Cleared Traditional

CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS (K102203) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102203 · Chemtron Biotech, Inc. · Toxicology device
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Jan 2011
Decision
169d
Days
Class 2
Risk

K102203 is an FDA 510(k) clearance for the CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Chemtron Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on January 20, 2011 after a review of 169 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 Chemtron Biotech, Inc. devices

Submission Details

510(k) Number K102203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2010
Decision Date January 20, 2011
Days to Decision 169 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 87d · This submission: 169d
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 Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 78
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K102203.
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AMPHETAMINES II
K083764 · Roche Diagnostics Corp. · Feb 2010
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K053337 · Dade Behring, Inc. · May 2006