Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5680](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5680) → JOX — Analyzer, Heparin, Automated # JOX · Analyzer, Heparin, Automated _Hematology · 21 CFR 864.5680 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX ## Overview - **Product Code:** JOX - **Device Name:** Analyzer, Heparin, Automated - **Regulation:** [21 CFR 864.5680](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5680) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **3rd-party reviewable:** yes ## Identification An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation. ## Classification Rationale Class II (special controls). ## Special Controls *Classification.* Class II (special controls). ## Recent Cleared Devices (15 of 15) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K111339](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K111339.md) | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) | Medtronic, Inc. | Jun 8, 2011 | SESE | | [K102953](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K102953.md) | HEPARIN DOSE RESPONSE CARTRIDGE | Medtronic, Inc. | Nov 4, 2010 | SESE | | [K101271](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K101271.md) | HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX | Medtronic, Inc. | Oct 13, 2010 | SESE | | [K051040](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K051040.md) | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Perfusion Systems | May 24, 2005 | SESE | | [K043080](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K043080.md) | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Vascular | Dec 3, 2004 | SESE | | [K042070](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K042070.md) | HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 | Medtronic Vascular | Oct 1, 2004 | SESE | | [K993519](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K993519.md) | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST | Cardiovascular Diagnostics, Inc. | Jan 14, 2000 | SESE | | [K922031](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K922031.md) | HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL | Medtronic Hemotec, Inc. | Jul 21, 1992 | SESE | | [K911240](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K911240.md) | HEPCON HMS WITH BODY SURFACE AREA CALCULATION | Hemotech, Inc. | Jul 17, 1991 | SESE | | [K894317](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K894317.md) | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | Hemotec, Inc. | Sep 5, 1989 | SESE | | [K854377](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K854377.md) | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | Hemotec, Inc. | Dec 4, 1985 | SESE | | [K841021](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K841021.md) | HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM | Hemotec, Inc. | May 25, 1984 | SESE | | [K830665](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K830665.md) | HEPCOL SYSTEM B-10 & B-10-P | Hemotec, Inc. | Jun 8, 1983 | SESE | | [K813011](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K813011.md) | HEPAQUANT | Streck Laboratories, Inc. | Jan 26, 1982 | SESE | | [K800161](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K800161.md) | HEPCON/SYSTEM RC-10 | Hemotec, Inc. | Mar 19, 1980 | SESE | ## Top Applicants - Hemotec, Inc. — 5 clearances - Medtronic, Inc. — 3 clearances - Medtronic Vascular — 2 clearances - Cardiovascular Diagnostics, Inc. — 1 clearance - Hemotech, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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