KFF · Assay, Heparin
Hematology · 21 CFR 864.7525 · Class 2
Overview
| Product Code | KFF |
|---|---|
| Device Name | Assay, Heparin |
| 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 (20 of 46)
Showing 20 most recent of 46 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | Oct 4, 2022 | SESE |
| K162540 | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls | Siemens Healthcare Diagnostics Prodcts GmbH | Aug 22, 2017 | SESE |
| K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH | Diagnostica Stago, Inc. | Oct 26, 2011 | SESE |
| K090209 | HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS | Instrumentation Laboratory CO | Jun 2, 2009 | SESE |
| K050367 | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | Hyphen Biomed | May 24, 2006 | SESE |
| K013305 | ENOXAPARIN TEST CARD | Cardiovascular Diagnostics, Inc. | Aug 23, 2002 | SESE |
| K013637 | ACTICHROME HEPARIN (ANTI-FIIA) | American Diagnostica, Inc. | Apr 16, 2002 | SESE |
| K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | American Diagnostica, Inc. | Mar 8, 2002 | SESE |
| K010455 | ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN | Diagnostica-Stago | Jun 7, 2001 | SESE |
| K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | International Technidyne Corp. | Jun 6, 2001 | SESE |
| K983178 | COAMATIC HEPARIN | Instrumentation Laboratory CO | Nov 3, 1998 | SESE |
| K980242 | IL TEST HEPARIN | Instrumentation Laboratory CO | Mar 19, 1998 | SESE |
| K972209 | SPECTROLYSE HEPARIN (ANTI-IIA) | Medical Diagnostic Technologies, Inc. | Aug 12, 1997 | SESE |
| K965076 | MDA HEPARIN ANTI-X ASSAY | Organon Teknika Corp. | Mar 18, 1997 | SESE |
| K952667 | CHROM Z-HEPARIN, CAT. NO 5242 | Helena Laboratories | Feb 14, 1996 | SESE |
| K952514 | COACUTE HEPARIN | Chromogenix AB | Nov 20, 1995 | SESE |
| K943520 | HEPARIN CONTROL KIT | American Bioproducts Co. | Sep 26, 1995 | SESK |
| K943519 | HBPM/LMWH CONTROL KIT | American Bioproducts Co. | Sep 26, 1995 | SESK |
| K943514 | THE HEPANORM HBPM/LMWH KIT | American Bioproducts Co. | Sep 26, 1995 | SESK |
| K943516 | ROTACHROM HBPM/LMWH TEST KIT | American Bioproducts Co. | Aug 31, 1995 | SESE |
Top Applicants
- American Bioproducts Co. — 8 clearances
- Instrumentation Laboratory CO — 6 clearances
- American Diagnostica, Inc. — 2 clearances
- Cardiovascular Diagnostics, Inc. — 2 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 2 clearances
