# K201570: PF4 Enhanced assay

- Pathway: 510(k) (Special)
- Applicant: Immucor Gti Diagnostics, Inc.
- Decided: Sep 11, 2020 after 92 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.
No later device cites it as a predicate yet.
0 of 3 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 4.

## Indications for use
PF4 Enhanced assay is designed as a solid phase enzyme linked immunosorbent assay (ELISA). The product is intended to be used as an in vitro diagnostic kit by hematology, coagulation, or other pathology laboratories to assist in screening patient samples, 3.2% sodium citrate (plasma) or without anticoagulant (serum), for the presence of heparin associated commonly found in patients with heparin induced thrombocytopenia (HIT) or thrombosis.

Source page: https://510kreport.com/device/K201570
Methodology: https://510kreport.com/methodology