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NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatic patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection.

Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 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 authorties, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

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The provided document is an FDA 510(k) clearance letter for the NxTAG Respiratory Pathogen Panel, a diagnostic device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way described in your prompt (e.g., performance against ground truth established by experts, MRMC studies, or standalone algorithm performance). This document is primarily an administrative letter confirming substantial equivalence to a predicate device and outlining regulatory information.

The information you are requesting typically comes from detailed study reports submitted as part of the 510(k) application, which are not included in this clearance letter. The letter briefly mentions "Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons," but it does not provide the specific performance metrics, study design, or ground truth details.

Therefore, I cannot fulfill your request using only the information provided in the given document. The document confirms the device's clearance and its intended use, but it does not delve into the specifics of the validation study's acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

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NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatic patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection.

Performance characteristics for influenza A were established using the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 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 infections for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

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The provided text is a 510(k) summary for the NxTAG® Respiratory Pathogen Panel, MAGPIX® Instrument, and SYNCT Software. It describes the device's indications for use and general regulatory information. However, it does not contain the detailed study information, acceptance criteria, or performance data that would be necessary to answer the questions about how the device meets acceptance criteria.

The document is a clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance rather than detailed clinical study results.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) submission, the clinical study report, or similar performance evaluation documentation.

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