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The DiaSorin Molecular Simplexa™ Flu A/B & RSV Direct Gen II assay is intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection and differentiation of influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A. influenza B. and RSV viral infections in humans.

Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for influenza A were established with clinical specimens collected during the 2010/2011 influenza season when 2009 H1N1 influenza and H3N2 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to the state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The DiaSorin Molecular Simplexa™ Flu A/B & RSV Positive Control Pack is intended to be used as a control with the Simplexa™ Flu A/B & RSV Direct kit and the Simplexa™ Flu A/B & RSV Direct Gen II kit for use on the LIAISON® MDX instrument. This control is not intended for use with other assays or systems.

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The provided document is a 510(k) clearance letter from the FDA for the DiaSorin Molecular Simplexa™ Flu A/B & RSV Direct Gen II assay. It primarily focuses on the device's regulatory clearance and indications for use, not on the detailed study results and acceptance criteria for performance evaluation.

Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria and performance study specifics from this document. The document states that the device is "substantially equivalent" to a legally marketed predicate device, implying that its performance was assessed, but the actual data and criteria are not included here.

To provide the answers you're looking for, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or the actual clinical study report that was submitted to the FDA for review.

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