Cleared Traditional

K000458 - URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A

K000458 is an FDA 510(k) clearance for URINE BENZODIAZEPINES (BENZ) SCREEN FLE..., manufactured by Dade Behring, Inc.. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K000458 · Dade Behring, Inc. · Toxicology device
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Apr 2000
Decision
66d
Days
Class 2
Risk

K000458 is an FDA 510(k) clearance for the URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on April 17, 2000 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

FDA 510(k) Submission Details - K000458

510(k) Number K000458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2000
Decision Date April 17, 2000
Days to Decision 66 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
21d faster than avg
Panel avg: 87d · This submission: 66d
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 84
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K000458.
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
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K003881 · Alfa Scientific Designs, Inc. · May 2001
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K011306 · Syva Co., Dade Behring, Inc. · May 2001
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K992720 · American Bio Medica Corp. · 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