Assay, Heparin
FDA product code KFF · Class II (moderate risk) · 21 CFR 864.7525 · Hematology
46510(k) clearances
0PMA approvals
11recalls
Manufacturers
- American Bioproducts Co. 8
- Instrumentation Laboratory CO 6
- Cardiovascular Diagnostics, Inc. 2
- Diagnostica Stago, Inc. 2
- American Diagnostica, Inc. 2
- E.I. Dupont DE Nemours & Co., Inc. 2
- International Technidyne Corp. 2
- Organon Teknika Corp. 2
- Hemotec, Inc. 1
- Behring Diagnostics, Inc. 1
- Siemens Healthcare Diagnostics Prodcts GmbH 1
- Intensive Technology, Inc. 1
- Kabi Diagnostica 1
- Ortho Diagnostic Systems, Inc. 1
- Dade, Baxter Travenol Diagnostics, Inc. 1
- Haemachem, Inc. 1
- Warner-Lambert Co. 1
- Western Laboratories Corp. 1
- Kabivitrum, Inc. 1
- Wellcome Diagnostics 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213464 | HemosIL Liquid Anti-XaKFF · Special | Instrumentation Laboratory CO | 10/04/2022SE |
| K162540 | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF…KFF · Traditional | Siemens Healthcare Diagnostics Prodcts GmbH | 08/22/2017SE |
| K111822 | Sta(R) - Liquid Anti-Xa, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWHKFF · Traditional | Diagnostica Stago, Inc. | 10/26/2011SE |
| K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and Uf Heparin ControlsKFF · Traditional | Instrumentation Laboratory CO | 06/02/2009SE |
| K050367 | Biophen Heparin 3, Biophen Heparin 6KFF · Traditional | Hyphen Biomed | 05/24/2006SE |
| K013305 | Enoxaparin Test CardKFF · Traditional | Cardiovascular Diagnostics, Inc. | 08/23/2002SE |
| K013637 | Actichrome Heparin (Anti-Fiia)KFF · Traditional | American Diagnostica, Inc. | 04/16/2002SE |
| K013318 | Actichrome Heparin (Anti-Fxa), Model 832KFF · Traditional | American Diagnostica, Inc. | 03/08/2002SE |
| K010455 | Rotachrom Heparin and Sta -Rotachrom HeparinKFF · Traditional | Diagnostica-Stago | 06/07/2001SE |
| K010193 | Hemochron Kaolin-Activated Heparin and Protamine Dosing AssaysKFF · Traditional | International Technidyne Corp. | 06/06/2001SE |
| K983178 | Coamatic HeparinKFF · Traditional | Instrumentation Laboratory CO | 11/03/1998SE |
| K980242 | Il Test HeparinKFF · Traditional | Instrumentation Laboratory CO | 03/19/1998SE |
| K972209 | Spectrolyse Heparin (Anti-Iia)KFF · Traditional | Medical Diagnostic Technologies, Inc. | 08/12/1997SE |
| K965076 | Mda Heparin Anti-X AssayKFF · Traditional | Organon Teknika Corp. | 03/18/1997SE |
| K952667 | Chrom Z-Heparin, Cat. No 5242KFF · Traditional | Helena Laboratories | 02/14/1996SE |
| K952514 | Coacute HeparinKFF · Traditional | Chromogenix AB | 11/20/1995SE |
| K943520 | Heparin Control KitKFF · Traditional | American Bioproducts Co. | 09/26/1995SESK |
| K943519 | Hbpm/Lmwh Control KitKFF · Traditional | American Bioproducts Co. | 09/26/1995SESK |
| K943514 | The Hepanorm Hbpm/Lmwh KitKFF · Traditional | American Bioproducts Co. | 09/26/1995SESK |
| K943516 | Rotachrom Hbpm/Lmwh Test KitKFF · Traditional | American Bioproducts Co. | 08/31/1995SE |
| K943515 | Rotachrom Heparin Test KitKFF · Traditional | American Bioproducts Co. | 08/31/1995SE |
| K925433 | The Stachrom Heparin Assay KitKFF · Traditional | American Bioproducts Co. | 05/23/1995SE |
| K943517 | Staclot Heparin Test KitKFF · Traditional | American Bioproducts Co. | 05/11/1995SE |
| K943283 | Heparin Management Test Card; HMT CardKFF · Traditional | Cardiovascular Diagnostics, Inc. | 05/10/1995SE |
| K934274 | Hemolab Heparichrom AssayKFF · Traditional | Biomerieux Vitek, Inc. | 05/06/1994SE |
| K935212 | Il Test Heparin (Xa), PN 84699-15KFF · Traditional | Instrumentation Laboratory CO | 02/07/1994SE |
| K923499 | Spectrolyse Heparin KitKFF · Traditional | Biopool AB | 01/27/1994SE |
| K925200 | Berichrom HeparinKFF · Traditional | Behring Diagnostics, Inc. | 06/28/1993SE |
| K910181 | Hitt by Hemochron(R)KFF · Traditional | International Technidyne Corp. | 05/10/1991SE |
| K910741 | Heparin Controls, High and LowKFF · Traditional | Sigma Diagnostics, Inc. | 04/29/1991SE |
