(41 days)
The Phencyclidine Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 25 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Phencyclidine Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GS/MS) is 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 used.
The Roche ONLINE DAT Phencyclidine Plus reagent is an in vitro diagnostic test for the qualitative and semi-quantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 25 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
The ONLINE DAT Phencyclidine Plus assay is based on the kinetic interaction of microparticles in a solution (KIMS technology). Assay measurement is based on measurable changes in light transmission related to the interaction of microparticles in a solution and the sample drug of interest, if present. Phencyclidine drug derivative is conjugated to microparticles. A monoclonal antibody (mouse) is solubilized in buffer. In the absence of sample drug, free antibody binds to drug-microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.
When a urine sample contains the drug in question, this drug competes with the particle-bound drug derivative for free antibody. Antibody bound to the particle bound drug is not available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug lowers the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
The provided text is a 510(k) summary for the Roche ONLINE DAT Phencyclidine Plus device, which is an in vitro diagnostic test. The document specifies the device's intended use and compares it to a predicate device, but it does not contain the specific information required to address the user's request.
Specifically, the document does not provide any acceptance criteria or details of a study (test set, ground truth, sample sizes, expert qualifications, adjudication methods, or comparative effectiveness studies) that proves the device meets acceptance criteria. It primarily focuses on regulatory approval and device description.
Therefore, I cannot generate the requested information based on the provided text.
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