Cleared Traditional

K991504 - REDI-TEST METHAMPHETAMINE

K991504 is an FDA 510(k) clearance for REDI-TEST METHAMPHETAMINE, manufactured by Redwood Biotech, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K991504

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
Combination Product No
PCCP Authorized No
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.

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 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
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K994233 · Phamatech · Dec 1999
DBEST METHAMPHETAMINES TEST KIT
K983189 · Ameritek, Inc. · Nov 1998
QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
K972556 · Phamatech · Sep 1997
ACCUSIGN MET/BIOSIGN MET
K961249 · Princeton BioMeditech Corp. · Apr 1996