# K014028: Careside Aptt

- Pathway: 510(k) (Traditional)
- Applicant: Careside Hemotology, Inc.
- Decided: Feb 8, 2002 after 64 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 K760318 (1976). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884863: Electra 900C Automatic Coagulation Timer, Medical Laboratory Automation Systems, Inc. (1989) Summary page 1.
- K760318: Actin, Activated Cephaloplastin Reagent, Dade, Baxter Travenol Diagnostics, Inc. (1976) Summary page 1.

## Indications for use
For in vitro diagnostic use with the CARESIDE Analyzer to measure activated partial thromboplastin time from citrated whole blood or citrated plasma as an aid in the diagnosis of patients with clotting disorders and to monitor patients receiving heparin anticoagulation therapy.

Source page: https://510kreport.com/device/K014028
Methodology: https://510kreport.com/methodology