# K071781: PF4 IGG

- Pathway: 510(k) (Traditional)
- Applicant: Genetic Testing Institute
- Decided: Dec 19, 2007 after 170 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: 2 generations back to K983379 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053559: PF4 Enhanced Solid Phase Elisa, Genetic Testing Institute (2006) Summary page 1.

## Most influential descendants
- K201311: PF4 IgG assay (2020), 0 descendants of its own

## Indications for use
PF4 IgGTM is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum. The presence of heparin associated antibodies are commonly found in patients with Heparin Induced Thrombocytopenia (HIT).

Source page: https://510kreport.com/device/K071781
Methodology: https://510kreport.com/methodology