Cleared Traditional

K994400 - INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST

K994400 is an FDA 510(k) clearance for INSTANT-VIEW METHAMPHETAMINE URINE CASS..., manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Toxicology device with product code DJC cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K994400 · Alfa Scientific Designs, Inc. · Toxicology device
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Aug 2000
Decision
220d
Days
Class 2
Risk

K994400 is an FDA 510(k) clearance for the INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST. Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (San Diego, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 220 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 - K994400

510(k) Number K994400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date August 04, 2000
Days to Decision 220 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
133d slower than avg
Panel avg: 87d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJC Device Classification - Class 2, Special Controls

Product Code DJC Thin Layer 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 - DJC Thin Layer Chromatography, Methamphetamine

All 19
Devices cleared under the same product code (DJC) and FDA review panel - the closest regulatory comparables to K994400.
RAPIDONE-ECSTASY TEST
K013180 · American Bio Medica Corp. · Nov 2001
VERDICT -II METHAMPHETAMINE
K010226 · Medtox Diagnostics, Inc. · Jun 2001
INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
K994406 · Alfa Scientific Designs, Inc. · Aug 2000
ONTRAK TESTCUP PRO-5, MODEL 1986678
K001356 · Roche Diagnostics Corp. · Jul 2000
REDI-SCREEN
K993100 · Redwood Biotech, Inc. · Oct 1999
DIALYSIS SYS., PDS 400 & RO 400
K781156 · Physio-Control Corp. · Oct 1978