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510(k) K231974

PATHFAST®hs-cTnI-II by Phc Corporation — Product Code MMI

K231974 is an FDA 510(k) premarket notification submitted by Phc Corporation for the device "PATHFAST®hs-cTnI-II". The FDA issued a decision of Substantially Equivalent on March 20, 2024. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2024
Date Received
July 3, 2023
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 for product code MMI

  • K253051 — i-STAT hs-TnI cartridge with the i-STAT Alinity System (June 11, 2026)
  • 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)
  • 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)

FDA data resources