Cleared Traditional

K993982 - SYVA EMIT II PLUS AMPHETAMINE/METHAMPHE...

K993982 is the FDA 510(k) clearance for SYVA EMIT II PLUS AMPHETAMINE/METHAMPHE... by Syva Co.. It is a Class 2 Toxicology device (product code LAF) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K993982 · Syva Co. · Toxicology device
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Optimized for regulatory review, auditing and printing
Jan 2000
Decision
64d
Days
Class 2
Risk

K993982 is an FDA 510(k) clearance for the SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 64 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 Syva Co. devices

Submission Details

510(k) Number K993982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date January 27, 2000
Days to Decision 64 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
23d faster than avg
Panel avg: 87d · This submission: 64d
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 31
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K993982.
AT WORK DRUG TEST, MODEL 9147T AWT
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K000096 · Roche Diagnostics Corp. · Apr 2000
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
K000447 · Phamatech · Mar 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