Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7525](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7525) → KFF — Assay, Heparin # KFF · Assay, Heparin _Hematology · 21 CFR 864.7525 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF ## Overview - **Product Code:** KFF - **Device Name:** Assay, Heparin - **Regulation:** [21 CFR 864.7525](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7525) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **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](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K213464.md) | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | Oct 4, 2022 | SESE | | [K162540](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K162540.md) | 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](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K111822.md) | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH | Diagnostica Stago, Inc. | Oct 26, 2011 | SESE | | [K090209](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K090209.md) | HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS | Instrumentation Laboratory CO | Jun 2, 2009 | SESE | | [K050367](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K050367.md) | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | Hyphen Biomed | May 24, 2006 | SESE | | [K013305](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K013305.md) | ENOXAPARIN TEST CARD | Cardiovascular Diagnostics, Inc. | Aug 23, 2002 | SESE | | [K013637](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K013637.md) | ACTICHROME HEPARIN (ANTI-FIIA) | American Diagnostica, Inc. | Apr 16, 2002 | SESE | | [K013318](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K013318.md) | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | American Diagnostica, Inc. | Mar 8, 2002 | SESE | | [K010455](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K010455.md) | ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN | Diagnostica-Stago | Jun 7, 2001 | SESE | | [K010193](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K010193.md) | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | International Technidyne Corp. | Jun 6, 2001 | SESE | | [K983178](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K983178.md) | COAMATIC HEPARIN | Instrumentation Laboratory CO | Nov 3, 1998 | SESE | | [K980242](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K980242.md) | IL TEST HEPARIN | Instrumentation Laboratory CO | Mar 19, 1998 | SESE | | [K972209](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K972209.md) | SPECTROLYSE HEPARIN (ANTI-IIA) | Medical Diagnostic Technologies, Inc. | Aug 12, 1997 | SESE | | [K965076](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K965076.md) | MDA HEPARIN ANTI-X ASSAY | Organon Teknika Corp. | Mar 18, 1997 | SESE | | [K952667](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K952667.md) | CHROM Z-HEPARIN, CAT. NO 5242 | Helena Laboratories | Feb 14, 1996 | SESE | | [K952514](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K952514.md) | COACUTE HEPARIN | Chromogenix AB | Nov 20, 1995 | SESE | | [K943520](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K943520.md) | HEPARIN CONTROL KIT | American Bioproducts Co. | Sep 26, 1995 | SESK | | [K943519](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K943519.md) | HBPM/LMWH CONTROL KIT | American Bioproducts Co. | Sep 26, 1995 | SESK | | [K943514](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K943514.md) | THE HEPANORM HBPM/LMWH KIT | American Bioproducts Co. | Sep 26, 1995 | SESK | | [K943516](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF/K943516.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KFF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com