Cleared Traditional

K061005 - ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS

K061005 is an FDA 510(k) clearance for ACCUSTEP DOA SINGLE AND MULTI-STRIP SCR..., manufactured by Applied Dna Technologies, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K061005 · Applied Dna Technologies, Inc. · Toxicology device
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Oct 2006
Decision
176d
Days
Class 2
Risk

K061005 is an FDA 510(k) clearance for the ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Applied Dna Technologies, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on October 4, 2006 after a review of 176 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Dna Technologies, Inc. devices

FDA 510(k) Submission Details - K061005

510(k) Number K061005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2006
Decision Date October 04, 2006
Days to Decision 176 days
Submission Type Traditional
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
89d slower than avg
Panel avg: 87d · This submission: 176d
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 Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 195
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