DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM

K130244 · Delbio Incorporation · NBW · Aug 23, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130244
• Device Name: DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Delbio Incorporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

DiaTrue Plus Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample from the fingertip and the palm. The alternate site testing can be only used during steady-state blood glucose monitoring. The DiaTrue Plus Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an ald in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates. The DiaTrue Plus Blood Glucose Test Strips are used with the DiaTrue Plus Glucose meter to quantitativeiy measure glucose in fresh capillary whole blood samples drawn from the fingertip and the palm. The DiaTrue Glucose Control Solutions are for use with the DiaTrue Plus Blood Glucose Test Strips and the DiaTrue Plus Glucose meter as a quality control check that the meter and test strip are working together properly, and that the test is performing correctly. The DiaLife Mini Blood Gluçose Management Software is designed for use in the home with the DiaTrue Plus Blood Glucose Monitoring System to allow users to transmit data from meter to their computer. It is an optional data management software accessory for use with the DiaTrue Plus Blood Glucose Monitoring System.

Device Story

DiaTrue Plus Blood Glucose Monitoring System measures capillary whole blood glucose via amperometric electrochemical biosensor technology. System components: glucose meter, test strips, control solutions, and DiaLife Mini data management software. User applies blood sample to test strip; meter measures electrical current generated by glucose oxidase reaction; displays glucose concentration. Software allows data transmission from meter to PC via USB cable. Intended for single-patient home use; operated by patient. Output aids monitoring of diabetes control program. Modifications from predicate include addition of palm site sampling, extended storage conditions, and data management software/USB connectivity.

Clinical Evidence

Method comparison study (n=120) compared palm testing to YSI clinical chemistry analyzer; 100% of samples <75 mg/dL were within ±15 mg/dL, and 97% of samples ≥75 mg/dL were within ±20%. User performance study (n=150) confirmed accuracy for self-testing on palm; 100% of samples <75 mg/dL within ±15 mg/dL, 96.2% of samples ≥75 mg/dL within ±20%. Bench testing validated software data transfer accuracy.

Technological Characteristics

System includes glucose meter, test strips, and control solutions. Employs in vitro diagnostic electrochemical sensing for glucose quantification. Includes optional PC-based data management software. Intended for single-patient use.

Indications for Use

Indicated for single-person home use for quantitative measurement of glucose in fresh capillary whole blood from fingertip or palm. Not for diabetes diagnosis/screening, neonates, critically ill, dehydrated, shock, or hyperosmolar patients. AST only during steady-state glucose levels; not for CGM calibration or insulin dosing.

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 shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshin: Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 23, 2013

DELBio Incorporation C/O Nicky Pan 3F, 6F, No. 252, Shangying Road, Guishan Industrial Zone Taoyuan County 33341, Taiwan, R.O.C.

Re: K130244

Trade/Device Name: DiaTrue Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system . Regulatory Class: II Product Code: NBW, CGA, JJX, JQP Dated: July 02, 2013 Reccived: July 5, 2013

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. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/About/DA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for

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Page 2—Nicky Pan

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21)For, Prac 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/Reportal?roblem/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/MedicalDeviecs/ResourcesforYou/Industry/default.htm.

Sincercly yours,

## Carol C. Benson -S for

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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## Indications for Use

510(k) Number (if known): K130244

Device Name: DiaTrue Plus Blood Glucose Monitoring System

Indications for Use:

DiaTrue Plus Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample from the fingertip and the palm. The alternate site testing can be only used during steady-state blood glucose monitoring. The DiaTrue Plus Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an ald in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The DiaTrue Plus Blood Glucose Test Strips are used with the DiaTrue Plus Glucose meter to quantitativeiy measure glucose in fresh capillary whole blood samples drawn from the fingertip and the palm.

The DiaTrue Glucose Control Solutions are for use with the DiaTrue Plus Blood Glucose Test Strips and the DiaTrue Plus Glucose meter as a quality control check that the meter and test strip are working together properly, and that the test is performing correctly.

The DiaLife Mini Blood Gluçose Management Software is designed for use in the home with the DiaTrue Plus Blood Glucose Monitoring System to allow users to transmit data from meter to their computer. It is an optional data management software accessory for use with the DiaTrue Plus Blood Glucose Monitoring System.

Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

## Katherine Serrano -S

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

510(k) k130244