ARK Diagnostics - Hydrocodone Assay
ARK Diagnostics, Inc. Announces Launch of FDA 510(k) Cleared ARK Hydrocodone Assay for Qualitative and Semi-Quantitative Detection in Human Urine.

Fremont, California – [7/16/2024] ARK Diagnostics is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted clearance for its Hydrocodone Assay. This assay is designed for the qualitative detection and semi-quantitative estimation of hydrocodone in human urine at a cutoff concentration of 300 ng/mL. The Hydrocodone Assay is intended for use in laboratories equipped with automated clinical chemistry analyzers.
The ARK Hydrocodone Assay offers several key features:
  • Applicable to Many Automated Clinical Chemistry Analyzers: This assay is versatile and compatible with a wide range of automated clinical chemistry analyzers, ensuring broad applicability across various laboratory settings.
  • 0 – 800 ng/mL Semi-Quantitative Calibration Range: The assay provides a semi-quantitative calibration range from 0 to 800 ng/mL, with a Hydrocodone cutoff concentration of 300 ng/mL, enabling precise and accurate detection. The assay detects Hydromorphone almost equivalently to Hydrocodone, meeting the SAMHSA guidelines.
  • High Specificity for Hydrocodone and Hydromorphone: The assay demonstrates high specificity for both hydrocodone and hydromorphone in human urine, ensuring reliable detection of these substances. There is no significant cross-reactivity with other Opioid compounds such as Naloxone, Naltrexone, Oxycodone, Oxymorphone, Morphine, and Codeine.
  • Nonhazardous Preservatives: The assay utilizes nonhazardous preservatives, enhancing safety for laboratory personnel and reducing environmental impact.
The semi-quantitative mode of the assay offers two primary benefits for laboratory use:
  1. Determining Specimen Dilution for Confirmation: This mode enables laboratories to accurately determine the appropriate dilution of the specimen for confirmation by advanced methods, such as Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS).
  2. Establishing Quality Control Procedures: Laboratories can use the semi-quantitative mode to establish rigorous quality control procedures, ensuring the reliability and accuracy of their testing processes.
It is important to note that the Hydrocodone Assay provides only a preliminary analytical test result. For a confirmed positive analytical result, a more specific alternative chemical method must be employed. The preferred confirmatory methods are Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS).

Clinical consideration and professional judgment are crucial when interpreting any drug test result, especially when a preliminary test result is positive. The ARK Hydrocodone Assay aims to support healthcare professionals in making informed decisions by providing reliable preliminary results and facilitating the confirmation process.

ARK Diagnostics - Is a leading innovator in the design, development, manufacturing, and distribution of in vitro diagnostic (IVD) and forensic immunoassays. These assays are crucial for therapeutic drug monitoring, pain management, drugs of abuse detection, and the measurement of other small molecules. Our proprietary assays provide accurate measurements of drug levels in biological fluids.

Contact Information:
ARK Diagnostics, Inc.
48089 Fremont Blvd.
Fremont, California, 94538
877-869-2320
sales@ark-tdm.com
www.ark-tdm.com

For more information about the ARK Hydrocodone Assay, please visit our website or contact our customer service team.
 
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