Cleared Traditional

K003881 - INSTANT-VIEW BENZODIAZEPINE (BZD) URINE...

K003881 is the FDA 510(k) clearance for INSTANT-VIEW BENZODIAZEPINE (BZD) URINE... by Alfa Scientific Designs, Inc.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K003881 · Alfa Scientific Designs, Inc. · Toxicology device
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May 2001
Decision
165d
Days
Class 2
Risk

K003881 is an FDA 510(k) clearance for the INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on May 29, 2001 after a review of 165 days - an extended review cycle.

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 Alfa Scientific Designs, Inc. devices

Submission Details

510(k) Number K003881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2000
Decision Date May 29, 2001
Days to Decision 165 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 87d · This submission: 165d
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 69
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K003881.
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
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458 · Dade Behring, Inc. · Apr 2000
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
K993985 · Syva Co. · Jan 2000
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
K991443 · Roche Diagnostics Corp. · Jun 1999