# K923731: Staclot LA Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Dec 23, 1992 after 149 days
- Product code: GFO (Activated Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- Recalls of this device: 3 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K193556: Cryocheck Hex LA (2020), 0 descendants of its own

## Recalls of this device
- Nov 14, 2018 · Class II · Z-0611-2019: There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
- Nov 14, 2018 · Class II · Z-0610-2019: There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
- Jul 18, 2006 · Not classified · Z-1441-06: Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.

Source page: https://510kreport.com/device/K923731
Methodology: https://510kreport.com/methodology