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Mircoline Screen for Cocaine

by Drug Screening Systems, Inc. 510(k)

Active United States

510(k) K911652

Overview

The MIRCOLINE SCREEN FOR COCAINE is an enzyme immunoassay test system for cocaine and cocaine metabolites. It is classified as a Class II medical device under regulation number 862.3250 and has the product code DIO.

The device received FDA 510(k) clearance (K911652) on May 15, 1991, and is substantially equivalent to a legally marketed device. It is intended for use in clinical toxicology settings and is not exempt if intended for uses other than employment or insurance testing or Federal drug testing programs.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911652 Date15 May 1991ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DIO
Device Class
Class II
Regulation
21 CFR Part 862.3250
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the MIRCOLINE SCREEN FOR COCAINE used for?

    The MIRCOLINE SCREEN FOR COCAINE is an enzyme immunoassay test system designed to detect cocaine and cocaine metabolites in clinical toxicology settings, as specified in its FDA 510(k) clearance documentation.

  • How is the MIRCOLINE SCREEN FOR COCAINE supplied and what is its format?

    The device is supplied as an enzyme immunoassay test system, which typically includes reagents and controls for laboratory-based testing of cocaine and its metabolites in clinical specimens, though specific kit components are not detailed in the provided data.

  • Is the MIRCOLINE SCREEN FOR COCAINE intended for single-use or reuse?

    As an enzyme immunoassay test system, the MIRCOLINE SCREEN FOR COCAINE is designed for in vitro diagnostic use in a laboratory setting, where reagents are consumed during testing and not intended for reuse, consistent with standard clinical laboratory practices for such assays.