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Screeners Barbiturate Test Dip

by Drug Detection Devices, Ltd. 510(k)

Active United States

510(k) K000522

Overview

This device is an enzyme immunoassay for the qualitative detection of barbiturates in biological specimens, including urine, serum, and gastric contents. It functions as a screening tool to identify the presence of barbiturate drugs, aiding in the diagnosis of overdose, monitoring therapeutic levels, and guiding clinical management in toxicology settings.

The Screeners Barbiturate Test Dip is supplied as a single-use, non-sterile diagnostic test intended for use in clinical toxicology laboratories. It is classified as a Class II device under FDA regulations (862.3150) and received FDA 510(k) clearance as substantially equivalent to a predicate device. The test requires no special storage conditions beyond those specified in the instructions for use and is designed for professional use only.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000522 Date18 Apr 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • 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)

Full name
Screeners Barbiturate Test, Drugscreen Dip Barbiturate Test
510(k) Number
FDA Product Code
DIS
Device Class
Class II
Regulation
21 CFR Part 862.3150
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What types of biological specimens can this barbiturate test detect, and how is it intended to be used in clinical settings?

    The Screeners Barbiturate Test Dip is designed for the qualitative detection of barbiturates in urine, serum, and gastric contents. It serves as a screening tool in clinical toxicology to help identify potential barbiturate exposure, assist in diagnosing overdoses, monitor therapeutic levels, and guide clinical management decisions. It is intended for professional use only in clinical toxicology laboratories.

  • Is this test single-use or reusable, and what are the storage requirements?

    This test is supplied as a single-use, non-sterile device. Storage requirements are minimal and are detailed in the instructions for use, meaning no special conditions are needed beyond what is specified there. It is not intended for reuse.

  • What regulatory pathway was followed for FDA clearance, and what does this mean for its use in clinical toxicology?

    The Screeners Barbiturate Test received FDA 510(k) clearance through a traditional review process, determined to be substantially equivalent to a predicate device. This means the device was evaluated by the FDA as meeting the same performance criteria as an existing, legally marketed device, ensuring its safety and effectiveness for use in clinical toxicology settings as described in the device data.

  • Are there different sizes or models available for this barbiturate test, and how would I identify them?

    The provided data does not specify distinct sizes or models beyond the general description of the Screeners Barbiturate Test Dip. All references point to a single device type, so there are no variations in sizes or models listed. The device is identified by its registration numbers and product code (DIS) in the FDA database.