Product Code: MMI FDA class 2 21 CFR 862.1215

Immunoassay Method, Troponin Subunit

Clinical Chemistry

The Troponin Subunit Immunoassay is an in vitro diagnostic device used to measure the concentration of cardiac troponin I or troponin T subunits in patient blood, which are highly specific biomarkers for myocardial injury used in the diagnosis of acute myocardial infarction and risk stratification in patients with chest pain. Classified as a Class 2 device under 21 CFR 862.1215 within the Clinical Chemistry specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MMI
Device Class: FDA class 2
Regulation Number: 862.1215
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 95 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253051	i-STAT hs-TnI cartridge with the i-STAT Alinity System	Jun 11, 2026	Substantially Equivalent	Abbott Point of Care, Inc.
K252393	VITROS Immunodiagnostic Products hs Troponin I Reagent Pack	Oct 29, 2025	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K243483	Access hsTnI	Aug 01, 2025	Substantially Equivalent	Beckman Coulter, Inc.
K242870	Access hsTnI	Jun 16, 2025	Substantially Equivalent	Beckman Coulter, Inc.
K240984	i-STAT hs-TnI cartridge with the i-STAT 1 System	Jan 03, 2025	Substantially Equivalent	Abbott Point of Care, Inc.
K241165	Atellica® IM High-Sensitivity Troponin I (TnIH)	Jul 25, 2024	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K231974	PATHFAST®hs-cTnI-II	Mar 20, 2024	Substantially Equivalent	Phc Corporation
K222881	Access hsTnI	Dec 18, 2023	Substantially Equivalent	Beckman Coulter, Inc.
K230648	Access hsTnI	Dec 04, 2023	Substantially Equivalent	Beckman Coulter, Inc.
K230994	Alinity i STAT High Sensitivity Troponin-I	May 04, 2023	Substantially Equivalent	Abbott Laboratories Diagnostics Division
K202525	Alinity i STAT High Sensitivity Troponin-I	May 19, 2022	Substantially Equivalent	Abbott Laboratories Diagnostics Division
K201441	Elecsys Troponin T Gen 5	Sep 21, 2021	Substantially Equivalent	Roche Diagnostics
K191595	ARCHITECT STAT High Sensitivity Troponin-I	Sep 13, 2019	Substantially Equivalent	Abbott Laboratories Diagnostics Division
K190675	Dimension EXL High-Sensitivity Troponin I (TNIH) Assay	May 17, 2019	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K182225	Dimension Vista High-Sensitivity Troponin I (TNIH) Assay	Mar 04, 2019	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K171566	Atellica IM High-Sensitivity Troponin I (TNIH)	Jul 19, 2018	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K171274	ADVIA Centaur High-Sensitivity Troponin I (TNIH)	Jul 12, 2018	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K172787	Access hsTnl	Jun 14, 2018	Substantially Equivalent	Beckman Coulter, Inc.
K172783	Access hs Tnl	Jun 12, 2018	Substantially Equivalent	Beckman Coulter, Inc.
K162895	Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5	Jan 18, 2017	Substantially Equivalent	Roche Diagnostics
K121790	ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM	Sep 25, 2013	Substantially Equivalent	Beckman Coulter, Inc.
K121214	ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM	Jun 14, 2013	Substantially Equivalent	Beckman Coulter, Inc.
K100130	PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2	May 16, 2011	Substantially Equivalent	Mitsubishi Chemical Medience CO
K102441	NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN	Oct 20, 2010	Substantially Equivalent	Nano-Ditech Corporation
K102131	NANO-CHECK AMI CTNI CARDIAC MARKER TEST	Oct 20, 2010	Substantially Equivalent	Nano-Ditech Corporation
K082699	ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS	Aug 19, 2009	Substantially Equivalent	Roche Diagnostics
K081643	DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692	Jul 03, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics
K063243	VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448	Dec 14, 2007	Substantially Equivalent	bioMerieux, Inc.
K070640	ARCHITECT STAT TROPONIN-1; MYOGLOBIN	Sep 13, 2007	Substantially Equivalent	Fisher Diagnostics
K063756	DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE	Mar 19, 2007	Substantially Equivalent	Dade Behring, Inc.
K062838	VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303	Dec 19, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics
K060875	ABBOTT AXSYM TROPONIN-I ADV	Jun 14, 2006	Substantially Equivalent	Abbott Laboratories
K053577	DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT	Apr 14, 2006	Substantially Equivalent	Dade Behring, Inc.
K050975	NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN	Mar 02, 2006	Substantially Equivalent	Nano-Ditech Co.
K053020	TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM	Dec 30, 2005	Substantially Equivalent	Bayer Healthcare, LLC
K052503	TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM	Dec 14, 2005	Substantially Equivalent	Bayer Healthcare, LLC
K051925	CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN	Nov 29, 2005	Substantially Equivalent	Access Bio Incorporate
K050644	VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT	Aug 17, 2005	Substantially Equivalent	Vancouver Biotech , Ltd.
K051752	ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)	Jul 11, 2005	Substantially Equivalent	Roche Diagnostics
K041619	BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116	Dec 17, 2004	Substantially Equivalent	Biocheck, Inc.
K042227	INSTANT-VIEW TROPONIN I TEST	Nov 19, 2004	Substantially Equivalent	Alfa Scientific Designs, Inc.
K041811	ABBOTT AXSYM TROPONIN-I ADV	Sep 10, 2004	Substantially Equivalent	Abbott Laboratories
K041192	ARCHITECT STAT TROPONIN-I IMMUNOASSAY	Aug 12, 2004	Substantially Equivalent	Fisher Diagnostics
