# K012975: Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision Control Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 28, 2002 after 176 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: 5 generations back to K945887 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 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.
- K982076: Amira Medical Atlast Blood Glucose Monitoring System, Amira Medical, Inc. (1998) Summary page 1.
- K992684: Freestyle Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2000) Summary page 1.

## Indications for use
The Sof-Tact Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Sof-Tact System is for home (lay user) use. The Sof-Tact Diabetes Management System is specifically intended for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the base of the thumb.

Source page: https://510kreport.com/device/K012975
Methodology: https://510kreport.com/methodology