Cleared Traditional

K972989 - STC METHAMPHETAMINE MICRO-PLATE EIA

K972989 is the FDA 510(k) clearance for STC METHAMPHETAMINE MICRO-PLATE EIA by OraSure Technologies, Inc.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K972989 · OraSure Technologies, Inc. · Toxicology device
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Jan 1998
Decision
169d
Days
Class 2
Risk

K972989 is an FDA 510(k) clearance for the STC METHAMPHETAMINE MICRO-PLATE EIA. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on January 28, 1998 after a review of 169 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 K972989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1997
Decision Date January 28, 1998
Days to Decision 169 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 87d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 126
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K972989.
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ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
K972891 · Roche Diagnostic Systems, Inc. · Oct 1997