# K913424: Staclot (R) Protein S Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Oct 8, 1991 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K082631: Thrombo Tek Pse, Model 90-480 (2008), 0 descendants of its own
- K043571: Cryocheck Clot S (2005), 0 descendants of its own
- K022290: Protein S AC (2002), 0 descendants of its own

## Recalls of this device
- Jul 29, 2026 · Class II · Z-3047-2026: A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified

Source page: https://510kreport.com/device/K913424
Methodology: https://510kreport.com/methodology