Home / 510(k) Clearances / K162895

510(k) 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 by Roche Diagnostics — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2017
Date Received
October 17, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay Method, Troponin Subunit
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Roche Diagnostics

  • K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (February 12, 2026)
  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K253839 — Elecsys Anti-SARS-CoV-2 (December 17, 2025)
  • K253188 — CoaguChek XS Plus System (October 24, 2025)
  • K252163 — Elecsys Phospho-Tau (181P) Plasma (October 8, 2025)
  • K242505 — Elecsys Cortisol III (July 17, 2025)
  • K250768 — Elecsys Anti-SARS-CoV-2 (June 10, 2025)
  • K241453 — Elecsys sFlt-1 and Elecsys PlGF (February 7, 2025)
  • K233060 — Elecsys Folate III (June 17, 2024)
  • K220272 — cobas pulse blood glucose monitoring system (April 26, 2024)

Other clearances for product code MMI

  • K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (October 29, 2025)
  • K243483 — Access hsTnI (August 1, 2025)
  • K242870 — Access hsTnI (June 16, 2025)
  • K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System (January 3, 2025)
  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)
  • K231974 — PATHFAST®hs-cTnI-II (March 20, 2024)
  • K222881 — Access hsTnI (December 18, 2023)
  • K230648 — Access hsTnI (December 4, 2023)
  • K230994 — Alinity i STAT High Sensitivity Troponin-I (May 4, 2023)
  • K202525 — Alinity i STAT High Sensitivity Troponin-I (May 19, 2022)