# K863594: Actin FSL Activated PTT Reagent

- Pathway: 510(k) (Traditional)
- Applicant: American Dade
- Decided: Oct 17, 1986 after 32 days
- Product code: GGW (Test, Time, Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K033471: Phospholin ES and Calcium Chloride (2004), 0 descendants of its own

## Recalls of this device
- Mar 11, 2013 · Class II · Z-1073-2013: Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
- Dec 19, 2011 · Not classified · Z-1043-2012: The listed lots of Dade(R) Actin(R) FSL Reagent show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.

Source page: https://510kreport.com/device/K863594
Methodology: https://510kreport.com/methodology