GJS · Test, Time, Prothrombin
Hematology · 21 CFR 864.7750 · Class 2
Overview
| Product Code | GJS |
|---|---|
| Device Name | Test, Time, Prothrombin |
| Regulation | 21 CFR 864.7750 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 127)
Showing 20 most recent of 127 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | Oct 24, 2025 | SESE |
| K251564 | microINR System | Iline Microsystems, S.L. | Jul 21, 2025 | SESE |
| K243543 | microINR System | Iline Microsystems, S.L. | Feb 27, 2025 | SESE |
| K230802 | Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. | Mar 15, 2024 | SESE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Abbott Laboratories | Jul 14, 2023 | SESE |
| K231711 | microINR System | Iline Microsystems, S.L. | Jul 11, 2023 | SESE |
| K211485 | STA- NeoPTimal | Diagnostica Stago S.A.S | Dec 23, 2022 | SESE |
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | Coagusense, Inc. | Oct 5, 2022 | SESE |
| K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory CO | Aug 16, 2022 | SESE |
| K201185 | microINR System | Iline Microsystems, S.L. | Dec 18, 2020 | SESE |
| K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | Feb 21, 2019 | SESE |
| K180780 | microINR System | Iline Microsystems, S.L. | Jan 25, 2019 | SESE |
| K180693 | CoaguChek XS Pro System | Roche Diagnostics | Apr 19, 2018 | SESE |
| K180684 | CoaguChek XS Plus System | Roche Diagnostics | Apr 19, 2018 | SESE |
| K170960 | CoaguChek Vantus System | Roche Diagnostics | Dec 25, 2017 | SESE |
| K151964 | Xprecia Stride Coagulation System, Xprecia System PT Controls | Siemens Healthcare Diagnostics | Sep 30, 2016 | SESE |
| K132722 | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) | Instrumentation Laboratory CO | Jan 22, 2014 | SESE |
| K122584 | HEMOSIL READIPLAS TIN | Instrumentation Laboratory CO | Mar 24, 2013 | SESE |
| K110212 | INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP | Alere San Diego, Inc (Formally Biosite Incorporate | May 1, 2012 | SESU |
| K092987 | INRATIO/INRATIO2 TEST STRIPS | Biosite Incorporated | Jun 11, 2010 | SESE |
Top Applicants
- Instrumentation Laboratory CO — 11 clearances
- International Technidyne Corp. — 8 clearances
- Roche Diagnostics — 7 clearances
- Roche Diagnostics Corp. — 7 clearances
- Helena Laboratories — 6 clearances
