# K013637: Actichrome Heparin (Anti-Fiia)

- Pathway: 510(k) (Traditional)
- Applicant: American Diagnostica, Inc.
- Decided: Apr 16, 2002 after 162 days
- Product code: KFF (Assay, Heparin)
- Device class: 2
- Regulation: 21 CFR 864.7525
- 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 K972209 (1997). 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)
- K972209: Spectrolyse Heparin (Anti-Iia), Medical Diagnostic Technologies, Inc. (1997) Summary page 1.

## Indications for use
ACTICHROME® Heparin (anti-flla) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor Ila (thrombin) inhibition. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K013637
Methodology: https://510kreport.com/methodology