Cleared Traditional

K993208 - STC METHAMPHETAMINE INTERCEPT MICRO-PLA...

K993208 is the FDA 510(k) clearance for STC METHAMPHETAMINE INTERCEPT MICRO-PLA... by OraSure Technologies, Inc.. It is a Class 2 Toxicology device (product code LAF) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K993208 · OraSure Technologies, Inc. · Toxicology device
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Apr 2000
Decision
192d
Days
Class 2
Risk

K993208 is an FDA 510(k) clearance for the STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 3, 2000 after a review of 192 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 OraSure Technologies, Inc. devices

Submission Details

510(k) Number K993208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1999
Decision Date April 03, 2000
Days to Decision 192 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
105d slower than avg
Panel avg: 87d · This submission: 192d
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 K993208.
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496 · Microgenics Corp. · May 2001
AT WORK DRUG TEST, MODEL 9147T AWT
K010836 · Phamatech · Apr 2001
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096 · Roche Diagnostics Corp. · Apr 2000
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
K000447 · Phamatech · Mar 2000
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