Thermo Fisher Scientific has received 510(k) approval from the US Food and Drug Administration (FDA) for its new immunoassay to specifically detect hydrocodone.
The semi-synthetic opioid hydrocodone is an antitussive (cough suppressant) and narcotic analgesic agent that can be used to treat moderate to severe pain.
The DRI Hydrocodone assay is a homogeneous enzyme immunoassay, which specifically detects hydrocodone at the 300ng/mL cut-off. It has better cross-reactivity with the major metabolites hydromorphone and hydromorphone-glucuronide.
With enhanced specificity and sensitivity, the assay is an easy-to-use screening tool for hydrocodone in urine samples with applications for a variety of clinical chemistry analyzers.
The assay uses liquid and ready-to-use reagents that can be run in both qualitative and semi-quantitative modes.
According to the firm, hydrocodone is considered to be one of the most frequently prescribed and misused opiate drugs in the US.
In September this year, the firm obtained in vitro diagnostics device (IVDD) CE mark approval for its Prelude MD HPLC, Endura MD mass spectrometer and ClinQuan MD software.
Clinical laboratories can access the high-performance liquid chromatograph, mass spectrometer and LC-MS software for in vitro diagnostic use in analyzing patient samples as components of laboratory-developed tests.
Image: Thermo Fisher Scientific has obtained FDA 510(k) approval for DRI Hydrocodone assay. Photo: courtesy of Thermo Fisher Scientific Inc.