# K090264: Hemosil D-Dimer HS 500, Controls

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Feb 5, 2010 after 367 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). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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.
- K070927: Hemosil D-Dimer HS, Instrumentation Laboratory CO (2007) Summary page 1.
- K972696: IL Test D-Dimer, Instrumentation Laboratory CO (1997) Summary page 1.

## Most influential descendants
- K172903: HemosIL D-Dimer HS 500 (2017), 0 descendants of its own

## Indications for use
HemosIL D-Dimer HS 500 is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP (RFamily 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). HemosIL D-Dimer HS 500 Controls are intended for the quality control of the D-Dimter HS 500 assay performed on the ACL TOP® Family Systems.

Source page: https://510kreport.com/device/K090264
Methodology: https://510kreport.com/methodology