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Thermo Fisher Scientific Inc.. (10/27/15). "Press Release: New Immunoassay for the Specific Detection of Hydrocodone Receives FDA 510 (k) Clearance". Fremont, CA.

Region Region United States (USA)
Organisations Organisation Thermo Fisher Scientific Inc. (NYSE: TMO)
  Group Thermo Fisher (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Person Person Ruzich, Kathy (Thermo Fisher 201510)

Thermo Scientific DRI Hydrocodone Assay meets newly proposed SAMHSA guidelines

A new immunoassay for specific detection of hydrocodone has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA).

The Thermo Scientific DRI Hydrocodone Assay has the requisite sensitivities to meet the newly proposed Substance Abuse and Mental Health Administration (SAMHSA) guidelines (using a 300 ng/mL cut-off). SAMHSA oversees the testing of federally regulated employees and many organizations follow the guidelines set-forth by this agency.

The DRI Hydrocodone Assay is a homogeneous enzyme immunoassay that specifically detects hydrocodone at the 300 ng/mL cut-off and has excellent cross-reactivity to the major metabolites hydromorphone and hydromorphone-glucuronide. The assay utilizes liquid, ready-to-use reagents, which can be run in both qualitative and semi-quantitative modes. Calibrators and controls are sold separately.

The DRI Hydrocodone Assay demonstrates good correlation with LC-MS/MS and has excellent assay precision. It has excellent specificity and sensitivity, making it an easy-to-use screening tool for hydrocodone in urine samples with applications for a variety of clinical chemistry analyzers.

Some of the traditional general opiate immunoassays used to screen for hydrocodone and its metabolites, may have given inaccurate results when using the opiate calibrators and controls, per the intended use. As such, they do not have the sensitivities required to meet the proposed SAMHSA guidelines.

Hydrocodone, a semi-synthetic opioid, is an antitussive (cough suppressant) and narcotic analgesic agent for the treatment of moderate to severe pain. Hydrocodone is considered to be one of the most frequently prescribed and misused opiate drugs in the U.S. There are several hundred brand names and generic combinations of hydrocodone products available on the market today.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit


Thermo Fisher Scientific
Kathy Ruzich, 510-979-5157

Record changed: 2016-01-10


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