FDA Product Code JPA: System, Multipurpose For In Vitro Coagulation Studies
Under FDA product code JPA, multipurpose in vitro coagulation study systems are cleared for comprehensive coagulation testing in clinical laboratories.
These analyzer platforms perform multiple coagulation assays — including PT, aPTT, fibrinogen, and specialized factor assays — on a single instrument, providing a complete coagulation profile for the diagnosis and monitoring of bleeding and thrombotic disorders.
JPA devices are Class II medical devices, regulated under 21 CFR 864.5425 and reviewed by the FDA Hematology panel.
Leading manufacturers include Dade Behring, Inc., Instrumentation Laboratory CO and Helena Laboratories.
181
Total
181
Cleared
118d
Avg days
1976
Since
Stable submission activity - 4 submissions in the last 2 years
Review times improving: avg
70d
recently vs 119d historically
FDA 510(k) Cleared System, Multipurpose For In Vitro Coagulation Studies Devices (Product Code JPA)
181 devices
Cleared
Apr 27, 2026
STA Satellite Max®
Diagnostica Stago, Inc.
Hematology
158d
Cleared
Jun 02, 2025
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
Sysmex America, Inc.
Hematology
63d
Cleared
Apr 30, 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
Haemonetics
Hematology
28d
Cleared
Jan 15, 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
Haemonetics Corporation
Hematology
30d
Cleared
Mar 29, 2024
Citrated: K, KH, RTH, FFH
Haemonetics Corporation
Hematology
266d
Cleared
Dec 29, 2023
ACL TOP 970 CL
Instrumentation Laboratory
Hematology
31d
Cleared
Sep 29, 2023
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
Instrumentation Laboratory CO
Hematology
506d
Cleared
Jun 07, 2023
STA R Max 3, STA Compact Max 3
Diagnostica Stago S.A.S
Hematology
694d
Cleared
Jul 08, 2022
ROTEM sigma Thromboelastometry System
Tem Innovations GmbH
Hematology
767d
Cleared
Dec 29, 2021
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.
Hematology
518d
Cleared
Nov 22, 2019
Hemochron Signature Elite
Accriva Diagnostics, Inc.
Hematology
22d
Cleared
Aug 21, 2019
QNext and DG-PT
Diagnostic Grifols, S.A.
Hematology
258d
Cleared
May 09, 2019
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
Haemonetics Corporation
Hematology
175d
Cleared
May 09, 2018
CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
Sekisui Medical Co., Ltd.
Hematology
219d
Cleared
Mar 03, 2017
ACL AcuStar
Instrumentation Laboratory CO
Hematology
30d
Cleared
Mar 13, 2009
ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
Instrumentation Laboratory CO
Hematology
107d
Cleared
May 10, 2006
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
Helena Laboratories
Hematology
27d
Cleared
Feb 21, 2006
ACL ELITE
Instrumentation Laboratory CO
Hematology
29d
Cleared
Dec 23, 2005
COAG-A-MATE MTX III
bioMerieux, Inc.
Hematology
245d
Cleared
Jul 11, 2005
HEMORAM/AGGRAM ANALYZER
Helena Laboratories
Hematology
182d
Cleared
Apr 01, 2005
MDA B.30
bioMerieux, Inc.
Hematology
31d
Cleared
Mar 19, 2004
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
Instrumentation Laboratory CO
Hematology
35d
Cleared
Jan 16, 2003
MODIFICATION TO STANDARD HUMAN PLASMA
Dade Behring, Inc.
Hematology
118d
Cleared
Nov 09, 2001
BCS SYSTEM
Dade Behring, Inc.
Hematology
52d
About Product Code JPA - Regulatory Context
510(k) Submission Activity
181 total 510(k) submissions under product code JPA since 1976, with 181 receiving FDA clearance (average review time: 118 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA 510(k) Review Time - JPA Product Code
Recent submissions under JPA have taken an average of 70 days to reach a decision - down from 119 days historically, suggesting improved FDA processing for this classification.
JPA devices are reviewed by the Hematology panel. Browse all Hematology devices →