JBR · Test, Heparin Neutralization
Hematology · 21 CFR 864.7525 · Class 2
Overview
| Product Code | JBR |
|---|---|
| Device Name | Test, Heparin Neutralization |
| Regulation | 21 CFR 864.7525 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K925452 | DADE HEPZYME | Baxter Diagnostics, Inc. | Jan 11, 1993 | SESE |
| K874373 | PT PRO-CLOT | Probe-Tek, Inc. | Jan 5, 1988 | SESE |
| K770722 | THROMBO SCREEN QUANTITATIVE HEPARIN ASSA | Bay Area Hema. Onco. Clinic. & Res. L | Jul 11, 1977 | SESE |
Top Applicants
- Baxter Diagnostics, Inc. — 1 clearance
- Bay Area Hema. Onco. Clinic. & Res. L — 1 clearance
- Probe-Tek, Inc. — 1 clearance
