TRUE METRIX GO Self Monitoring Blood Glucose System

K143548 · Trividia Health, Inc. · NBW · Apr 1, 2016 · Clinical Chemistry

Device Facts

• Record ID: K143548
• Device Name: TRUE METRIX GO Self Monitoring Blood Glucose System
• Applicant: Trividia Health, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes, for neonatal use or for alternative site testing. The TRUE METRIX Self Monitoring Blood Glucose Test Strips are for use with the TRUE METRIX GO Self Monitoring Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

Device Story

True Metrix Go is a portable blood glucose monitoring system for home use by patients with diabetes. System consists of a meter and test strips. Patient applies a fresh capillary whole blood sample from the fingertip to the test strip; meter performs electrochemical measurement of glucose concentration. Output is a digital glucose reading displayed on the meter. Device aids patients in monitoring diabetes control effectiveness. Intended for single-person use; not for neonatal or alternative site testing.

Clinical Evidence

Clinical user performance study conducted with 108 subjects comparing lay user fingerstick results to YSI reference method. Results showed 100% of samples within ±15 mg/dL for glucose <75 mg/dL and 100% within ±20% for glucose ≥75 mg/dL. Bench testing included precision, linearity (R²=0.9987), interference, hematocrit (20-70%), and altitude (up to 10,200 ft) studies, all meeting acceptance criteria.

Technological Characteristics

Electrochemical glucose test system; utilizes test strips for quantitative measurement of capillary whole blood glucose. Portable meter form factor for home use.

Indications for Use

Indicated for people with diabetes for quantitative measurement of glucose in fresh capillary whole blood from the fingertip to monitor diabetes control. Not for diagnosis, screening, neonatal use, or alternative site testing. Intended for single-patient 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.

Submission Summary (Full Text)

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July 11, 2016

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

TRIVIDIA HEALTH, INC. ROBERTO CUNHA SENIOR MANAGER, GLOBAL REGULATORY AFFAIRS 2400 NW 55TH COURT FORT LAUDERDALE, FL 33309

Re: K143548

Trade/Device Name: True Metrix Go Self Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: March 21, 2016 Received: March 23, 2016

Dear Mr. Cunha:

This letter corrects our substantially equivalent letter of April 1, 2016.

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

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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 regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -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) k143548

Device Name

TRUE METRIX GO Self Monitoring Blood Glucose System

#### Indications for Use (Describe)

The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared.

The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

The TRUE METRIX GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes, for neonatal use or for alternative site testing.

The TRUE METRIX Self Monitoring Blood Glucose Test Strips are for use with the TRUE METRIX GO Self Monitoring Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 801 Subpart C)

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

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