Cleared Traditional

K080057 - IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL

K080057 is an FDA 510(k) clearance for IMDX ANALYZER, manufactured by Novx Systems, Inc.. The device is a Class 2 Chemistry device with product code DKZ cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K080057 · Novx Systems, Inc. · Chemistry device
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Oct 2008
Decision
296d
Days
Class 2
Risk

K080057 is an FDA 510(k) clearance for the IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP C.... Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Novx Systems, Inc. (Rockville, US). The FDA issued a Cleared decision on October 31, 2008 after a review of 296 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - 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 Novx Systems, Inc. devices

FDA 510(k) Submission Details - K080057

510(k) Number K080057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2008
Decision Date October 31, 2008
Days to Decision 296 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 88d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 159
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K080057.
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114 · Microgenics Corp. · May 2010
AMPHETAMINES II
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MEDTOXSCAN
K080635 · Medtox Diagnostics, Inc. · Feb 2009
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
K062077 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS
K063024 · Lin-Zhi International, Inc. · Oct 2006
RAPIDTOX
K053359 · American Bio Medica Corp. · May 2006