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K Number
K983379
Device Name
GTI-PF4 ELISA
Manufacturer
GENETIC TESTING INSTITUTE
Date Cleared
1999-03-09

(165 days)

Product Code
LCO
Regulation Number
864.7695
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

GTI-PF4 ELISA is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).

AI/ML Overview

This is an FDA 510(k) clearance letter and an Indications for Use statement, not a scientific study report. Therefore, it does not contain the detailed information needed to describe acceptance criteria and a study proving a device meets those criteria in the format requested.

The document states:

  • Device Name: GTI-PF4 ELISA
  • Intended Use: "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."
  • Regulatory Class: II

To answer your request, a comprehensive study report or a 510(k) summary would be required. The provided text only informs that the device has received 510(k) clearance based on substantial equivalence to a predicate device, but it does not detail the specific performance studies, acceptance criteria, or ground truth methodologies used by the manufacturer to demonstrate that equivalence.

§ 864.7695 Platelet factor 4 radioimmunoassay.

(a)
Identification. A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.(b)
Classification. Class II (performance standards).