# K083518: Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Mar 13, 2009 after 107 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- 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
Longest line of descent: 5 generations back to K862156 (1986). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891385: Vitek Immunodiagnostic Assay System (Vidas), Vitek Systems, Inc. (1989) Summary page 1.
- K040882: Vidas D-Dimer Exclusion Assay, Model 30 442, bioMerieux, Inc. (2004) Summary page 1.
- K073377: Acl Top (with System Software V3.0.0), Instrumentation Laboratory CO (2008) 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
- K221359: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM (2023), 0 descendants of its own
- K170314: ACL AcuStar (2017), 0 descendants of its own

## Indications for use
ACL AcuStar: Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology. The system provides results for both direct measurements and calculated parameters. HemosIL AcuStar D-Dimer: Fully automated chemiluminescent immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL AcuStar as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary embolism (PE)]. HemosIL AcuStar D-Dimer Controls: For the quality control of D-Dimer assay performed on the ACL AcuStar.

Source page: https://510kreport.com/device/K083518
Methodology: https://510kreport.com/methodology