# K983504: Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST

- Pathway: 510(k) (Traditional)
- Applicant: Medisense, Inc.
- Decided: Jul 9, 1999 after 276 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945887 (1995). 10 ancestors in all.
40 later devices descend from it; 6 cite it directly.
1 of 51 devices in its family (counting itself) has 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.
- 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.
- K911801: Ketosite (TM)/Stat-Site (TM)/Ketosite (TM) Low-HI Con, Gds Technology, LLC (1991) Summary page 1.
- K850368: Sigms B-Hydroxybutarate Procedure NO. 310-UV, Sigma Chemical Co. (1985) Summary page 1.

## Most influential descendants
- K052980: Liberty Glucose Control, Model 2120031 (2005), 19 descendants of its own
- K040814: Modification to Precision Xtra Advanced Diabetes Management System (2004), 16 descendants of its own
- 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
- K060706: Liberty Normal Glucose Control Solution (2006), 8 descendants of its own
- K070506: SMS Multi Glucose Control, Model 2120049 (2007), 5 descendants of its own

## Recalls of this device
- Nov 8, 2002 · Not classified · Z-0403-03: Use of glucose blood strips may provide false high results

## Indications for use
The Precision Xtra Advanced Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose and/or ketone in fresh capillary whole blood. The Precision Xtra System is for home (lay user) or professional use. 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/K983504
Methodology: https://510kreport.com/methodology