Cleared Special

K061718 - INNOVACON SPECTRUM II TEST CARD

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

K061718 · Innovacon, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K061718

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 87d · This submission: 147d
Pathway characteristics
Modification to existing cleared device.

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 Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 224
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K061718.
AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220
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FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST
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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
ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS
K061005 · Applied Dna Technologies, Inc. · Oct 2006
ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
K060810 · Ind Diagnostic, Inc. · Aug 2006
K061718 · INNOVACON SPECTRUM II TEST CARD
Download PDF FDA Summary Innovacon, Inc.