# K193340: GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Microtech Medical, Inc.
- Decided: Sep 11, 2020 after 284 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 K002134 (2000). 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)
- K130284: ON Call Sharp Blood Glucose Monitoring System, ACON Laboratories, Inc. (2013) Summary page 6.

## Indications for use
GoChek Blood Glucose Monitoring System The GoChek Blood Glucose Monitoring System comprises of the GoChek Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Blood Glucose Monitoring System is intended for single-patient use and should not be shared. The GoChek Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes. GoChek Connect Blood Glucose Monitoring System The GoChek Connect Blood Glucose Monitoring System comprises of the GoChek Connect Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Connect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Connect Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Connect Blood Glucose Monitoring System is intended for single-patient use and should not be shared. The GoChek Connect Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Connect Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.

Source page: https://510kreport.com/device/K193340
Methodology: https://510kreport.com/methodology