# K983178: Coamatic Heparin

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Nov 3, 1998 after 53 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: 2 generations back to K935212 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980242: IL Test Heparin, Instrumentation Laboratory CO (1998) Summary page 1.

## Most influential descendants
- K162540: INNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator, INNOVANCE (r) Heparin UF and Heparin LMW Controls (2017), 0 descendants of its own

## Indications for use
Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods. The amount of UFH or LMWH is determined from the anti-FXa activity expressed by the [AT*Heparin] complex formed in plasma. Heparin is the most frequently used antithrombotic drug. The biological activity of this sulphated glycosaminoglycan resides in its ability to accelerate (up to 2000-fold) the inhibitory effect of antithrombin on coagulation proteases.

Source page: https://510kreport.com/device/K983178
Methodology: https://510kreport.com/methodology