# K153137: HemosIL HIT-Ab (PF4-H), HemosIL HIT-Ab (PF4-H) Controls

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jul 8, 2016 after 252 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: 1 generation back to K003767 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003767: Asserachrom Hpia Test Kit, Diagnostica Stago, Inc. (2001) Summary page 4.

## Indications for use
HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 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. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP® Family of instruments.

Source page: https://510kreport.com/device/K153137
Methodology: https://510kreport.com/methodology