# K053559: PF4 Enhanced Solid Phase Elisa

- Pathway: 510(k) (Special)
- Applicant: Genetic Testing Institute
- Decided: Jan 20, 2006 after 30 days
- Product code: LCO (Platelet Factor 4 Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 864.7695
- Recalls of this device: 2 (0 Class I)
- 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.
6 later devices descend from it; 3 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983379: Gti-PF4 Elisa, Genetic Testing Institute (1999) Summary page 1.

## Most influential descendants
- K071255: Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A (2007), 2 descendants of its own
- K170854: HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls (2017), 1 descendant of its own
- K071781: PF4 IGG (2007), 1 descendant of its own
- K243374: HemosIL CL HIT-IgG (PF4-H) (2025), 0 descendants of its own
- K201570: PF4 Enhanced assay (2020), 0 descendants of its own

## Recalls of this device
- Dec 15, 2014 · Class II · Z-1001-2015: Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demo
- Feb 4, 2013 · Class II · Z-1022-2013: Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reacti

## Indications for use
GTI PF4 ENHANCED® is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). The product is intended to be used as an in vitro diagnostics kit by hematology, coagulation or other pathology laboratories to assist in screening patient samples for the presence of heparin-associated antibodies commonly found in patients with heparin induced thrombocytopenia or thrombosis.

Source page: https://510kreport.com/device/K053559
Methodology: https://510kreport.com/methodology