# K033845: Precision Xceed Diabetes Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Jan 8, 2004 after 28 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945887 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983504: Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST, Medisense, Inc. (1999) Summary page 1.

## Recalls of this device
- Aug 2, 2007 · Not classified · Z-0112-2008: Damage could lead to no display. Meters manufactured after January 31, 2007 could exhibit meter display damage if dropped on a hard surface. These meters could exhibit unreadable lot number fields and
- Mar 5, 2007 · Not classified · Z-0856-2007: The front button covers may detach from the meter.

## Indications for use
The Precision Xceed Diabetes Monitoring System is intended for in vitro diagnostic use (i.e. external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision Xceed is also intended for the quantitative measurement of I5-hydroxybutyrate (P-ketone) in fresh capillary whole blood. The Precision Xceed system is indicated for home (lay user) or professional use.

Source page: https://510kreport.com/device/K033845
Methodology: https://510kreport.com/methodology