# K992957: Advanced D-Dimer

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 28, 2000 after 148 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 K862156 (1986). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862156: Asserachrom D-DI Kit, American Bioproducts Co. (1986) Summary page 1.

## Most influential descendants
- K081732: Innovance D-Dimer and Innovance D-Dimer Controls (2008), 0 descendants of its own
- K041438: Advanced D-Dimer Assay (2004), 0 descendants of its own

## Indications for use
Advanced D-Dimer is a latex-enhanced turbidimetric test for the quantitative measurement of cross-linked fibrin degradation products containing D-dimer in human plasma, and aids in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).

Source page: https://510kreport.com/device/K992957
Methodology: https://510kreport.com/methodology