# K070927: Hemosil D-Dimer HS

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 17, 2007 after 167 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: 4 generations back to K862156 (1986). 4 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040882: Vidas D-Dimer Exclusion Assay, Model 30 442, bioMerieux, Inc. (2004) Summary page 1.

## Most influential descendants
- K083518: Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls (2009), 2 descendants of its own
- K151534: HemosIL D-Dimer HS (2015), 1 descendant of its own
- K090264: Hemosil D-Dimer HS 500, Controls (2010), 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
HemosIL D-Dimer HS is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP 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/K070927
Methodology: https://510kreport.com/methodology