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Immunoassay for the qualitative detection of barbiturates and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drug.

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I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA, which confirms that the identified device, AccuSign® BAR, is substantially equivalent to a legally marketed predicate device.

The letter mentions the indications for use of the device: "Immunoassay for the qualitative detection of barbiturates and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drug."

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies or specific effect sizes.
• Information on standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on this document.

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