Product code MMI— Clinical Chemistry
Access hsTnI
- Classification name
- Immunoassay Method, Troponin Subunit
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Total cleared
- 95
- First cleared
- Most recent
Market context for product code MMI
FDA has cleared devices under product code MMI between 1994 and 2026, filed by 39 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2019
- 2018
- 2017
- 2013
- 2011
- 2010
- 2009
- 2008
- 2007
Top applicants under product code MMI
Adverse events under product code MMI
product code MMI- Injury
- 172
- Malfunction
- 3,762
- Total
- 3,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MMI
- K253051 — i-STAT hs-TnI cartridge with the i-STAT Alinity System
- K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
- K243483 — Access hsTnI
- K242870 — Access hsTnI
- K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System
- K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH)
- K231974 — PATHFAST®hs-cTnI-II
- K222881 — Access hsTnI
- K230648 — Access hsTnI
- K230994 — Alinity i STAT High Sensitivity Troponin-I
- K202525 — Alinity i STAT High Sensitivity Troponin-I
- K201441 — Elecsys Troponin T Gen 5
- K191595 — ARCHITECT STAT High Sensitivity Troponin-I
- K190675 — Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
- K182225 — Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
- K171566 — Atellica IM High-Sensitivity Troponin I (TNIH)
- K171274 — ADVIA Centaur High-Sensitivity Troponin I (TNIH)
- K172787 — Access hsTnl
- K172783 — Access hs Tnl
- 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
- K121790 — ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
- K121214 — ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
- K100130 — PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
- K102131 — NANO-CHECK AMI CTNI CARDIAC MARKER TEST
- K102441 — NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN
- K082699 — ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
- K081643 — DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
- K063243 — VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
- K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN
- K063756 — DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
- K062838 — VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
- K060875 — ABBOTT AXSYM TROPONIN-I ADV
- K053577 — DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT
- K050975 — NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN
- K053020 — TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
- K052503 — TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
- K051925 — CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
- K050644 — VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT
- K051752 — ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
- K041619 — BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
- K042227 — INSTANT-VIEW TROPONIN I TEST
- K041811 — ABBOTT AXSYM TROPONIN-I ADV
- K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAY
- K033745 — RAMP TROPONIN I ASSAY
- K040733 — ELECSYS TROPONIN T STAT TEST
- K033487 — STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
- K031031 — VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
- K031739 — I-STAT CARDIAC TROPONIN (CTNI) TEST
- K030950 — VIDAS TROPONIN I (TNI), MODEL 30 445
- K023505 — VBL SERUM TROPONIN I TEST, MODEL 1001
- K030057 — SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
- K024193 — MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
- K022946 — LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
- K021814 — ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
- K020950 — SPECTRAL'S 2 IN 1 (TNI-MYO)
- K020662 — MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
- K014105 — SPECTRAL'S TROPONIN I
- K013062 — BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
- K014024 — MODIFICATION TO ALPHA DX SYSTEM
- K012820 — AIA-PACK CTNI 2ND-GEN ASSAY
- K010429 — ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
- K010313 — DIMENSION CTNI FLEX REAGENT CARTRIDGE
- K010201 — BAYER ADVIA IMS SYSTEM
- K010562 — ALPHA DX SYSTEM
- K000784 — THE CARDIAC READER SYSTEM
- K993309 — BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
- K993353 — TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
- K992366 — VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
- K992127 — CARDIOQUANT TROPONIN I TEST
- K991177 — OPUS TROPONIN I (CTN) TEST MODULES
- K991795 — IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
- K984359 — AIA-PACK TROPONIN I ASSAY
- K984093 — STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
- K984105 — ELECSYS TROPONIN T STAT TEST
- K983972 — IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
- K981882 — CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
- K981098 — STRATUS CS CARDIAC TROPONIN I TESTPAK
- K980528 — CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
- 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
- K974818 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
- K973616 — TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K974103 — ABBOTT AXSYM TROPONIN-I
- K974075 — ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- K973650 — TROPONIN (TROP) METHOD
- K972094 — TARGET CARDIAC TROPONIN I TEST
- K964372 — CARDIAC T TROPONIN T RAPID ASSAY
- K964862 — TROPONIN-I TEST SYSTEM
- K963934 — ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329
- K963513 — CARDIAC STATUS TROPONIN I
- K961500 — ELECSYS TROPONIN T
- K955868 — BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
- K955284 — OPUS TROPONIN I
- K952478 — BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY
- K951890 — STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS
- K924392 — CARDIAC T ELISA TROPONIN-T
Data sourced from openFDA. This site is unofficial and independent of the FDA.