Amedicheck Drug Screen THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZ

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

510(k) Number

K080872 ↗

FDA Product Code

LDJ

Device Class

Class II

Regulation

21 CFR Part 862.3870

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Amedica Drug Screen Test Cup

  Class II

  FDA 510(k) K082898 Active Cleared 19 Dec 2008

• 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

See all devices from Amedica Biotech, Inc. →

• What types of drugs can the Amedicheck Drug Screen detect in a urine sample?

  The Amedicheck Drug Screen is designed to qualitatively detect metabolites of nine different drug classes in human urine: THC (cannabinoids), cocaine (COC), opioids (OPI), amphetamines (AMP), methamphetamine (MET), phencyclidine (PCP), benzodiazepines (BZ), barbiturates (BAR), and MDMA. It uses a multi-panel enzyme immunoassay format to simultaneously screen for these substances at specified cutoff concentrations.

• How is the Amedicheck Drug Screen supplied, and is it intended for single-use?

  The Amedicheck Drug Screen is supplied as a single-use, non-sterile test kit. Each kit is intended for one-time use in a clinical toxicology setting, where a urine specimen is added to the test cup to produce a visual result within minutes. This design ensures no risk of cross-contamination between patients.

• What kind of storage conditions are required for the Amedicheck Drug Screen?

  The device does not require any special storage conditions, such as refrigeration or controlled humidity. It can be stored at room temperature, making it convenient for point-of-care use in clinical settings where refrigeration may not always be available.

• How long does it take to get results from the Amedicheck Drug Screen?

  The Amedicheck Drug Screen provides results within minutes of adding the urine specimen to the test cup. This rapid turnaround is ideal for immediate screening in clinical toxicology settings, allowing for quick decision-making.

• What is the regulatory pathway for the Amedicheck Drug Screen, and how was it classified?

  The Amedicheck Drug Screen received FDA clearance through a 510(k) submission, specifically classified as a Class II medical device under the FDA’s regulations. The device was determined to be substantially equivalent to a predicate product and was reviewed by the Clinical Toxicology Advisory Committee. The product code assigned is LDJ, and it falls under the regulation number 862.3870.