Cleared Special

K010562 - ALPHA DX SYSTEM

K010562 is an FDA 510(k) clearance for 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 15-day FDA review.

K010562 · First Medical, Inc. · Chemistry device
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Mar 2001
Decision
15d
Days
Class 2
Risk

K010562 is an FDA 510(k) clearance for the 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 March 13, 2001 after a review of 15 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.

View all First Medical, Inc. devices

FDA 510(k) Submission Details - K010562

510(k) Number K010562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2001
Decision Date March 13, 2001
Days to Decision 15 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
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 79
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K010562.
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
BAYER ADVIA IMS SYSTEM
K010201 · Bayer Corp. · Mar 2001
THE CARDIAC READER SYSTEM
K000784 · Roche Diagnostics Corp. · May 2000
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