JPA · System, Multipurpose For In Vitro Coagulation Studies

Hematology · 21 CFR 864.5425 · Class 2

Overview

Product CodeJPA
Device NameSystem, Multipurpose For In Vitro Coagulation Studies
Regulation21 CFR 864.5425
Device ClassClass 2
Review PanelHematology
3rd-Party ReviewableYes

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.

RecordDevice NameApplicantDecision DateDecision
K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.Jun 2, 2025SESE
K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsApr 30, 2025SESE
K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationJan 15, 2025SESE
K232018Citrated: K, KH, RTH, FFHHaemonetics CorporationMar 29, 2024SESE
K233790ACL TOP 970 CLInstrumentation LaboratoryDec 29, 2023SESE
K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory COSep 29, 2023SESE
K212183STA R Max 3, STA Compact Max 3Diagnostica Stago S.A.SJun 7, 2023SESE
K201440ROTEM sigma Thromboelastometry SystemTem Innovations GmbHJul 8, 2022SESE
K202101GEM 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 2Accriva Diagnostics, Inc.Dec 29, 2021SESE
K193041Hemochron Signature EliteAccriva Diagnostics, Inc.Nov 22, 2019SESE
K183390QNext and DG-PTDiagnostic Grifols, S.A.Aug 21, 2019SESE
K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeHaemonetics CorporationMay 9, 2019SESE
K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd.May 9, 2018SESE
K172286Automated Blood Coagulation Analyzer CS-2500Siemens Healthcare Diagnostic Products GmbHDec 18, 2017SESE
K172333Sysmex CS-5100Siemens Healthcare Diagnostics Products GmbHOct 31, 2017SESE
K160502TEG 6s Hemostasis SystemHaemonetics CorporationApr 19, 2017SESE
K170314ACL AcuStarInstrumentation Laboratory COMar 3, 2017SESE
K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbHDec 26, 2016SESE
K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbHDec 12, 2016SESE
K161317Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbHSep 2, 2016SESE

Top Applicants

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