LCO · Platelet Factor 4 Radioimmunoassay
Hematology · 21 CFR 864.7695 · Class 2
Overview
| Product Code | LCO |
|---|---|
| Device Name | Platelet Factor 4 Radioimmunoassay |
| Regulation | 21 CFR 864.7695 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243374 | HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. | Jan 28, 2025 | SESE |
| K201570 | PF4 Enhanced assay | Immucor Gti Diagnostics, Inc. | Sep 11, 2020 | SESE |
| K201311 | PF4 IgG assay | Immucor Gti Diagnostics, Inc. | Jun 18, 2020 | SESE |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | Sep 8, 2017 | SESE |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | Instrumentation Laboratory CO | Jul 8, 2016 | SESE |
| K071781 | PF4 IGG | Genetic Testing Institute | Dec 19, 2007 | SESE |
| K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | Hyphen Biomed | Sep 7, 2007 | SESE |
| K053559 | PF4 ENHANCED SOLID PHASE ELISA | Genetic Testing Institute | Jan 20, 2006 | SESE |
| K040293 | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY | Akers Laboratories, Inc. | May 28, 2004 | SESE |
| K003767 | ASSERACHROM HPIA TEST KIT | Diagnostica Stago, Inc. | Feb 12, 2001 | SESE |
| K983379 | GTI-PF4 ELISA | Genetic Testing Institute | Mar 9, 1999 | SESE |
| K890633 | ENZYGNOST PLATELET FACTOR 4 (PF4) KIT | Behring Diagnostics, Inc. | Apr 21, 1989 | SESE |
| K862774 | ASSERACHROM PF4 KIT | American Bioproducts Co. | Sep 4, 1986 | SESE |
Top Applicants
- Genetic Testing Institute — 3 clearances
- Instrumentation Laboratory CO — 2 clearances
- Immucor Gti Diagnostics, Inc. — 2 clearances
- Instrumentation Laboratory (IL) Co. — 1 clearance
- Hyphen Biomed — 1 clearance
