# K012386: Acticlot Protein S, Model 843L

- Pathway: 510(k) (Traditional)
- Applicant: American Diagnostica, Inc.
- Decided: Sep 14, 2001 after 49 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 K955738 (1996). 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)
- K955738: Bioclot Protein S, Medical Diagnostic Technologies, Inc. (1996) Summary page 1.

## Indications for use
The ACTICLOT® Protein S clotting assay is an in vitro diagnostic device intended for the quantitative determination of Protein S activity in human plasma. Protein S activity levels in plasma are known to be low in patients with congenital Protein S deficiencies type-I, type-Ila, and type-IIb, and may also be low in pregnant women, in patients with liver disease and in inflammatory disease in which levels of C4b binding protein are elevated. A decrease in Protein S activity is associated with an increased incidence of thromboembolism.

Source page: https://510kreport.com/device/K012386
Methodology: https://510kreport.com/methodology