Cleared Traditional

K111322 - CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN...

K111322 is an FDA 510(k) clearance for CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN..., manufactured by Chemtron Biotech, Inc.. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K111322 · Chemtron Biotech, Inc. · Toxicology device
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Sep 2011
Decision
126d
Days
Class 2
Risk

K111322 is an FDA 510(k) clearance for the CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Chemtron Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on September 14, 2011 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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 - K111322

510(k) Number K111322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2011
Decision Date September 14, 2011
Days to Decision 126 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
39d slower than avg
Panel avg: 87d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXM Device Classification - Class 2, Special Controls

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 76
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