# K221359: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 29, 2023 after 506 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: 6 generations back to K862156 (1986). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083518: Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls, Instrumentation Laboratory CO (2009) Summary page 4.
- K092181: Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm Controls, Instrumentation Laboratory CO (2010) Summary page 4.
- K091556: Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls, Instrumentation Laboratory CO (2010) Summary page 4.

## Indications for use
The ACL TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory. The system provides results for both direct measurements and calculated parameters. HemosIL CL Anti-Cardiolipin IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. For use with adult population. For prescription use only. HemosIL CL Anti-B2 Glycoprotein-1 IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 Glycoprotein-1 (anti-B2GPI) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. For use with adult population. For prescription use only.

Source page: https://510kreport.com/device/K221359
Methodology: https://510kreport.com/methodology