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510(k) K031739

I-STAT CARDIAC TROPONIN (CTNI) TEST by I-Stat Corporation — Product Code MMI

K031739 is an FDA 510(k) premarket notification submitted by I-Stat Corporation for the device "I-STAT CARDIAC TROPONIN (CTNI) TEST". The FDA issued a decision of Substantially Equivalent on September 2, 2003. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. I-Stat Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2003
Date Received
June 4, 2003
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 I-Stat Corporation

  • K053597 — I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) (July 21, 2006)
  • K053110 — Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartri (January 13, 2006)
  • K051433 — I-STAT CREATINE KINASE MB (CK-MB) (December 15, 2005)
  • K031873 — I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VE (October 7, 2003)
  • K023582 — I-STAT KAOLIN ACT TEST (September 8, 2003)
  • K020355 — I-STAT PROTHROMBIN TIME TEST (May 14, 2002)

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)
  • 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)

FDA data resources