# K965076: Mda Heparin Anti-X Assay

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Mar 18, 1997 after 89 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 K925433 (1995). 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)
- K925433: The Stachrom Heparin Assay Kit, American Bioproducts Co. (1995) Summary page 1.

## Indications for use
MDA™ Heparin anti-Xₐ is a chromogenic assay for the quantitative determination of heparin anti-Xₐ activity in human plasma.

Source page: https://510kreport.com/device/K965076
Methodology: https://510kreport.com/methodology