# K963676: Precision G Blood Glucose Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Medisense, Inc.
- Decided: Feb 20, 1997 after 160 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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: 2 generations back to K945887 (1995). 5 ancestors in all.
60 later devices descend from it; 3 cite it directly.
3 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944195: Quickpro Blood Glucose Testing System, Medisense, Inc. (1995) Summary page 1.
- K945887: Precision Q I D Blood Glucose Test Strips, Medisense, Inc. (1995) Summary page 1.
- K962295: Precision Qid Blood Glucose Test Strip, Medisense, Inc. (1996) Summary page 1.
- K896951: Satellite G Blood Glucose Monitoring System, Medisense, Inc. (1990) Summary page 1.

## Most influential descendants
- K971812: Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip (1997), 59 descendants of its own
- K983504: Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST (1999), 40 descendants of its own
- K052980: Liberty Glucose Control, Model 2120031 (2005), 19 descendants of its own
- K040814: Modification to Precision Xtra Advanced Diabetes Management System (2004), 16 descendants of its own
- K982303: Precision PCX Point of Care Management System  , QC Manager Data Manager System, Precision G Plus Blood Glucose Test ST (1998), 14 descendants of its own

## Indications for use
The Precision G Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh whole blood. The Precision G Blood Glucose Testing System is intended for home or professional use. The product may also be used by healthcare professionals for quantitative measurement of glucose in venous or arterial whole blood, provided the sample is used within 15 minutes.

Source page: https://510kreport.com/device/K963676
Methodology: https://510kreport.com/methodology