Cleared Traditional

K101745 - THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY

K101745 is an FDA 510(k) clearance for THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT..., manufactured by Microgenics Corp.. The device is a Class 2 Chemistry device with product code DKZ cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K101745 · Microgenics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
290d
Days
Class 2
Risk

K101745 is an FDA 510(k) clearance for the THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT 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 April 8, 2011 after a review of 290 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

FDA 510(k) Submission Details - K101745

510(k) Number K101745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2010
Decision Date April 08, 2011
Days to Decision 290 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
202d slower than avg
Panel avg: 88d · This submission: 290d
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 184
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K101745.
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AMPHETAMINES II ASSAY
K093664 · Roche Diagnostics Corp. · Jul 2010