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Rapidone-Amphetamine Test

by American Bio Medica Corp.

510(k) K992452

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992452 Date18 Oct 1999ClearedStatusActive

Official records

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  • Withdrawn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
DOD
Device class
Class II
Regulation
21 CFR Part 862.3100
Advisory committee
Clinical Toxicology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

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

The Rapidone Amphetamine Test is a qualitative immunoassay device for the detection of d-amphetamine in human urine, classified under Gas Chromatography, Amphetamine (Product Code DOD). It employs a lateral flow membrane strip with immobilized monoclonal anti-amphetamine antibodies and a reagent pad containing a colloidal gold-BSA-amphetamine conjugate to facilitate one-step testing.

This single-use, non-sterile device is intended for use in clinical toxicology settings, such as emergency departments or forensic laboratories. Supplied as a portable test kit, it requires no specialized equipment beyond basic handling and interpretation of visual results. The device carries an FDA 510(k) clearance (K992452) under Class II regulatory controls, with no additional sterility or MRI safety considerations specified.

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