Cleared Traditional

K050593 - ACON BAR II ONE STEP BARBITURATES TEST ...

K050593 is the FDA 510(k) clearance for ACON BAR II ONE STEP BARBITURATES TEST ... by ACON Laboratories, Inc.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K050593 · ACON Laboratories, Inc. · Toxicology device
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May 2005
Decision
59d
Days
Class 2
Risk

K050593 is an FDA 510(k) clearance for the ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on May 6, 2005 after a review of 59 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 ACON Laboratories, Inc. devices

Submission Details

510(k) Number K050593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2005
Decision Date May 06, 2005
Days to Decision 59 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
28d faster than avg
Panel avg: 87d · This submission: 59d
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 67
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K050593.
RANDOX BARITURATES ASSAY
K092268 · Randox Laboratories, Ltd. · May 2011
VITROS CHEMISTRY PRODUCTS BARB REAGENT
K062165 · Ortho-Clinical Diagnostics · Jan 2007
ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
K050024 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2005
ONLINE DAT BARBITURATES PLUS
K043211 · Roche Diagnostics Corp. · Dec 2004
RANDOX BARBITURATE ASSAY
K041143 · Randox Laboratories, Ltd. · Nov 2004
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885 · Lin-Zhi International, Inc. · May 2004