# K170854: HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 8, 2017 after 170 days
- Product code: LCO (Platelet Factor 4 Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 864.7695
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K983379 (1999). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071255: Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A, Hyphen Biomed (2007) Summary page 4.

## Most influential descendants
- K243374: HemosIL CL HIT-IgG (PF4-H) (2025), 0 descendants of its own

## Recalls of this device
- Sep 3, 2026 · Class I · Z-0002-2027: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
- Sep 3, 2026 · Class I · Z-0001-2027: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

## Indications for use
HemosIL AcuStar 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% or 3.8% citrated plasma and serum on the ACL AcuStar instrument 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. HemoslL AcuStar HIT Controls are for the quality control of the HemosIL AcuStar HIT-IgG(PF4-H) assay as performed on the ACL AcuStar.

Source page: https://510kreport.com/device/K170854
Methodology: https://510kreport.com/methodology