Cleared Traditional

K003647 - INSTANT-VIEW BARBITURATE URINE CASSETTE TEST

K003647 is an FDA 510(k) clearance for INSTANT-VIEW BARBITURATE URINE CASSETTE..., manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K003647 · Alfa Scientific Designs, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
183d
Days
Class 2
Risk

K003647 is an FDA 510(k) clearance for the INSTANT-VIEW BARBITURATE URINE CASSETTE TEST. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), 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 183 days - an extended review 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: 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

FDA 510(k) Submission Details - K003647

510(k) Number K003647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2000
Decision Date May 29, 2001
Days to Decision 183 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
96d slower than avg
Panel avg: 87d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K003647.
BARBITURATES
K012996 · Abbott Laboratories · Mar 2002
VISUALINE BARBITURATES DIPSTRIP TEST
K020136 · Sun Biomedical Laboratories, Inc. · Mar 2002
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
K012824 · ACON Laboratories, Inc. · Nov 2001
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
K010125 · Alfa Scientific Designs, Inc. · May 2001
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
K010934 · Syva Co., Dade Behring, Inc. · Apr 2001
VERDICT -II BAR
K010959 · Medtox Diagnostics, Inc. · Apr 2001