Cleared Traditional

K013882 - OTI BENZODIAZEPINES INTERCEPT MICRO-PLA...

K013882 is the FDA 510(k) clearance for OTI BENZODIAZEPINES INTERCEPT MICRO-PLA... by OraSure Technologies, Inc.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K013882 · OraSure Technologies, Inc. · Toxicology device
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Apr 2002
Decision
145d
Days
Class 2
Risk

K013882 is an FDA 510(k) clearance for the OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 17, 2002 after a review of 145 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 OraSure Technologies, Inc. devices

Submission Details

510(k) Number K013882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2001
Decision Date April 17, 2002
Days to Decision 145 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
58d slower than avg
Panel avg: 87d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 70
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K013882.
ONLINE DAT BENZODIAZEPINES PLUS
K043327 · Roche Diagnostics Corp. · Feb 2005
BENZODIAZEPINE ENZYME IMMUNOASSAY
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MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
K023048 · Beckman Coulter, Inc. · Nov 2002
BENZODIAZEPINES
K013143 · Abbott Laboratories · Mar 2002
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · ACON Laboratories, Inc. · Sep 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
K003879 · Alfa Scientific Designs, Inc. · May 2001