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Immunoassay for the qualitative detection of barbiturates, benzodiazepine, phencyclidine, and/or their metabolites in human urine.

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The provided document is limited to a 510(k) clearance letter for the AccuSign® DOA3 (BZO/BAR/PCP) device, which is an immunoassay for the qualitative detection of certain drugs in human urine. A 510(k) clearance determines substantial equivalence to a legally marketed predicate device, but it does not typically include detailed information about the acceptance criteria and the specific study data that demonstrates the device meets those criteria.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available within the provided document.

The document primarily states that the FDA reviewed the 510(k) notification and determined the device is substantially equivalent for the stated indications for use (qualitative detection of barbiturates, benzodiazepine, phencyclidine, and/or their metabolites in human urine).

To obtain the detailed study information you're asking for, one would typically need to refer to:

• The original 510(k) submission itself, which contains the test data and performance validation.
• The device's Instructions for Use (IFU) or package insert, which often includes performance characteristics.
• Scientific publications or clinical study reports if the manufacturer chose to publish the validation data.

Without these additional documents, I cannot fulfill your request for the specific study details.

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