Intended Use
- The AyoTes Multi Drug 3 Panel Test (AMP/THC/MOP) (Urine) is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of one to three of the following drugs in a variety of combinations in human urine to aid in the diagnosis of drug abuse in individuals suspected of or with symptoms of drug abuse.
These devices are used to obtain visual qualitative results and intended to assist in the determination
of drug compliance.
- The test is an in vitro diagnosis medical device intended for professional use in laboratory environment. It is not intended for near-patient or self-testing. The test procedure is not automated.
- 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) or Liquid Chromatography/ Mass Spectrometry (LC/MS) are the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.