Cleared Traditional

K003847 - MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)

K003847 is an FDA 510(k) clearance for MODIFICATION TO INSTANT-VIEW METHAMPHET..., manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Toxicology device with product code LAF cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K003847 · Alfa Scientific Designs, Inc. · Toxicology device
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May 2001
Decision
168d
Days
Class 2
Risk

K003847 is an FDA 510(k) clearance for the MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE). Classified as Gas Chromatography, Methamphetamine (product code LAF), 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 168 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 - K003847

510(k) Number K003847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2000
Decision Date May 29, 2001
Days to Decision 168 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
81d slower than avg
Panel avg: 87d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAF Device Classification - Class 2, Special Controls

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAF Gas Chromatography, Methamphetamine

All 39
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K003847.
AMPHETAMINE/METHAMPHETAMINE
K012998 · Abbott Laboratories · Mar 2002
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
K011672 · ACON Laboratories, Inc. · Jul 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)
K003845 · Alfa Scientific Designs, Inc. · May 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496 · Microgenics Corp. · May 2001
AT WORK DRUG TEST, MODEL 9147T AWT
K010836 · Phamatech · Apr 2001
FIRST CHECK HOME DRUG TEST PANEL 4
K993852 · Worldwide Medical Corp. · Nov 2000