Cleared Traditional

K023946 - ACON ONE STEP MULTI-DRUG MULTI-LINE SCR...

K023946 is the FDA 510(k) clearance for ACON ONE STEP MULTI-DRUG MULTI-LINE SCR... by ACON Laboratories, Inc.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K023946 · ACON Laboratories, Inc. · Toxicology device
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Feb 2003
Decision
70d
Days
Class 2
Risk

K023946 is an FDA 510(k) clearance for the ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRU.... 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 February 5, 2003 after a review of 70 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 K023946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2002
Decision Date February 05, 2003
Days to Decision 70 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
17d faster than avg
Panel avg: 87d · This submission: 70d
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 K023946.
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
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT)
K032764 · Lin-Zhi International, Inc. · Nov 2003
BARBITURATES
K012996 · Abbott Laboratories · Mar 2002
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