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 864.5425](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5425) → JPA — System, Multipurpose For In Vitro Coagulation Studies # JPA · System, Multipurpose For In Vitro Coagulation Studies _Hematology · 21 CFR 864.5425 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA ## Overview - **Product Code:** JPA - **Device Name:** System, Multipurpose For In Vitro Coagulation Studies - **Regulation:** [21 CFR 864.5425](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5425) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **3rd-party reviewable:** yes ## Identification A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays. ## Classification Rationale Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. ## Special Controls *Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. ## Recent Cleared Devices (20 of 180) Showing 20 most recent of 180 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250965](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K250965.md) | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | Sysmex America, Inc. | Jun 2, 2025 | SESE | | [K251024](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K251024.md) | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics | Apr 30, 2025 | SESE | | [K243858](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K243858.md) | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation | Jan 15, 2025 | SESE | | [K232018](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K232018.md) | Citrated: K, KH, RTH, FFH | Haemonetics Corporation | Mar 29, 2024 | SESE | | [K233790](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K233790.md) | ACL TOP 970 CL | Instrumentation Laboratory | Dec 29, 2023 | SESE | | [K221359](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K221359.md) | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | Instrumentation Laboratory CO | Sep 29, 2023 | SESE | | [K212183](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K212183.md) | STA R Max 3, STA Compact Max 3 | Diagnostica Stago S.A.S | Jun 7, 2023 | SESE | | [K201440](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K201440.md) | ROTEM sigma Thromboelastometry System | Tem Innovations GmbH | Jul 8, 2022 | SESE | | [K202101](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K202101.md) | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 | Accriva Diagnostics, Inc. | Dec 29, 2021 | SESE | | [K193041](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K193041.md) | Hemochron Signature Elite | Accriva Diagnostics, Inc. | Nov 22, 2019 | SESE | | [K183390](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K183390.md) | QNext and DG-PT | Diagnostic Grifols, S.A. | Aug 21, 2019 | SESE | | [K183160](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K183160.md) | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | Haemonetics Corporation | May 9, 2019 | SESE | | [K173202](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K173202.md) | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set | Sekisui Medical Co., Ltd. | May 9, 2018 | SESE | | [K172286](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K172286.md) | Automated Blood Coagulation Analyzer CS-2500 | Siemens Healthcare Diagnostic Products GmbH | Dec 18, 2017 | SESE | | [K172333](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K172333.md) | Sysmex CS-5100 | Siemens Healthcare Diagnostics Products GmbH | Oct 31, 2017 | SESE | | [K160502](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K160502.md) | TEG 6s Hemostasis System | Haemonetics Corporation | Apr 19, 2017 | SESE | | [K170314](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K170314.md) | ACL AcuStar | Instrumentation Laboratory CO | Mar 3, 2017 | SESE | | [K162688](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K162688.md) | Sysmex CS-2100i | Siemens Healthcare Diagnostics Products GmbH | Dec 26, 2016 | SESE | | [K162420](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K162420.md) | Sysmex Automated Blood Coagulation Analyzer CS-5100 | Siemens Healthcare Diagnostics Products GmbH | Dec 12, 2016 | SESE | | [K161317](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA/K161317.md) | Sysmex Automated Blood Coagulation Analyzer CS-5100 | Siemens Healthcare Diagnostics Products GmbH | Sep 2, 2016 | SESE | ## Top Applicants - Bio/Data Corp. — 13 clearances - Dade Behring, Inc. — 12 clearances - Instrumentation Laboratory CO — 11 clearances - International Technidyne Corp. — 9 clearances - Helena Laboratories — 8 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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