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The Cozart EIA Opiates Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for Opiates in human oral fluid at a cutoff concentration of 10ng/ml. This is equal to 30ng/mL in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample. This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.

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The provided document is a 510(k) premarket notification letter from the FDA to Cozart Bioscience Ltd. regarding the Cozart EIA Opiate Oral Fluid Kit. This letter confirms that the device has been found substantially equivalent to legally marketed predicate devices.

However, this document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria. It primarily focuses on the regulatory approval process and the device's indications for use.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, and study methodologies from this specific document. The letter itself does not detail the technical studies or their results, but rather refers to them implicitly by stating that the device has met the requirements for substantial equivalence.

To answer your request, I would need access to the actual 510(k) submission and the studies referenced within it.

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