# K160885: HemosIL D-Dimer HS

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Oct 27, 2016 after 210 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: 6 generations back to K862156 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151534: HemosIL D-Dimer HS, Instrumentation Laboratory CO (2015) Summary page 4.

## 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). For in vitro diagnostic use.

Source page: https://510kreport.com/device/K160885
Methodology: https://510kreport.com/methodology