# K243374: HemosIL CL HIT-IgG (PF4-H)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory (IL) Co.
- Decided: Jan 28, 2025 after 90 days
- Product code: LCO (Platelet Factor 4 Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 864.7695
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K983379 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170854: HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls, Instrumentation Laboratory CO (2017) Summary page 5.

## Indications for use
HemosIL CL HIT-IgG(PF4-H) is a qualitative, fully automated, chemiluminescent immunoassay (CIA) for the detection of IgG antibodies that react with Platelet Factor 4 (PF4) when complexed to heparin. The assay is for use in human 3.2% citrated plasma on the ACL TOP 970 CL in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.00 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT.

Source page: https://510kreport.com/device/K243374
Methodology: https://510kreport.com/methodology