Cleared Traditional

K000522 - SCREENERS BARBITURATE TEST

K000522 is the FDA 510(k) clearance for SCREENERS BARBITURATE TEST by Drug Detection Devices, Ltd.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K000522 · Drug Detection Devices, Ltd. · Toxicology device
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Apr 2000
Decision
62d
Days
Class 2
Risk

K000522 is an FDA 510(k) clearance for the SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Drug Detection Devices, Ltd. (Alpharetta, US). The FDA issued a Cleared decision on April 18, 2000 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 Drug Detection Devices, Ltd. devices

Submission Details

510(k) Number K000522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2000
Decision Date April 18, 2000
Days to Decision 62 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
25d faster than avg
Panel avg: 87d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 68
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K000522.
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
K012824 · ACON Laboratories, Inc. · Nov 2001
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
K003647 · Alfa Scientific Designs, Inc. · May 2001
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
K010125 · Alfa Scientific Designs, Inc. · May 2001
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
K000459 · Dade Behring, Inc. · Apr 2000
ROCHE COBAS INTEGRA SERUM BARBITURATES
K991440 · Roche Diagnostics Corp. · Jun 1999
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
K983698 · Roche Diagnostic Systems, Inc. · May 1999