Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MMI — Predicate Candidate Screening
95 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
414 days90th percentile
95clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point of Care, Inc. | 2026-06-11 | 262 | 0 |
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | 2025-10-29 | 90 | 0 |
| K243483 | Access hsTnI | Beckman Coulter, Inc. | 2025-08-01 | 266 | 0 |
| K242870 | Access hsTnI | Beckman Coulter, Inc. | 2025-06-16 | 266 | 0 |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025-01-03 | 268 | 0 |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics, Inc. | 2024-07-25 | 90 | 0 |
| K231974 | PATHFAST®hs-cTnI-II | Phc Corporation | 2024-03-20 | 261 | 0 |
| K222881 | Access hsTnI | Beckman Coulter, Inc. | 2023-12-18 | 452 | 1 |
| K230648 | Access hsTnI | Beckman Coulter, Inc. | 2023-12-04 | 270 | 1 |
| K230994 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2023-05-04 | 27 | 0 |
| K202525 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2022-05-19 | 625 | 0 |
| K201441 | Elecsys Troponin T Gen 5 | Roche Diagnostics | 2021-09-21 | 477 | 0 |
| K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2019-09-13 | 88 | 0 |
| K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | 2019-05-17 | 63 | 0 |
| K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. | 2019-03-04 | 200 | 0 |
| K171566 | Atellica IM High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. | 2018-07-19 | 415 | 0 |
| K171274 | ADVIA Centaur High-Sensitivity Troponin I (TNIH) | Siemens Healthcare Diagnostics, Inc. | 2018-07-12 | 437 | 0 |
| K172787 | Access hsTnl | Beckman Coulter, Inc. | 2018-06-14 | 272 | 0 |
| K172783 | Access hs Tnl | Beckman Coulter, Inc. | 2018-06-12 | 270 | 1 |
| K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen | Roche Diagnostics | 2017-01-18 | 93 | 0 |
| K121790 | ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DX | Beckman Coulter, Inc. | 2013-09-25 | 464 | 5 |
| K121214 | ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FO | Beckman Coulter, Inc. | 2013-06-14 | 417 | 5 |
| K100130 | PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST S | Mitsubishi Chemical Medience CO | 2011-05-16 | 482 | 0 |
| K102441 | NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN | Nano-Ditech Corporation | 2010-10-20 | 83 | 0 |
| K102131 | NANO-CHECK AMI CTNI CARDIAC MARKER TEST | Nano-Ditech Corporation | 2010-10-20 | 83 | 0 |
| K082699 | ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS | Roche Diagnostics | 2009-08-19 | 338 | 2 |
| K081643 | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUEN | Siemens Healthcare Diagnostics | 2008-07-03 | 21 | 3 |
| K063243 | VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 | bioMerieux, Inc. | 2007-12-14 | 414 | 0 |
| K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN | Fisher Diagnostics | 2007-09-13 | 190 | 0 |
| K063756 | DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2007-03-19 | 90 | 1 |
| K062838 | VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRAT | Ortho-Clinical Diagnostics | 2006-12-19 | 89 | 2 |
| K060875 | ABBOTT AXSYM TROPONIN-I ADV | Abbott Laboratories | 2006-06-14 | 76 | 1 |
| K053577 | DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR | Dade Behring, Inc. | 2006-04-14 | 113 | 0 |
| K050975 | NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPO | Nano-Ditech Co. | 2006-03-02 | 318 | 0 |
| K053020 | TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM | Bayer Healthcare, LLC | 2005-12-30 | 65 | 3 |
| K052503 | TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYST | Bayer Healthcare, LLC | 2005-12-14 | 92 | 0 |
| K051925 | CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN | Access Bio Incorporate | 2005-11-29 | 134 | 0 |
| K050644 | VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST | Vancouver Biotech , Ltd. | 2005-08-17 | 156 | 0 |
| K051752 | ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) | Roche Diagnostics | 2005-07-11 | 12 | 1 |
| K041619 | BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 | Biocheck, Inc. | 2004-12-17 | 185 | 0 |
| K042227 | INSTANT-VIEW TROPONIN I TEST | Alfa Scientific Designs, Inc. | 2004-11-19 | 94 | 0 |
| K041811 | ABBOTT AXSYM TROPONIN-I ADV | Abbott Laboratories | 2004-09-10 | 66 | 2 |
| K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY | Fisher Diagnostics | 2004-08-12 | 98 | 3 |
| K033745 | RAMP TROPONIN I ASSAY | Response Biomedical Corp. | 2004-05-17 | 168 | 0 |
| K040733 | ELECSYS TROPONIN T STAT TEST | Roche Diagnostics Corp. | 2004-05-17 | 56 | 1 |
| K033487 | STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI | Dade Behring, Inc. | 2003-12-24 | 50 | 1 |
| K031031 | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND | Ortho-Clinical Diagnostics, Inc. | 2003-09-29 | 181 | 2 |
| K031739 | I-STAT CARDIAC TROPONIN (CTNI) TEST | I-Stat Corporation | 2003-09-02 | 90 | 4 |
| K030950 | VIDAS TROPONIN I (TNI), MODEL 30 445 | bioMerieux, Inc. | 2003-06-16 | 82 | 0 |
| K023505 | VBL SERUM TROPONIN I TEST, MODEL 1001 | Vancouver Biotech , Ltd. | 2003-03-31 | 164 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda