Cleared Special

K061718 - INNOVACON SPECTRUM II TEST CARD

K061718 is the FDA 510(k) clearance for INNOVACON SPECTRUM II TEST CARD by Innovacon, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Special 510(k) pathway after a 147-day FDA review.

K061718 · Innovacon, Inc. · Toxicology device
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Nov 2006
Decision
147d
Days
Class 2
Risk

K061718 is an FDA 510(k) clearance for the INNOVACON SPECTRUM II TEST CARD. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Innovacon, Inc. (San Diego, US). The FDA issued a Cleared decision on November 13, 2006 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Innovacon, Inc. devices

Submission Details

510(k) Number K061718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2006
Decision Date November 13, 2006
Days to Decision 147 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 87d · This submission: 147d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 126
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K061718.
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
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K063024 · Lin-Zhi International, Inc. · Oct 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337 · Dade Behring, Inc. · May 2006
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K051579 · Immunalysis Corporation · Oct 2005