Psychemedics Corporation has received 510(K) clearance from the Food and Drug Administration (FDA) for its test for the detection of opiates in human hair. This is the first FDA clearance for a test using human hair for drugs of abuse.
The approved opiate test is a radioimmunoassay for the qualitative and
semi- quantitative detection of morphine in hair for the purpose of
identifying heroin use. The use of heroin is detected through a confirmation
method that identifies the heroin metabolite 6 - monacetylmorphine (6 mam).
This detection of 6 mam eliminates the concerns present in other specimen
testing that opiate positives may be due to poppy seed ingestion.
"With the use of heroin on the rise, and the poppy seed problem inherent
in other tests, it is critical that professionals have access to hair analysis
using our opiate assay," said Ray Kubacki, President of Psychemedics. "We are
pleased to have received FDA's first clearance for hair testing, and intend to
submit additional assays in the near future. We believe that FDA clearance of
our products will encourage the use of Psychemedics' hair analysis in a wider
range of applications."
Psychemedics Corporation is the world's leading laboratory for the
detection of hair for the presence of drugs. Its client list includes over
1,800 corporations (many in the Fortune 500) which use hair testing as part of
their drug-free workplace programs. In addition, several of the country's
largest police departments as well as schools and Federal Reserve Banks rely
on Psychemedics' hair testing.