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STC Cocaine Metabolite Micro-Plate EIA (OraSure Device)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K982061

by OraSure Technologies, Inc.

Identifiers

510(k) Number
K982061 FDA 510(k)
FDA Product Code
DIO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3250 FDA 510(k)
Regulation Number
862.3250 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The STC Cocaine Metabolite Micro-Plate EIA (OraSure Device) is an in vitro diagnostic enzyme immunoassay for the qualitative determination of cocaine and cocaine metabolites in oral fluid. It is classified as an Enzyme Immunoassay, Cocaine And Cocaine Metabolites under regulation number 862.3250 and product code DIO.

The device is supplied for use with the OraSure® Oral Specimen Collection Device for sample collection. It received FDA 510(k) clearance (K982061) on August 25, 1998, as substantially equivalent to a predicate device, and is intended for use in clinical toxicology settings.

Frequently asked questions

What is the STC Cocaine Metabolite Micro-Plate EIA (OraSure Device) used for?

It is an in vitro diagnostic enzyme immunoassay designed for the qualitative determination of cocaine and cocaine metabolites in oral fluid specimens, intended for use in clinical toxicology settings to support screening for recent cocaine use.

How is the STC Cocaine Metabolite Micro-Plate EIA (OraSure Device) supplied and what is required for sample collection?

The device is supplied as a micro-plate enzyme immunoassay kit and is intended for use with the OraSure® Oral Specimen Collection Device, which must be used to collect oral fluid samples prior to testing; the collection device is not included in the EIA kit and must be obtained separately.

Is the STC Cocaine Metabolite Micro-Plate EIA (OraSure Device) reusable or single-use?

The assay is designed for single-use testing of individual specimens; each well in the micro-plate is intended for one sample, and reagents are formulated for one-time use to ensure accurate and reliable qualitative results, with reuse not supported by the device design or labeling.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stc Cocaine Metabolite Micro-plate Eia (Orasure Device), FDA Browser - Cleared 510 (K) - STC COCAINE METABOLITE MICRO-PLATE EIA ..., Stc Cocaine Metabolite Micro-plate Eia 510 (k) FDA Premarket ..., STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) 510 (k) K982061 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
OraSure Technologies, Inc.

Sources (1)

  • FDA 510(k) K982061 24 fields · synced Sep 21, 2026