The TRUE METRIX Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single patient and should not be shared. The TRUE METRIX Self Monitoring Blood Glucose System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Device Story
TRUE METRIX Self Monitoring Blood Glucose System; measures glucose in capillary whole blood; intended for single-patient home use. Modification involves software update to error code messaging: glucose levels >900 mg/dL now trigger 'EHi' error instead of 'E-5'. Device includes meter and test strips; user performs finger/forearm stick; meter provides digital glucose readout. Modification does not alter fundamental scientific technology; labeling updated to reflect new error code and user actions. System validated for 5-year use with PDI Super Sani-Cloth wipes for disinfection.
Clinical Evidence
No new clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of software modifications. Previous disinfection efficacy and robustness studies (K120989) support 5-year single-patient use.
Technological Characteristics
Glucose test system (21 CFR 862.1345). Amperometric sensing technology. Software-controlled error messaging. Validated for 10,950 cleaning/disinfection cycles using PDI Super Sani-Cloth wipes. No change to fundamental scientific technology.
Indications for Use
Indicated for single-patient, home-use quantitative glucose measurement in fresh capillary whole blood (fingertip or forearm) for diabetes management. Not for neonates, diagnosis, or screening.
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
TRUE METRIX Self Monitoring Blood Glucose Meter (K140100)
Reference Devices
TRUE METRIX Self Monitoring Blood Glucose Meter (K120989)
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
# I Background Information:
A 510(k) Number
K262116
B Applicant
Trividia Health, Inc.
C Proprietary and Established Names
TRUE METRIX Self Monitoring Blood Glucose System
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBW | Class II | 21 CFR 862.1345 - Glucose Test System | CH - Clinical Chemistry |
# II Review Summary:
This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.
1. The name and 510(k) number of the SUBMITTER'S previously cleared device: TRUE METRIX Self Monitoring Blood Glucose Meter (K140100).
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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a. The reassignment of test strip error conditions caused by very high glucose levels (>900 mg/dL) from the “E-5” error code to the new “EHi” error code.
b. Updated device labeling to reflect the software modifications to the error code messaging and appropriate actions to be taken by the user.
4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.
The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.
The device system is intended for single patient use only. Disinfection efficacy studies were previously performed on the exterior meter materials (K120989) demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant PDI Super Sani-Cloth wipes (EPA Reg. No.: 9480-4). A robustness study was also previously performed by the sponsor demonstrating that there was no change in performance or in external materials of the meter after 10,950 cleaning and disinfection cycles to support 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.
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