K040733	ELECSYS TROPONIN T STAT TEST	May 17, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K033745	RAMP TROPONIN I ASSAY	May 17, 2004	Substantially Equivalent	Response Biomedical Corp.
K033487	STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI	Dec 24, 2003	Substantially Equivalent	Dade Behring, Inc.
K031031	VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS	Sep 29, 2003	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K031739	I-STAT CARDIAC TROPONIN (CTNI) TEST	Sep 02, 2003	Substantially Equivalent	I-Stat Corporation
K030950	VIDAS TROPONIN I (TNI), MODEL 30 445	Jun 16, 2003	Substantially Equivalent	bioMerieux, Inc.
K023505	VBL SERUM TROPONIN I TEST, MODEL 1001	Mar 31, 2003	Substantially Equivalent	Vancouver Biotech , Ltd.
K030057	SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST	Mar 19, 2003	Substantially Equivalent	Spectral Diagnostics, Inc.
K024193	MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS	Feb 21, 2003	Substantially Equivalent	Ortho-Clinical Diagnostics
K022946	LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST	Oct 08, 2002	Substantially Equivalent	Princeton BioMeditech Corp.
K021814	ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345	Sep 27, 2002	Substantially Equivalent	Beckman Coulter, Inc.
K020950	SPECTRAL'S 2 IN 1 (TNI-MYO)	May 24, 2002	Substantially Equivalent	Spectral Diagnostics, Inc.
K020662	MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS	Apr 12, 2002	Substantially Equivalent	Ortho-Clinical Diagnostics
K014105	SPECTRAL'S TROPONIN I	Feb 01, 2002	Substantially Equivalent	Spectral Diagnostics, Inc.
K013062	BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT	Jan 08, 2002	Substantially Equivalent	Biocheck, Inc.
K014024	MODIFICATION TO ALPHA DX SYSTEM	Dec 18, 2001	Substantially Equivalent	First Medical, Inc.
K012820	AIA-PACK CTNI 2ND-GEN ASSAY	Dec 14, 2001	Substantially Equivalent	Tosoh Medics, Inc.
K010429	ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345	Jun 05, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K010313	DIMENSION CTNI FLEX REAGENT CARTRIDGE	Apr 20, 2001	Substantially Equivalent	Dade Behring, Inc.
K010201	BAYER ADVIA IMS SYSTEM	Mar 29, 2001	Substantially Equivalent	Bayer Corp.
K010562	ALPHA DX SYSTEM	Mar 13, 2001	Substantially Equivalent	First Medical, Inc.
K000784	THE CARDIAC READER SYSTEM	May 18, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K993353	TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)	Dec 06, 1999	Substantially Equivalent	Bayer Corp.
K993309	BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY	Dec 06, 1999	Substantially Equivalent	Bayer Corp.
K992366	VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK	Oct 08, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K992127	CARDIOQUANT TROPONIN I TEST	Oct 04, 1999	Substantially Equivalent	Spectral Diagnostics, Inc.
K991177	OPUS TROPONIN I (CTN) TEST MODULES	Jul 01, 1999	Substantially Equivalent	Dade Behring, Inc.
K991795	IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5	Jun 09, 1999	Substantially Equivalent	Diagnostic Products Corp.
K984359	AIA-PACK TROPONIN I ASSAY	Dec 23, 1998	Substantially Equivalent	Tosoh Medics, Inc.
K984093	STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK	Dec 14, 1998	Substantially Equivalent	Dade Behring, Inc.
K984105	ELECSYS TROPONIN T STAT TEST	Dec 08, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K983972	IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15	Dec 07, 1998	Substantially Equivalent	Diagnostic Products Corp.
K981882	CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST	Jul 06, 1998	Substantially Equivalent	Princeton BioMeditech Corp.
K981098	STRATUS CS CARDIAC TROPONIN I TESTPAK	Apr 27, 1998	Substantially Equivalent	Dade Behring, Inc.
K980528	CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)	Mar 03, 1998	Substantially Equivalent	Chiron Diagnostics Corp.
K974839	ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT	Feb 04, 1998	Substantially Equivalent	First Medical, Inc.
K974818	ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM	Jan 16, 1998	Substantially Equivalent	Radiometer America, Inc.
K973616	TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM	Dec 05, 1997	Substantially Equivalent	Bayer Corp.
K974103	ABBOTT AXSYM TROPONIN-I	Nov 25, 1997	Substantially Equivalent	Abbott Laboratories
K974075	ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	Nov 10, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K973650	TROPONIN (TROP) METHOD	Oct 20, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K972094	TARGET CARDIAC TROPONIN I TEST	Jul 23, 1997	Substantially Equivalent	Texas Immunology, Inc.
K964862	TROPONIN-I TEST SYSTEM	Feb 10, 1997	Substantially Equivalent	Dade Intl., Inc.
K964372	CARDIAC T TROPONIN T RAPID ASSAY	Feb 10, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K963934	ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329	Dec 16, 1996	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K963513	CARDIAC STATUS TROPONIN I	Nov 07, 1996	Substantially Equivalent	Princeton BioMeditech Corp.
K961500	ELECSYS TROPONIN T	Jun 11, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K955868	BOEHRINGER MANNHEIM CARDIAC T TROPNIN T	Feb 14, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K955284	OPUS TROPONIN I	Jan 25, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K952478	BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY	Nov 09, 1995	Substantially Equivalent	Boehringer Mannheim Corp.
K951890	STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS	Jul 13, 1995	Substantially Equivalent	Dade Intl., Inc.
K924392	CARDIAC T ELISA TROPONIN-T	Apr 26, 1994	Substantially Equivalent	Boehringer Mannheim Corp.