# K013318: Actichrome Heparin (Anti-Fxa), Model 832

- Pathway: 510(k) (Traditional)
- Applicant: American Diagnostica, Inc.
- Decided: Mar 8, 2002 after 154 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 K923499 (1994). 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)
- K923499: Spectrolyse Heparin Kit, Biopool AB (1994) Summary page 1.

## Indications for use
ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight hcpanns in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K013318
Methodology: https://510kreport.com/methodology