Cleared Special

K001197 - COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA

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

K001197 · OraSure Technologies, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K001197

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 87d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DIO Device Classification - Class 2, Special Controls

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 144
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K001197.
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INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST
K994403 · Alfa Scientific Designs, Inc. · Aug 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
K994398 · Alfa Scientific Designs, Inc. · Jul 2000
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000467 · Dade Behring, Inc. · Apr 2000
SCREENERS COCAINE TEST
K000350 · Drug Detection Devices, Ltd. · Apr 2000
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
K994165 · Roche Diagnostics Corp. · Apr 2000
K001197 · COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
Download PDF FDA Summary OraSure Technologies,…