# K141656: Gmate Mini Blood Glucose Monitoring System, Gmate Step Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Philosys, Inc.
- Decided: Oct 2, 2015 after 469 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K024194 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color), I-Sens, Inc. (2009) Summary page 6.

## Indications for use
The Gmate® mini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf. The Gmate® mini Blood Glucose Monitoring System is intended to be used by a single person and should not be shared with any other person. The Gmate® mini Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of their diabetes management. The Gmate® mini Blood Glucose Monitoring System is NOT intended for the diagnosis or screening of diabetes or for neonatal use. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly). The Gmate® Blood Glucose Test Strips are for use with the Gmate® mini Blood Glucose Monitoring System only for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf. The Gmate® STEP Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf. The Gmate® STEP Blood Glucose Monitoring System is intended to be used by a single person and should not be shared with any other person. The Gmate® STEP Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of their diabetes management. The Gmate® STEP Blood Glucose Monitoring System is NOT intended for the diagnosis or screening of diabetes or for neonatal use. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly). The Gmate® STEP includes a pedometer feature that allows the user to count the number of steps they take. The Gmate® Blood Glucose Test Strips are for use with the Gmate® STEP Blood Glucose Monitoring System only for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.

Source page: https://510kreport.com/device/K141656
Methodology: https://510kreport.com/methodology