(80 days)
The evidence® Phencyclidine test has been designed for use only on the evidence® analyser for qualitative detection of phencyclidine in urine, using a cut-off concentration of 25 ng/ml. Qualitative results obtained can be utilised in the diagnosis and treatment of phencyclidine use or overdose.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS) is the preferred method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Phencyclidine Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, opiates and phencyclidine. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system.
The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies for a medical device.
The document is a regulatory approval letter, stating that the "evidence® Phencyclidine Assay" and "evidence® Drugs of Abuse Calibrators" are substantially equivalent to legally marketed predicate devices. It discusses the intended use of the devices and regulatory compliance, but not the technical details of studies proving performance against acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
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