# K982303: Precision PCX Point of Care Management System  , QC Manager Data Manager System, Precision G Plus Blood Glucose Test ST

- Pathway: 510(k) (Traditional)
- Applicant: Medisense, Inc.
- Decided: Dec 8, 1998 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: 4 generations back to K945887 (1995). 9 ancestors in all.
14 later devices descend from it; 1 cites it directly.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963676: Precision G Blood Glucose Testing System, Medisense, Inc. (1997) Summary page 1.
- 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.
- K971812: Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip, Medisense, Inc. (1997) Summary page 1.
- K970556: Surestep Pro Blood Glucose Monitoring System, Lifescan, Inc. (1997) Summary page 1.

## Most influential descendants
- K022941: Medisense Precision PCX Point of Care Management System for Blood Glucose Testing (2002), 13 descendants of its own
- K050500: Freestyle 600 Blood Glucose Monitoring System (2005), 12 descendants of its own
- K051839: Free-Style Freedom Blood Glucose Monitoring System, Model 11001 (2006), 10 descendants of its own
- K092638: Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23 (2010), 4 descendants of its own
- K070850: Freestyle Lite Blood Glucose Monitoring System (2007), 4 descendants of its own

## Indications for use
The Precision G Plus Point of Care Management System for Blood Glucose is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision'G Plus Point of Care Management System is for home (lay user) or professional use. The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial or neonatal whole blood, provided the sample is used within 30 minutes.

Source page: https://510kreport.com/device/K982303
Methodology: https://510kreport.com/methodology