Cleared Special

K014024 - MODIFICATION TO ALPHA DX SYSTEM

K014024 is an FDA 510(k) clearance for MODIFICATION TO ALPHA DX SYSTEM, manufactured by First Medical, Inc.. The device is a Class 2 Chemistry device with product code MMI cleared through the Special 510(k) pathway after a 12-day FDA review.

K014024 · First Medical, Inc. · Chemistry device
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Dec 2001
Decision
12d
Days
Class 2
Risk

K014024 is an FDA 510(k) clearance for the MODIFICATION TO ALPHA DX SYSTEM. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by First Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on December 18, 2001 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K014024

510(k) Number K014024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2001
Decision Date December 18, 2001
Days to Decision 12 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 94
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K014024.
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
K020662 · Ortho-Clinical Diagnostics · Apr 2002
SPECTRAL'S TROPONIN I
K014105 · Spectral Diagnostics, Inc. · Feb 2002
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
K013062 · Biocheck, Inc. · Jan 2002
AIA-PACK CTNI 2ND-GEN ASSAY
K012820 · Tosoh Medics, Inc. · Dec 2001
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
K010429 · Beckman Coulter, Inc. · Jun 2001
DIMENSION CTNI FLEX REAGENT CARTRIDGE
K010313 · Dade Behring, Inc. · Apr 2001
K014024 · MODIFICATION TO ALPHA DX SYSTEM
Download PDF First Medical, Inc.