Cleared Traditional

K093114 - THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY

K093114 is the FDA 510(k) clearance for THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY by Microgenics Corp.. It is a Class 2 Chemistry device (product code DKZ) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K093114 · Microgenics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
223d
Days
Class 2
Risk

K093114 is an FDA 510(k) clearance for the THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on May 12, 2010 after a review of 223 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 Microgenics Corp. devices

Submission Details

510(k) Number K093114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2009
Decision Date May 12, 2010
Days to Decision 223 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
135d slower than avg
Panel avg: 88d · This submission: 223d
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 125
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K093114.
RANDOX ECSTASY (MDMA) ASSAY
K092275 · Randox Laboratories, Ltd. · Mar 2011
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY
K102210 · Lin-Zhi International, Inc. · Dec 2010
AMPHETAMINES II ASSAY
K093664 · Roche Diagnostics Corp. · Jul 2010
AMPHETAMINES II
K083764 · Roche Diagnostics Corp. · Feb 2010
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