Cleared Special

K001197 - COCAINE METABOLITE INTERCEPT MICRO-PLAT...

K001197 is the FDA 510(k) clearance for COCAINE METABOLITE INTERCEPT MICRO-PLAT... by OraSure Technologies, Inc.. It is a Class 2 Toxicology device (product code DIO) cleared through the Special 510(k) pathway after a 30-day FDA review.

K001197 · OraSure Technologies, Inc. · Toxicology device
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May 2000
Decision
30d
Days
Class 2
Risk

K001197 is an FDA 510(k) clearance for the COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 11, 2000 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all OraSure Technologies, Inc. devices

Submission Details

510(k) Number K001197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2000
Decision Date May 11, 2000
Days to Decision 30 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 87d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 83
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