# K974776: Mda D-Dimer

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Apr 16, 1998 after 115 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- 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 K912876 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912876: Fibrinostika FBDP Microelisa System, Organon Teknika Corp. (1991) Summary page 1.
- K945642: Agen Dimertest Gold Eia, Agen Biomedical, Ltd. (1995) Summary page 1.

## Indications for use
MDA® D-Dimer is a homogeneous latex particle based immunoassay Lia) for the quantitative determination of cross-linked fibrin degradation products containing the D-dimer domain in citra uman plasma. The assay is designed for use on the MDA® 180 automated coagulation analyzer. D-dimer is elevated in disseminated intravascular coagulation {DIC), deep venous thrombosis (DVT), and pulmonary embolism.

Source page: https://510kreport.com/device/K974776
Methodology: https://510kreport.com/methodology