Cleared Traditional

K093664 - AMPHETAMINES II ASSAY

K093664 is the FDA 510(k) clearance for AMPHETAMINES II ASSAY by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (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

Submission Details

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.

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 Chemistry devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 96
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K093664.
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
K110446 · Roche Diagnostics · May 2011
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
K101745 · Microgenics Corp. · Apr 2011
RANDOX ECSTASY (MDMA) ASSAY
K092275 · Randox Laboratories, Ltd. · Mar 2011
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114 · Microgenics Corp. · May 2010
AMPHETAMINES II
K083764 · Roche Diagnostics Corp. · Feb 2010
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
K062077 · Ortho-Clinical Diagnostics, Inc. · Nov 2006