Amedica Drug Screen Test Cup

• • Terminated Z-0270-2019 FDA Class III ·initiated 30 Sep 2017 ·on shared 510(k) K082898

  Product was released to market without the adulteration strip included in the product.

• • Terminated Z-2311-2016 FDA Class III ·initiated 5 Jul 2016 ·on shared 510(k) K082898

  Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K082898 ↗

FDA Product Code

NGL

Device Class

Class II

Regulation

21 CFR Part 862.3650

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Amedica Drug Screen Phencyclidine Test

  Unclassified

  FDA 510(k) K023109 Active Cleared 16 Dec 2002

• Amedica Drug Screen Mdma-Bar-Bzo-Mtd-Tca Test

  Class II

  FDA 510(k) K031497 Active Cleared 17 Oct 2003

• Amedica Drug Test Thc, Coc, Opi, Amp, Met, Pcp, Bar, Bzo, Mdma, Oxy, Tca

  Class II

  FDA 510(k) K100108 Active Cleared 14 Apr 2010

• Amedica Drug Screen Cocaine Test

  Class II

  FDA 510(k) K022954 Active Cleared 6 Nov 2002

• Amedica Drug Screen Methaphetamine Test

  Class II

  FDA 510(k) K023101 Active Cleared 16 Dec 2002

• Amedica Drug Screen Thc Test

  Class II

  FDA 510(k) K022955 Active Cleared 6 Nov 2002

See all devices from Amedica Biotech, Inc. →

• What substances does the Amedica Drug Screen Test Cup detect in urine samples, and how does it work?

  The Amedica Drug Screen Test Cup uses lateral flow immunoassay technology to rapidly and qualitatively detect multiple drugs of abuse in human urine, including opiates, cocaine, THC, amphetamines, methamphetamines, PCP, MDMA, barbiturates, and benzodiazepines. It provides a simple, no-prep solution by requiring only the introduction of a urine sample into the sterile, ready-to-use cup for results.

• Is the Amedica Drug Screen Test Cup intended for single-use or reusable applications?

  The Amedica Drug Screen Test Cup is explicitly designed for single-use only. Each cup is sterile and ready-to-use, eliminating the need for preparation or reuse, which helps ensure accuracy and prevent cross-contamination in clinical toxicology settings.

• How should the Amedica Drug Screen Test Cup be stored, and does it require any special handling?

  While the device is supplied sterile and ready-to-use, storage conditions are not explicitly detailed in the provided data. However, as a single-use, over-the-counter diagnostic tool, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until use.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Amedica Drug Screen Test Cup received FDA 510(k) clearance (K082898) under the Traditional 510(k) review pathway, demonstrating substantial equivalence to a predicate device. This clearance confirms compliance with FDA standards for in vitro diagnostic devices classified as Class II, ensuring its suitability for clinical toxicology applications as intended.