# K981817: Coamatic Plasmin Inhibitor

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 28, 1998 after 129 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- 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 K833890 (1984). 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)
- K833890: Coatest Antiplasmin, Kabivitrum, Inc. (1984) Summary page 1.

## Indications for use
Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods. Plasmin inhibitor, the major fast-acting inhibitor of the fibrinolytic system, also know as o,-antiplasmin, is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes.

Source page: https://510kreport.com/device/K981817
Methodology: https://510kreport.com/methodology