# K143653: Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)

- Pathway: 510(k) (Traditional)
- Applicant: Nanosphere, Inc.
- Decided: Sep 4, 2015 after 255 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to DEN070013 (2008). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143080: FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System, Biofire Diagnostics, LLC (2015). Cleared while this submission was under review Summary page 6.
- K123620: Filmarray Respiratory Panel (RP), Biofire Diagnostics, Inc. (2013) Summary page 6.
- K120267: Filmarray RP Panel, Idaho Technology, Inc. (2012) Summary page 6.
- K110764: Filmarray RP Panel, Idaho Technology, Inc. (2011) Summary page 6.
- K103175: Filmarray Respiratory Panel (RP), Idaho Technology, Inc. (2011) Summary page 6.

## Most influential descendants
- K243753: cobas liat Bordetella panel nucleic acid test (2025), 0 descendants of its own

## Recalls of this device
- Apr 5, 2022 · Class II · Z-1092-2022: Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
- Oct 30, 2020 · Class II · Z-2006-2021: Potential for a false-negative result.
- Oct 13, 2020 · Class II · Z-0476-2021: Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufa
- Oct 13, 2020 · Class II · Z-0477-2021: Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufa
- Dec 10, 2018 · Class II · Z-0054-2021: No results/incorrect results due to failure of the hybridization heater.

## Indications for use
The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. The test is performed on the automated Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and microarray hybridization to detect gene sequences of the following organism types and subtypes: Viruses Bacteria __________________________________________________________________________ Adenovirus Bordetella parapertussis/bronchiseptica Human Metapneumovirus Bordetella holmesii Influenza A Bordetella pertussis Influenza A (Subtype H1) Influenza A (Subtype H3) Influenza B Parainfluenza 1 Parainfluenza 2 Parainfluenza 3 Parainfluenza 4 Respiratory Syncytial Virus A Respiratory Syncytial Virus B Rhinovirus Detecting and identifying specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction with other clinical and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Negative results in the presence of a respiratory illness do not preclude respiratory infection and may be due to infection with pathogens that are not detected by this test or lower respiratory tract infection that is not detected by an NPS specimen. Conversely, positive results do not rule-out infection or co-infection with organisms not detected by RP Flex. The agent(s) detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation may be necessary to establish a final diagnosis of respiratory infection. Clinical evaluation indicates a lower sensitivity specific to RP Flex for the detection of Rhinovirus. If infection with Rhinovirus is suspected, negative samples should be confirmed using an alternative method. Performance characteristics for Influenza A were established when Influenza A/H1 (2009 Pandemic) and A/H3 were the predominant Influenza A viruses in circulation. RP Flex may not detect novel Influenza A strains. 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 used specifically for novel virulent influenza viruses and sent to appropriate health authorities for testing. Viral culture should not be attempted in these cases unless a biosafety level (BSL) 3+ facility is available to receive and culture specimens.

Source page: https://510kreport.com/device/K143653
Methodology: https://510kreport.com/methodology