Cleared Traditional

K991504 - REDI-TEST METHAMPHETAMINE

K991504 is the FDA 510(k) clearance for REDI-TEST METHAMPHETAMINE by Redwood Biotech, Inc.. It is a Class 2 Toxicology device (product code LAF) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K991504 · Redwood Biotech, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
84d
Days
Class 2
Risk

K991504 is an FDA 510(k) clearance for the REDI-TEST METHAMPHETAMINE. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Redwood Biotech, Inc. (Mountian View, US). The FDA issued a Cleared decision on July 22, 1999 after a review of 84 days - a notably fast clearance 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: 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 Redwood Biotech, Inc. devices

Submission Details

510(k) Number K991504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1999
Decision Date July 22, 1999
Days to Decision 84 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 87d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 32
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K991504.
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982 · Syva Co. · Jan 2000
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
K992634 · Diagnostic Products Corp. · Jan 2000
AT HOME DRUG TEST, MODEL 9068
K994233 · Phamatech · Dec 1999
QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
K972556 · Phamatech · Sep 1997
ACCUSIGN MET/BIOSIGN MET
K961249 · Princeton BioMeditech Corp. · Apr 1996
TENONE(TM) METHAMPHETAMINE
K910043 · Diagnostic Products Corp. · Feb 1991