# K760318: Actin, Activated Cephaloplastin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Dade, Baxter Travenol Diagnostics, Inc.
- Decided: Aug 3, 1976 after 8 days
- Product code: GFO (Activated Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- 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.
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
- K014028: Careside Aptt (2002), 0 descendants of its own

## Recalls of this device
- Mar 25, 2015 · Class II · Z-1703-2015: Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples with recoveries close to 

Source page: https://510kreport.com/device/K760318
Methodology: https://510kreport.com/methodology