Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7140](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7140) → JBP — Activated Whole Blood Clotting Time # JBP · Activated Whole Blood Clotting Time _Hematology · 21 CFR 864.7140 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP ## Overview - **Product Code:** JBP - **Device Name:** Activated Whole Blood Clotting Time - **Regulation:** [21 CFR 864.7140](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7140) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **3rd-party reviewable:** yes ## Identification An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 24) Showing 20 most recent of 24 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K223635](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K223635.md) | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | Sienco, Inc. | Jan 4, 2023 | SESE | | [K062604](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K062604.md) | RAPIDTEG TEG-ACT TEST | Haemoscope Corp. | Jan 31, 2007 | SESE | | [K032952](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K032952.md) | AIACT KIT | Sienco, Inc. | Dec 12, 2003 | SESE | | [K023582](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K023582.md) | I-STAT KAOLIN ACT TEST | I-Stat Corporation | Sep 8, 2003 | SESE | | [K020914](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K020914.md) | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 | Helena Laboratories | May 23, 2002 | SESE | | [K013078](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K013078.md) | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 | Helena Laboratories | Jan 10, 2002 | SESE | | [K002528](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K002528.md) | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION | Sienco, Inc. | Aug 31, 2000 | SESE | | [K994194](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K994194.md) | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT | Cardiovascular Diagnostics, Inc. | Mar 28, 2000 | SESE | | [K992571](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K992571.md) | I-STAT SYSTEM | I-Stat Corp. | Feb 10, 2000 | SESE | | [K992851](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K992851.md) | ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM | Roche Diagnostics Corp. | Jan 14, 2000 | SESE | | [K984141](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K984141.md) | GBACT + KIT | Sienco, Inc. | May 28, 1999 | SESE | | [K983649](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K983649.md) | MAX-ACT | Array Medical, Inc. | Dec 11, 1998 | SESE | | [K971935](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K971935.md) | B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) | B & D Corp. | Oct 1, 1997 | SESE | | [K964609](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K964609.md) | ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE | Array Medical, Inc. | Mar 6, 1997 | SESE | | [K960749](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K960749.md) | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | International Technidyne Corp. | Aug 12, 1996 | SESE | | [K941007](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K941007.md) | CATALOG NO. J-ACT+ & QC-ACT+ | International Technidyne Corp. | Jun 30, 1994 | SESE | | [K923594](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K923594.md) | CLOTTRAC COAGULATION CONTROL | Medtronic Hemotec, Inc. | Sep 21, 1992 | SESE | | [K913861](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K913861.md) | HEMOCHRON(R) KACT | International Technidyne Corp. | Oct 18, 1991 | SESE | | [K902081](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K902081.md) | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL | Hemotec, Inc. | Jul 3, 1990 | SESE | | [K854686](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K854686.md) | TE-25 COAGURO METER | Future Impex Corp. | Jun 4, 1986 | SESE | ## Top Applicants - International Technidyne Corp. — 4 clearances - Sienco, Inc. — 4 clearances - Array Medical, Inc. — 2 clearances - Helena Laboratories — 2 clearances - Hemotec, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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