Panels › Clinical Chemistry › Product code MMI · Class 2
Immunoassay Method, Troponin Subunit
Regulation 862.1215
1510(k)s in 12 months (95 all time)
0recalls in 12 months (56 all time)
54recalls that name a 510(k)
Top companies in MMI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2024 | Beckman Coulter, Inc. Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit.
For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma. Open, Classified |
MMI | K121214 K172783 +2 |
| Aug 8, 2023 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Troponin I ES Calibrators Open, Classified |
MMI | K062838 K992366 |
| Aug 8, 2023 | ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Troponin I ES Reagent Pack Open, Classified |
MMI | K062838 K992366 |
| Jul 7, 2023 | QUIDEL CARDIOVASCULAR INC Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045. Open, Classified |
MMI | K030286 |
| Jul 26, 2022 | Abbott Laboratories ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 Open, Classified |
MMI | K041192 |
| Jul 6, 2022 | Siemens Healthcare Diagnostics, Inc. Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction.
Siemens Mater Terminated |
MMI | None listed |
| Jul 6, 2022 | Siemens Healthcare Diagnostics, Inc. Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction.
Siemens Mate Terminated |
MMI | None listed |
| Aug 9, 2021 | Beckman Coulter Inc. Access hsTnI High Sensitivity Troponin I, REF B52699
Access Immunoassay System REAGENT PACK Open, Classified |
MMI | K172783 K172787 |
| Apr 7, 2021 | Roche Diagnostics Operations, Inc. Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. Open, Classified |
MMI | K082699 |
| Apr 7, 2021 | Roche Diagnostics Operations, Inc. Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. Open, Classified |
MMI | K082699 |
| Aug 19, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the
quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 1 Terminated |
MMI | K190675 |
| Jul 24, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma
Catalog Number K6427, SMN# 1 Terminated |
MMI | K182225 |
| Oct 16, 2019 | Abbott Point Of Care Inc. i-STAT cTnI cartridge Terminated |
MMI | K031739 K051433 |
| May 29, 2019 | Siemens Healthcare Diagnostics Inc Stratus CS Acute Care cTNI TestPak, SMN 10445071
Product Usage:
In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used a Terminated |
MMI | K051650 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridge Terminated |
MMI | K063756 |
| Mar 21, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205 Terminated |
MMI | K081643 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK cTnI 2nd Gen; Part Number: 025205
Assay, Cardiac Marker Terminated |
MMI | K012820 |
| May 5, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Troponin 1 (TNI) Flex reagent cartridge Terminated |
MMI | K081643 |
| May 2, 2016 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac trop Terminated |
MMI | K053020 |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma
Catalog Number: CCTNI
SMN: 10445071 Terminated |
MMI | K051650 |
| Jul 23, 2015 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests
Product Usage:
For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, Terminated |
MMI | K053020 |
| Dec 12, 2014 | Siemens Healthcare Diagnostics, Inc. Turbo Troponin I
For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI). Terminated |
MMI | K991795 |
| Jul 2, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790 Terminated |
MMI | K053020 |
| Jan 24, 2013 | Abbott Point of Care Canada Limited Abbott Point of Care i-Stat cTnI cartridge.
The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plas Terminated |
MMI | K031739 |
| Aug 22, 2012 | Abbott Point Of Care Inc. i-STAT cTnI cartridges
Product Usage:
The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac Terminated |
MMI | K031739 |
| Aug 9, 2012 | Abbott Point Of Care Inc. i-Stat cTnl cartridges
Abbott Point of Care Inc.
The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma sampl Terminated |
MMI | K031739 |
| May 10, 2012 | Abbott Laboratories ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratori Terminated |
MMI | K041192 |
| Apr 26, 2012 | Alere San Diego Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in Terminated |
MMI | K080269 |
| Apr 26, 2012 | Alere San Diego Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart fai Terminated |
MMI | K080269 |
| Apr 11, 2012 | Roche Diagnostics Operations, Inc. Elecsys Troponin I STAT Immunoassay
For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial i Terminated |
MMI | K082699 |
| Apr 11, 2012 | Roche Diagnostics Operations, Inc. Elecsys Troponin I Immunoassay
For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarc Terminated |
MMI | K082699 |
| Nov 10, 2011 | Abbott Point Of Care Inc. i-Stat cTnI cartridges
Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Terminated |
MMI | K031739 |
| Apr 4, 2011 | Beckman Coulter Inc. Access Immunoassay Systems enhanced AccuTnl Reagent Kit, Part Number: A78803
The Access Accu Tri assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of c Terminated |
MMI | K010429 K021814 |
| Mar 18, 2011 | Siemens Healthcare Diagnostics, Inc. Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay
The Stratus(R) CS Acute CareTM Troponin I method (CTNI) is an in vitro diagnostic test for the measurement of cardiac Troponin I in hepar Terminated |
MMI | K051650 |
| Nov 24, 2010 | Siemens Healthcare Diagnostics, Inc. The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE. Terminated |
MMI | K081643 |
| Sep 11, 2010 | Siemens Healthcare Diagnostics, Inc. Stratus CS Acute Care Troponin I TestPak ( Troponin I assay) Terminated |
MMI | K051650 |
| Jul 12, 2010 | Beckman Coulter Inc. Access Immunoassay Systems enhanced AccuTnl Reagent Kit; Part Number: A78803
The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ca Terminated |
MMI | K010429 K021814 |
| Apr 12, 2010 | Beckman Coulter Inc. Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems; Reagent Part Numbers: A78803 & 33340; Calibrator Part Number: 33345
The intended Terminated |
MMI | K010429 K021814 |
| Feb 25, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521.
Intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the Terminated |
MMI | K010313 |
| Aug 12, 2009 | Siemens Healthcare Diagnostics, Inc. Dimension Cardiac Troponin I Flex reagent cartridge (CTNI).
The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test inten Terminated |
MMI | K010313 |
| May 8, 2009 | Biosite Inc Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box.
Fluorescence immunoassay kit to be used with the Triage Meter for the quantitative determi Terminated |
MMI | K030286 |
| Apr 15, 2009 | Abbott Laboratories AxSYM Troponin-I ADV Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM Troponin-I ADV is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin- Terminated |
MMI | K060875 |
| Jun 5, 2008 | Siemens Medical Solutions Diagnostics ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, T Terminated |
MMI | K053020 |
| Apr 28, 2008 | Siemens Healthcare Diagnostics, Inc. Siemens Stratus CS Acute Care Troponin I CalPak.
In vitro product intended to be used for calibration of the cardiac troponin I method on the Stratus CS analyzer. Terminated |
MMI | K051650 |
| Mar 19, 2008 | Beckman Coulter Inc UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822 Terminated |
MMI | K023764 |
| Jul 11, 2007 | Abbott Laboratories AxSYM Troponin-I ADV Reagent Pack; list 02J44; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MMI | K041811 |
| Jun 14, 2007 | Abbott Laboratories MPG ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Ab Terminated |
MMI | K041192 |
| May 26, 2007 | Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK Terminated |
MMI | K031031 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNI-D) in vitro diagnostic. Terminated |
MMI | K981098 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) in vitro diagnostic. Terminated |
MMI | K033487 |
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