# K972696: IL Test D-Dimer

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Nov 4, 1997 after 109 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 K945642 (1995). 1 ancestor in all.
9 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945642: Agen Dimertest Gold Eia, Agen Biomedical, Ltd. (1995) Summary page 1.

## Most influential descendants
- K083518: Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls (2009), 2 descendants of its own
- K090264: Hemosil D-Dimer HS 500, Controls (2010), 1 descendant of its own
- K050278: Hemosil D-Dimer (2005), 1 descendant of its own
- K221359: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM (2023), 0 descendants of its own
- K172903: HemosIL D-Dimer HS 500 (2017), 0 descendants of its own

## Indications for use
IL Test™ D-Dimer permits the quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry. The IL Test™ D-Dimer Latex Reagent is a suspension of latex particles coated with a monoclonal antibody specific for the D-Dimer domain included in fibrin soluble derivatives. When plasma containing D-Dimer is mixed with the D-Dimer Latex Reagent and Reaction Buffer, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of D-Dimer in the sample and is determined by measuring the decrease of the transmitted light caused by the aggregates (turbidimetric immunoassay).

Source page: https://510kreport.com/device/K972696
Methodology: https://510kreport.com/methodology