# K053111: Sta-Cephascreen Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago, Inc.
- Decided: May 4, 2006 after 181 days
- Product code: GFO (Activated Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- 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 K792048 (1979). 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)
- K792048: Lancer Coagent Aptt Kit, Sherwood Medical Co. (1979) Summary page 1.

## Indications for use
The STA ® - Cephascreen® kits provide reagents for the determination of the activated partial thromboplastin time (APTT) in citrated plasma on the STA®line of analyzers suitable to these reagents.

Source page: https://510kreport.com/device/K053111
Methodology: https://510kreport.com/methodology