PF4 Enhanced Solid Phase ELISA
510(k) K053559
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053559 | Date20 Jan 2006 | StatusActive |
Recalls
-
- Terminated 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 demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.
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- Terminated 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 reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LCO
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7695
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The PF4 Enhanced Solid Phase ELISA is a qualitative in vitro diagnostic device classified as a Platelet Factor 4 Radioimmunoassay (OpenFDA classification: LCO). It employs a solid-phase enzyme-linked immunosorbent assay (ELISA) to detect antibodies reactive with platelet factor 4 (PF4) when complexed to polyanionic compounds, such as polyvinyl sulfonate (PVS). This assay is specifically designed for use in hematology to aid in the identification of heparin-induced thrombocytopenia (HIT) risk in patients undergoing heparin therapy. The device operates by binding PF4 antibodies present in patient serum to immobilized PF4-PVS complexes on a microplate, enabling visual or instrumental detection of the immune response.
The PF4 Enhanced Solid Phase ELISA is supplied as a kit for use in pathology laboratories and requires manual handling by trained personnel. It is intended for single-use per manufacturer specifications and is not sterile as packaged. The device is classified under FDA 510(k) clearance (K053559) with a Special Review designation, falling under Device Class II (OpenFDA). No MRI safety information is provided, and storage conditions are not explicitly detailed in the regulatory data. The product is regulated under FDA regulation number 864.7695 and is intended for in vitro diagnostic use only.
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Questions
AI-generated answers, 1 Oct 2026
What is the PF4 Enhanced Solid Phase ELISA used for?
This device is designed to detect antibodies reactive with platelet factor 4 (PF4) when bound to polyanionic compounds like polyvinyl sulfonate (PVS). It aids in identifying patients at risk for heparin-induced thrombocytopenia (HIT) during heparin therapy, supporting clinical decision-making in hematology.
How is the PF4 Enhanced Solid Phase ELISA supplied and prepared for use?
The kit is supplied as a complete assay system for manual use in pathology laboratories by trained personnel. It includes all necessary reagents and components for a single test run, but it requires manual handling and preparation per the manufacturer’s instructions.
Is the PF4 Enhanced Solid Phase ELISA sterile as packaged?
No, the device is not sterile as packaged. It is intended for single-use only and must be handled in a controlled laboratory environment to prevent contamination before use.
What regulatory pathway does the PF4 Enhanced Solid Phase ELISA follow?
The device is classified under FDA 510(k) clearance (K053559) with a Special Review designation, falling under Device Class II. It is regulated under FDA regulation number 864.7695 and is intended exclusively for in vitro diagnostic use.
Are there specific storage instructions for the PF4 Enhanced Solid Phase ELISA?
The regulatory data does not explicitly detail storage conditions for this device. Laboratories should follow the manufacturer’s instructions provided in the kit documentation to ensure optimal performance and stability of reagents.