# K042687: Enzygnost F+2 (Monoclonal) Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 10, 2004 after 72 days
- Product code: MIF (Prothrombin Fragment 1.2)
- Device class: 2
- Regulation: 21 CFR 864.7320
- 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 K922934 (1992). 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)
- K922934: Enzygnost F 1+2, Behring Diagnostics, Inc. (1992) Summary page 1.

## Indications for use
Enzygnost F1 +2 (monoclonal) is an enzyme immunoassay for the quantitative determination of human prothrombin F1 +2 in plasma. Measurement of F1+2 is used as an aid in the diagnosis, monitoring, and evaluation of acquired or hereditary blood coagulation disorders. It is indicated as an aid in assessing risk of thrombosis and in monitoring efficacy of anticoagulant therapy.

Source page: https://510kreport.com/device/K042687
Methodology: https://510kreport.com/methodology