Cleared Traditional

K993208 - STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I

K993208 is an FDA 510(k) clearance for STC METHAMPHETAMINE INTERCEPT MICRO-PLA..., manufactured by OraSure Technologies, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K993208

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
Combination Product No
PCCP Authorized No
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.

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 K993208.
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