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Visualine Amphetamine Dipstrip Assay

by Sun Biomedical Laboratories, Inc.

510(k) K011499

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011499 Date17 Jul 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DKZ
Device Class
Class II
Regulation
21 CFR Part 862.3100
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

This device received FDA 510(k) clearance under K011499 and is classified as a Class II device with product code DKZ. It is supplied by Sun Biomedical Laboratories, Inc. and is intended for use in clinical toxicology settings.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the VISUALINE AMPHETAMINE DIPSTRIP ASSAY used for?

    The VISUALINE AMPHETAMINE DIPSTRIP ASSAY is intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

  • How is the VISUALINE AMPHETAMINE DIPSTRIP ASSAY supplied and intended for use?

    The device is supplied by Sun Biomedical Laboratories, Inc. and is intended for use in clinical toxicology settings. It is a dipstrip assay designed for qualitative or semi-quantitative detection of amphetamine in biological specimens such as plasma and urine.

  • What regulatory pathway was used for the VISUALINE AMPHETAMINE DIPSTRIP ASSAY?

    The device received FDA 510(k) clearance under K011499, indicating it was found substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device with product code DKZ.