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510(k) K253051

i-STAT hs-TnI cartridge with the i-STAT Alinity System by Abbott Point of Care, Inc. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2026
Date Received
September 22, 2025
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 Abbott Point of Care, Inc.

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  • K234143 — i-STAT TBI Cartridge with the i-STAT Alinity System (March 27, 2024)
  • K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K230300 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K223857 — i-STAT G3+ cartridge with the i-STAT 1 System (September 15, 2023)
  • K223755 — i-STAT G cartridge with the i-STAT 1 System (September 11, 2023)
  • K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System (July 28, 2023)
  • K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (August 13, 2021)

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)