# K022941: Medisense Precision PCX Point of Care Management System for Blood Glucose Testing

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 28, 2002 after 55 days
- Product code: LFR (Glucose Dehydrogenase, 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: 5 generations back to K945887 (1995). 10 ancestors in all.
13 later devices descend from it; 2 cite 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)
- K982303: Precision PCX Point of Care Management System  , QC Manager Data Manager System, Precision G Plus Blood Glucose Test ST, Medisense, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K112638: Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips (2012), 3 descendants of its own

## Indications for use
The MediSense Precision PCx 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 MediSense Precision PCx Point of Care Management System is for home (lay user) or professional use. The PCx Point of Care Management System for Blood Glucose Testing is for monitoring blood glucose concentration in patients with diabetes mellitus or other conditions. The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood, provided that the sample is used within 30 minutes.

Source page: https://510kreport.com/device/K022941
Methodology: https://510kreport.com/methodology