# K954625: Prothrombin Time Test Card

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Diagnostics, Inc.
- Decided: Mar 11, 1996 after 166 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- 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 K882456 (1988). 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)
- K882456: Coag-I PT Test Card, Cardiovascular Diagnostic Services (1988) Summary page 1.

## Indications for use
The new TAS PT test card, as the existing marketed TAS PT test card made with rabbit brain thromboplastin, is intended to be used with the TAS Analyzer to determine the prothrombin time in citrated whole blood or plasma.

Source page: https://510kreport.com/device/K954625
Methodology: https://510kreport.com/methodology