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510(k) K014105

SPECTRAL'S TROPONIN I by Spectral Diagnostics, Inc. — Product Code MMI

K014105 is an FDA 510(k) premarket notification submitted by Spectral Diagnostics, Inc. for the device "SPECTRAL'S TROPONIN I". The FDA issued a decision of Substantially Equivalent on February 1, 2002. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Spectral Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2002
Date Received
December 13, 2001
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 Spectral Diagnostics, Inc.

  • K052519 — SPECTRAL WEST NILE VIRUS IGM STATUS TEST (November 30, 2006)
  • DEN030002 — ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE (June 16, 2003)
  • K030057 — SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST (March 19, 2003)
  • K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (September 30, 2002)
  • K020950 — SPECTRAL'S 2 IN 1 (TNI-MYO) (May 24, 2002)
  • K992127 — CARDIOQUANT TROPONIN I TEST (October 4, 1999)
  • K991447 — CARDIOQUANT CARDIAC ASSESSMENT CONTROLS (June 11, 1999)
  • K982679 — MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST (October 7, 1998)
  • K981474 — CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) (May 7, 1998)
  • K972687 — CARDIAC STATUS CONTROLS/TROPONIN I (July 28, 1997)

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