PF4 Enhanced assay
FDA 510(k) K201570 · Immucor Gti Diagnostics, Inc.
510(k) numberK201570
Submission
- Device name
- PF4 Enhanced assay
- Applicant
- Immucor Gti Diagnostics, Inc.
Waukesha, WI, US - Received
- June 11, 2020
- Decision date
- September 11, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCO – Platelet Factor 4 Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7695
- Specialty
- Hematology
Other 510(k)s with product code LCO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243374 | HemosIL CL HIT-IgG(PF4-H)LCO · Traditional | Instrumentation Laboratory (IL) Co. | 01/28/2025SE |
| K201311 | PF4 IgG assayLCO · Special | Immucor Gti Diagnostics, Inc. | 06/18/2020SE |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsLCO · Traditional | Instrumentation Laboratory CO | 09/08/2017SE |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsLCO · Traditional | Instrumentation Laboratory CO | 07/08/2016SE |
| K071781 | PF4 IggLCO · Traditional | Genetic Testing Institute | 12/19/2007SE |
| K071255 | Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040ALCO · Traditional | Hyphen Biomed | 09/07/2007SE |
| K053559 | PF4 Enhanced Solid Phase ElisaLCO · Special | Genetic Testing Institute | 01/20/2006SE |
| K040293 | Healthtest Heparin/Platelet Factor 4 Antibody AssayLCO · Traditional | Akers Laboratories, Inc. | 05/28/2004SE |
| K003767 | Asserachrom Hpia Test KitLCO · Traditional | Diagnostica Stago, Inc. | 02/12/2001SE |
| K983379 | GTI-PF4 ElisaLCO · Traditional | Genetic Testing Institute | 03/09/1999SE |
More from Genetic Testing Institute
| 510(k) | Device | Decision |
|---|---|---|
| K201311 | PF4 IgG assayLCO · Special | 06/18/2020SE |
Questions and answers
When was PF4 Enhanced assay cleared by the FDA?
PF4 Enhanced assay (K201570) received a 510(k) decision of Substantially Equivalent on September 11, 2020, 92 days after the submission was received.
What is the product code of K201570?
The FDA product code is LCO – Platelet Factor 4 Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 864.7695.