Cleared Traditional

K093664 - AMPHETAMINES II ASSAY

K093664 is an FDA 510(k) clearance for AMPHETAMINES II ASSAY, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code DKZ cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K093664 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
243d
Days
Class 2
Risk

K093664 is an FDA 510(k) clearance for the AMPHETAMINES II ASSAY. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 28, 2010 after a review of 243 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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K093664

510(k) Number K093664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2009
Decision Date July 28, 2010
Days to Decision 243 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 88d · This submission: 243d
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 156
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K093664.
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LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY
K102210 · Lin-Zhi International, Inc. · Dec 2010
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114 · Microgenics Corp. · May 2010
AMPHETAMINES II
K083764 · Roche Diagnostics Corp. · Feb 2010
MEDTOXSCAN
K080635 · Medtox Diagnostics, Inc. · Feb 2009