| K904003 | Hemochron(R) Heparin Response TestKFF · Traditional | Intensive Technology, Inc. | 11/29/1990SE |
| K903841 | Organon Teknida Chromostrae (TM) Heparin Anti-XaKFF · Traditional | Organon Teknika Corp. | 10/22/1990SE |
| K901874 | Coatest LMW Heparin/Heparin Chromogenic AssayKFF · Traditional | Kabi Diagnostica | 07/20/1990SE |
| K900396 | Orthokrome* HeparinKFF · Traditional | Ortho Diagnostic Systems, Inc. | 03/15/1990SE |
| K884590 | Hepcon/System B-10 Heparin Assay/Screen/CartridgesKFF · Traditional | Hemotec, Inc. | 01/10/1989SE |
| K864211 | Il Test 97575-15, Heparin AssayKFF · Traditional | Instrumentation Laboratory CO | 01/05/1987SE |
| K854762 | Hepanorm Calibration Plasma SetKFF · Traditional | American Bioproducts Co. | 03/03/1986SE |
| K853239 | Heptest-A Quantitative Heparin in Plasma AssayKFF · Traditional | Haemachem, Inc. | 11/05/1985SE |
| K850486 | General Diag. Chromostrate Heparin AssayKFF · Traditional | Warner-Lambert Co. | 05/08/1985SE |
| K843202 | Heparin Calibrator AcaKFF · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 11/30/1984SE |
| K843201 | Heparin Aca Analytical Test PackKFF · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 11/30/1984SE |
| K834024 | HeparinometerKFF · Traditional | Western Laboratories Corp. | 06/11/1984SE |
| K833891 | Coatest HeparinKFF · Traditional | Kabivitrum, Inc. | 01/30/1984SE |
| K832373 | Diacrom * HeparinKFF · Traditional | Wellcome Diagnostics | 09/29/1983SE |
| K812424 | Ci-Trol Heparin Controls, Low/HighKFF · Traditional | American Dade | 10/02/1981SE |
| K781479 | Heparin AssayKFF · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 02/15/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2475-2025 Class II | STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are…Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | Diagnostica Stago, Inc. | 07/21/2025Open, Classified |
| Z-2474-2025 Class II | STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are…Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | Diagnostica Stago, Inc. | 07/21/2025Open, Classified |
| Z-2323-2025 Class II | HemosIL LMW Heparin Controls; Part Number: 0020300200;Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC… | Instrumentation Laboratory | 02/03/2025Open, Classified |
| Z-1020-2025 Class II | HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnosticControl indicating lower than expected quality control (QC) results and in some instances QC recovery below… | Instrumentation Laboratory | 12/18/2024Open, Classified |
| Z-1307-2023 Class II | ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the…Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL… | Instrumentation Laboratory | 02/03/2023Open, Classified |
| Z-1306-2023 Class II | ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis…Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL… | Instrumentation Laboratory | 02/03/2023Open, Classified |
| Z-1305-2023 Class II | ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis…Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL… | Instrumentation Laboratory | 02/03/2023Open, Classified |
| Z-1304-2023 Class II | ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory…Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL… | Instrumentation Laboratory | 02/03/2023Open, Classified |
| Z-0149-2022 Class II | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination…Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument… | Instrumentation Laboratory | 08/25/2021Open, Classified |
| Z-2650-2014 Class III | Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended…Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate)… | Diagnostica Stago, Inc. | 07/18/2014Terminated |
| Z-2110-2010 | RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and…An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may… | International Technidyne Corp. | 06/24/2010Terminated |