Cleared Traditional

K102203 - CHEMTRUE SINGLE / MULTI DRUG SCREEN CAS...

K102203 is an FDA 510(k) clearance for CHEMTRUE SINGLE / MULTI DRUG SCREEN CAS..., manufactured by Chemtron Biotech, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 169-day FDA review.

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

FDA 510(k) Submission Details - K102203

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.

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 Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 141
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K102203.
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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
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114 · Microgenics Corp. · May 2010