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Scooper Drug/Adulteration Test Cup Modification

by Branan Medical Corp. 510(k)

Active United States

510(k) K013124

Overview

The Scooper Drug/Adulteration Test Cup Modification is an in vitro diagnostic device designed for urine drug screening. It incorporates integrated test strips for detecting morphine, amphetamines, tetrahydrocannabinol (THC), cocaine metabolite, and phencyclidine, alongside reagent pads for adulteration testing, including creatinine, nitrite, pH, and oxidizing agents. This device falls under the classification of fluorometry-based diagnostic tools, specifically regulated under 21 CFR 862.3640.

This modification is intended for single-use in clinical toxicology settings, such as laboratories or emergency departments, to detect illicit substances and potential adulterants in urine samples. Supplied as a sterile, ready-to-use kit, it requires no additional preparation beyond following the manufacturer’s instructions. The device holds FDA 510(k) clearance (K013124) under a Special review pathway, with a classification of Class II (DJJ). Storage conditions and regulatory compliance are governed by the applicable FDA guidelines for in vitro diagnostics.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK013124 Date7 Nov 2001ClearedStatusActive

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  • Withdrawn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 5 Oct 2026.

Specification

510(k)

Full name
Modification to Scooper Drug/Adulteration Test Cup
510(k) Number
FDA Product Code
DJJ
Device Class
Class II
Regulation
21 CFR Part 862.3640
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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