# K991101: Coag-a-Mate Max

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Jun 1, 1999 after 61 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Organon Teknika MDA-180: named in the summary without a submission number
- (no number) Organon Teknika Coag-A-Mate MTX: named in the summary without a submission number

## Indications for use
The Coag-A-Mate MAX is a fully automated coagulation system with the capability of performing coagulation assays that utilize photo-optical end point detection methodology. These assays include Screening Assays such as PT, APTT, and TT; Quantitative Clot Based Assays such as Factor VIII and Factor X, Clauss Fibrinogen and Derived PT Fibrinogen; and Colorimetric Assay such as ATIII and Heparin Xa.

Source page: https://510kreport.com/device/K991101
Methodology: https://510kreport.com/methodology