Cleared Traditional

K042227 - INSTANT-VIEW TROPONIN I TEST

K042227 is the FDA 510(k) clearance for INSTANT-VIEW TROPONIN I TEST by Alfa Scientific Designs, Inc.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K042227 · Alfa Scientific Designs, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
94d
Days
Class 2
Risk

K042227 is an FDA 510(k) clearance for the INSTANT-VIEW TROPONIN I TEST. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on November 19, 2004 after a review of 94 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 Alfa Scientific Designs, Inc. devices

Submission Details

510(k) Number K042227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2004
Decision Date November 19, 2004
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 88d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 68
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K042227.
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
K053020 · Bayer Healthcare, LLC · Dec 2005
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
K052503 · Bayer Healthcare, LLC · Dec 2005
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
K051752 · Roche Diagnostics · Jul 2005
ABBOTT AXSYM TROPONIN-I ADV
K041811 · Abbott Laboratories · Sep 2004
ELECSYS TROPONIN T STAT TEST
K040733 · Roche Diagnostics Corp. · May 2004
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
K033487 · Dade Behring, Inc. · Dec 2003