Cleared Traditional

K992127 - CARDIOQUANT TROPONIN I TEST

K992127 is an FDA 510(k) clearance for CARDIOQUANT TROPONIN I TEST, manufactured by Spectral Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K992127 · Spectral Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
103d
Days
Class 2
Risk

K992127 is an FDA 510(k) clearance for the CARDIOQUANT TROPONIN I TEST. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Spectral Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on October 4, 1999 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectral Diagnostics, Inc. devices

FDA 510(k) Submission Details - K992127

510(k) Number K992127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1999
Decision Date October 04, 1999
Days to Decision 103 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 88d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMI Device Classification - Class 2, Special Controls

Product Code MMI Immunoassay Method, Troponin Subunit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - MMI Immunoassay Method, Troponin Subunit

All 77
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K992127.
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
K993309 · Bayer Corp. · Dec 1999
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
K993353 · Bayer Corp. · Dec 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
K992366 · Ortho-Clinical Diagnostics, Inc. · Oct 1999
OPUS TROPONIN I (CTN) TEST MODULES
K991177 · Dade Behring, Inc. · Jul 1999
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
K991795 · Diagnostic Products Corp. · Jun 1999
AIA-PACK TROPONIN I ASSAY
K984359 · Tosoh Medics, Inc. · Dec 1998