# K983379: Gti-PF4 Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Genetic Testing Institute
- Decided: Mar 9, 1999 after 165 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
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053559: PF4 Enhanced Solid Phase Elisa (2006), 6 descendants of its own
- 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

## Indications for use
INDICATIONS FOR USE OF GTI-PF4 ELISA FOR THE DETECTION OF ANTIBODIES DIRECTED AGAINST PLATELET FACTOR 4 (PF4):POLYVINYL SULFONATE (PVS) COMPLEX GTI-PF4 ELISA 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 for the presence of heparin-associated antibodies commonly found in patients with heparin-induced thrombocytopenia or thrombosis.

Source page: https://510kreport.com/device/K983379
Methodology: https://510kreport.com/methodology