# K092170: Sta Liatest Free PS

- Pathway: 510(k) (Special)
- Applicant: Diagnostica Stago, Inc.
- Decided: Dec 22, 2009 after 154 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010963 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010963: Sta-Liatest Free Protein S Test Kit, Diagnostica Stago, Inc. (2001) Summary page 1.

## Indications for use
The STA® - Liatest® Free PS kits are intended for use with analyzers of the STA® line suitable with these reagents for the antigenic assay of free Protein S in plasma by the immuno-turbidimetric method.

Source page: https://510kreport.com/device/K092170
Methodology: https://510kreport.com/methodology