# K080960: Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models BGMS:70900-03, 70090-02, G3CH Strips

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Sep 5, 2008 after 155 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: 6 generations back to K945887 (1995). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040814: Modification to Precision Xtra Advanced Diabetes Management System, Abbott Laboratories (2004) Summary page 1.

## Most influential descendants
- K130094: Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System (2013), 2 descendants of its own
- K132511: Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System (2013), 1 descendant of its own
- K153330: FreeStyle Precision Neo H Blood Glucose Monitoring System (2016), 0 descendants of its own

## Indications for use
The Precision Xceed Pro Blood Glucose and P-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (D-glucose) in fresh capillary whole blood (fingertip), and of O3-Ketone (beta - hydroxybutyrate) in fresh capillary whole blood samples. The Precision Xceed Pro System is for home (lay user) or professional use. The system is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the effectiveness of diabetes control programs. Healthcare professionals may also use the product for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.

Source page: https://510kreport.com/device/K080960
Methodology: https://510kreport.com/methodology