k) Number (if known): K103329

# Device Name: DiaTrue Plus Blood Glucose Monitoring System

Indications for Use:

### DiaTrue Plus Blood Glucose Monitoring System:

The DiaTrue Plus Blood Glucose Monitoring System is an in vitro diagnostic medical device intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control and should not be shared. The device should not be used for screening or diagnosis of diabetes or for testing neonates.

### DiaTrue Plus Blood Glucose Meter:

The DiaTrue Plus Blood Glucose Meter is intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body. It is indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control.

## DiaTrue Plus Blood Glucose Test Strips:

The DiaTrue Plus Blood Glucose Test Strips are intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The Blood Glucose Test Strips must be used with the DiaTrue Plus Blood Glucose Meter. Testing is done outside the body. They are indicated for use at home and should only be used by a single person with diabetes as an aid to monitor the effectiveness of diabetes control.

# DiaTrue Glucose Control solution:

For use with DiaTrue Blood Glucose Meter and DiaTrue Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Three levels of control solution are provided: Level I, Level II and Level III.

Prescription Use AND/OR (21 CFR 801 Subpart C)

Over-The-Counter Use X (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Kith ( him Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)________________________________________________________________________________________________________________________________________________________________________