Hair Testing Company Wins FDA 510(k) Clearance

Omega Laboratories, Inc. announced it has become the first laboratory to receive clearance for its Extended Opiates Test, which detects the use of Oxycodone and Hydrocodone. The clearance included the test for codeine, morphine, and heroin.

Omega Laboratories, Inc. announced it has become the first laboratory to receive 510(k) clearance from the Food and Drug Administration for its Extended Opiates Test, which detects the use of Oxycodone and Hydrocodone through human hair analysis. The clearance included the test for codeine, morphine, and heroin.

The company said increasing concern about prescription drug abuse has made the ability to test for Oxycodone (e.g., OxyContin® and Percocet®)* and Hydrocodone (e.g., Vicodin® and Lortab®) increasingly important to employers, and the U.S. Department of Health and Human Service's Drug Testing Advisory Board sees this type of clearance as a key component in the future adoption of hair testing to Federal Workplace Drug Testing Programs.

"At Omega, we are focused on providing the highest-quality and most reliable testing procedure available," said Dr. John Vitullo, CEO of Omega Laboratories. "This clearance means that we offer our clients an unsurpassed level of expertise and proficiency in our hair testing for drugs of abuse process. This clearance is one more way Omega maintains its position as the industry leader in testing expertise and customer service."

Omega's news release said its 510(k) submission contained more than 13,000 pages "and included extensive studies involving precision, agreement, stability, recovery, effects of contamination, and the effects of different hair cosmetic treatments including multiple coloring products, straighteners/relaxers, and shampoos marketed to evade a drug test. Hair color, curvature and ethnic origin of the samples were also analyzed to ensure that a diverse population was represented in the studies. A shipping study was performed showing there were no effects to the hair samples from extreme temperature and humidity changes, unlike the problems that have plagued the transport of urine samples," it stated.

"In addition to being the only hair testing laboratory with clearance for an Oxycodone and Hydrocodone test, Omega was the first hair testing laboratory in the United States accredited to the ISO/IEC 17025 standard," said Vitullo. "Accrediting agencies have referred to ISO/IEC 17025 as the gold standard of laboratory accreditation, and we feel strongly that it is the most comprehensive quality process available to our industry."

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    November December 2020

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