FDA Product Code GJS: Test, Time, Prothrombin
Monitoring the coagulation cascade is critical in patients on anticoagulant therapy. FDA product code GJS covers prothrombin time tests.
The PT test measures the time it takes for plasma to clot via the extrinsic coagulation pathway, reflecting the activity of factors I, II, V, VII, and X. It is expressed as INR for warfarin monitoring and is used in the assessment of liver function and coagulopathies.
GJS devices are Class II medical devices, regulated under 21 CFR 864.7750 and reviewed by the FDA Hematology panel.
Leading manufacturers include Instrumentation Laboratory CO, Roche Diagnostics Corp. and Helena Laboratories.
127
Total
127
Cleared
137d
Avg days
1978
Since
Declining activity -
3 submissions in the last 2 years
vs 6 in the prior period
Review times improving: avg
64d
recently vs 138d historically
FDA 510(k) Cleared Test, Time, Prothrombin Devices (Product Code GJS)
127 devices
Cleared
Oct 24, 2025
CoaguChek XS Plus System
Roche Diagnostics
Hematology
28d
Cleared
Jul 21, 2025
microINR System
Iline Microsystems, S.L.
Hematology
60d
Cleared
Feb 27, 2025
microINR System
Iline Microsystems, S.L.
Hematology
104d
Cleared
Mar 15, 2024
Xprecia Prime Coagulation System
Universal Biosensors Pty, Ltd.
Hematology
358d
Cleared
Jul 14, 2023
i-STAT PTplus Cartridge with the i-STAT 1 System
Abbott Laboratories
Hematology
528d
Cleared
Jul 11, 2023
microINR System
Iline Microsystems, S.L.
Hematology
29d
Cleared
Dec 23, 2022
STA- NeoPTimal
Diagnostica Stago S.A.S
Hematology
589d
Cleared
Oct 05, 2022
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
Coagusense, Inc.
Hematology
399d
Cleared
Aug 16, 2022
HemosIL ReadiPlasTin
Instrumentation Laboratory CO
Hematology
299d
Cleared
Dec 18, 2020
microINR System
Iline Microsystems, S.L.
Hematology
231d
Cleared
Feb 21, 2019
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
Coagusense, Inc.
Hematology
92d
Cleared
Jan 25, 2019
microINR System
Iline Microsystems, S.L.
Hematology
305d
Cleared
Apr 19, 2018
CoaguChek XS Plus System
Roche Diagnostics
Hematology
35d
Cleared
Apr 19, 2018
CoaguChek XS Pro System
Roche Diagnostics
Hematology
34d
Cleared
Dec 25, 2017
CoaguChek Vantus System
Roche Diagnostics
Hematology
269d
Cleared
Sep 30, 2016
Xprecia Stride Coagulation System, Xprecia System PT Controls
Siemens Healthcare Diagnostics
Hematology
442d
Cleared
Jan 22, 2014
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
Instrumentation Laboratory CO
Hematology
145d
Cleared
Mar 24, 2013
HEMOSIL READIPLAS TIN
Instrumentation Laboratory CO
Hematology
212d
Cleared
Mar 05, 2010
COAGUCHEK XS PLUS PST SYSTEM
Roche Diagnostics Corp.
Hematology
162d
Cleared
Jan 31, 2008
HANDHELD BASE UNIT
Roche Diagnostics Corp.
Hematology
108d
Cleared
Aug 15, 2007
HEMOSIL RECOMBIPLASTIN 2G
Instrumentation Laboratory CO
Hematology
224d
Cleared
Jan 29, 2007
COAGUCHEK XS SYSTEM
Roche Diagnostics Corp.
Hematology
123d
Cleared
May 02, 2006
HEMOSIL PT-FIBRINOGEN HS PLUS
Instrumentation Laboratory CO
Hematology
27d
Cleared
Dec 22, 2004
HEMOSIL RECOMBIPLASTIN
Instrumentation Laboratory CO
Hematology
35d
About Product Code GJS - Regulatory Context
510(k) Submission Activity
127 total 510(k) submissions under product code GJS since 1978, with 127 receiving FDA clearance (average review time: 137 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 6 in the prior period.
FDA 510(k) Review Time - GJS Product Code
Recent submissions under GJS have taken an average of 64 days to reach a decision - down from 138 days historically, suggesting improved FDA processing for this classification.
GJS devices are reviewed by the Hematology panel. Browse all Hematology devices →