# K040814: Modification to Precision Xtra Advanced Diabetes Management System

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Apr 15, 2004 after 16 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 3 (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.
16 later devices descend from it; 3 cite it directly.
1 of 28 devices in its family (counting itself) has 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.

## Most influential descendants
- K091547: Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos (2010), 10 descendants of its own
- K080960: Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models BGMS:70900-03, 70090-02, G3CH Strips (2008), 3 descendants of its own
- K161738: FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems (2016), 2 descendants of its own
- K130094: Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System (2013), 2 descendants of its own
- K170463: KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System (2018), 1 descendant of its own

## Recalls of this device
- Nov 14, 2019 · Class II · Z-1556-2020: Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple
- 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 Xtra Advanced Diabetes Management 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 Xtra is also intended for the quantitative measurement of f3-hydroxybutyrate (f3-ketone) in fresh capillary whole blood. The Precision Xtra system is indicated for home (lay user) or professional use in the management of Patients with diabetes. The Precision Xtra System may also be used 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/K040814
Methodology: https://510kreport.com/methodology