# K051030: Coag-a-Mate MTX Iii

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Dec 23, 2005 after 245 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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 K813564 (1982). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962857: Coag-a-Mate MTX, Organon Teknika Corp. (1997) Summary page 1.
- K924453: Multi-Channel Discrete Analyzer (Mda-180), Organon Teknika Corp. (1992) Summary page 1.

## Indications for use
This is a multipurpose system for in vitro diagnostic coagulation studies and capable of performing clotting, chromogenic, and immunoassays.

Source page: https://510kreport.com/device/K051030
Methodology: https://510kreport.com/methodology