JBQ · Antithrombin Iii Quantitation
Hematology · 21 CFR 864.7060 · Class 2
Overview
| Product Code | JBQ |
|---|---|
| Device Name | Antithrombin Iii Quantitation |
| Regulation | 21 CFR 864.7060 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH | Mar 28, 2025 | SESE |
| K081769 | INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 | Siemens Healthcare Diagnostics | May 28, 2009 | SESE |
| K070301 | HEMOSIL ANTITHROMBIN | Instrumentation Laboratory CO | Feb 23, 2007 | SESE |
| K062431 | HEMOSIL LIQUID ANTITHROMBIN | Instrumentation Laboratory CO | Sep 1, 2006 | SESE |
| K043007 | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 | Hyphen Biomed | Nov 7, 2005 | SESE |
| K033775 | HEMOSIL LIQUID ANTITHROMBIN XL | Instrumentation Laboratory CO | Jan 2, 2004 | SESE |
| K023991 | CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 | Precision Biologic | Apr 28, 2003 | SESE |
| K022550 | COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS | Instrumentation Laboratory CO | Aug 27, 2002 | SESE |
| K022195 | COAMATIC AT-400 | Instrumentation Laboratory CO | Aug 7, 2002 | SESE |
| K994238 | IL TEST LIQUID ANTITHROMBIN | Instrumentation Laboratory CO | Jun 23, 2000 | SESE |
| K000361 | K-ASSAY AT-III | Kamiya Biomedical Co. | Apr 26, 2000 | SESE |
| K980499 | IL TEST ANTITHROMBIN | Instrumentation Laboratory CO | Apr 2, 1998 | SESE |
| K974110 | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | Beckman Instruments, Inc. | Dec 24, 1997 | SESE |
| K972144 | SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III | Sigma Diagnostics, Inc. | Jul 25, 1997 | SESE |
| K960871 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | Medical Diagnostic Technologies, Inc. | Aug 14, 1996 | SESE |
| K952515 | COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY | Chromogenix AB | Jan 23, 1996 | SESE |
| K951943 | CHROM Z CHROMOGENIC ASSAYS | Helena Laboratories | Nov 13, 1995 | SESE |
| K944279 | AT-III CALIBRATOR | American Bioproducts Co. | Apr 7, 1995 | SESE |
| K934156 | BIOMERIEUX HEMOLAB AT III | Biomerieux Vitek, Inc. | Dec 22, 1994 | SESE |
| K935308 | ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY | Sigma Diagnostics, Inc. | May 17, 1994 | SESE |
Top Applicants
- Instrumentation Laboratory CO — 9 clearances
- Sigma Diagnostics, Inc. — 2 clearances
- Pharmaseal Div., Baxter Healthcare Corp. — 2 clearances
- Ortho Diagnostics, Inc. — 2 clearances
- Helena Laboratories — 2 clearances
