# K040293: Healthtest Heparin/Platelet Factor 4 Antibody Assay

- Pathway: 510(k) (Traditional)
- Applicant: Akers Laboratories, Inc.
- Decided: May 28, 2004 after 112 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 K983379 (1999). 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)
- K983379: Gti-PF4 Elisa, Genetic Testing Institute (1999) Summary page 1.

## Indications for use
The HEALTHTEST® Heparin/Platelet Factor 4 Antibody Assay is a qualitative in vitro diagnostic device designed for the detection of antibodies to the Platelet Factor 4 complexed to polyanionic compounds such as polystyrene. These antibodies are found in some patients undergoing heparin therapy. The risk of heparin induced thrombocytopenia (HIT) is greatly increased in patients with recent exposure to heparin. The presence of heparin/PF-4 antibody is associated with patients at risk for HIT, and is rapidly becoming a standard of care in hematology and cardiology. The need for a rapid test to detect these antibodies from serum or plasma in less than 5 minutes is highly desired. This rapid manual assay should be easily performed when STAT results are required.

Source page: https://510kreport.com/device/K040293
Methodology: https://510kreport.com/methodology