# K201311: PF4 IgG assay

- Pathway: 510(k) (Special)
- Applicant: Immucor Gti Diagnostics, Inc.
- Decided: Jun 18, 2020 after 31 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: 3 generations back to K983379 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071781: PF4 IGG, Genetic Testing Institute (2007) Summary page 4.

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

Source page: https://510kreport.com/device/K201311
Methodology: https://510kreport.com/methodology