# K133582: Hemosil D-Dimer HS 500 Control

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory
- Decided: Aug 15, 2014 after 267 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
HemosIL D-Dimer HS 500 Controls are assayed, human-sourced controls intended for the quality control of the HemosIL D-Dimer HS 500 assay as performed on the ACL TOP Family System, in a clinical laboratory setting. The controls are intended for in vitro diagnostic use. Level 1 D-D HS 500 Control is intended for the assessment of precision and accuracy of the assay around the clinical cut-off for VTE (500 ng/mL FEU). Level 2 D-D HS 500 Control is intended for the assessment of precision and accuracy of the assay at abnormal D-Dimer levels (above the cut-off).

Source page: https://510kreport.com/device/K133582
Methodology: https://510kreport.com/methodology