# K991065: Careside PT

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Jul 26, 1999 after 117 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: 2 generations back to K891169 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974343: Dade Innovin, Dade Intl., Inc. (1998) Summary page 1.
- K884863: Electra 900C Automatic Coagulation Timer, Medical Laboratory Automation Systems, Inc. (1989) Summary page 1.

## Indications for use
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure prothrombin time from applied citrated whole blood or citrated plasma as a general screening procedure for the detection of possible clotting deficiencies in the extrinsic pathway or to monitor patients receiving anticoagulant therapy.

Source page: https://510kreport.com/device/K991065
Methodology: https://510kreport.com/methodology