# K073042: Hemosil D-Dimer

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory
- Decided: Jul 31, 2008 after 276 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: 5 generations back to K862156 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070927: Hemosil D-Dimer HS, Instrumentation Laboratory CO (2007) Summary page 1.
- K050278: Hemosil D-Dimer, Instrumentation Laboratory CO (2005) Summary page 1.

## Indications for use
HemosIL D-Dimer is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on IL Coagulation Systems for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE).

Source page: https://510kreport.com/device/K073042
Methodology: https://510kreport.com/methodology