# K010963: Sta-Liatest Free Protein S Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago, Inc.
- Decided: Jun 6, 2001 after 68 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K181525: INNOVANCE Free PS Ag (2018), 0 descendants of its own
- K092170: Sta Liatest Free PS (2009), 0 descendants of its own

## Recalls of this device
- Feb 4, 2026 · Class II · Z-1491-2026: The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.

Source page: https://510kreport.com/device/K010963
Methodology: https://510kreport.com/methodology