# K254139: BioCode® Respiratory Pathogen Panel (RPP)

- Pathway: 510(k) (Traditional)
- Applicant: Applied BioCode, Inc.
- Decided: May 1, 2026 after 130 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to DEN070013 (2008). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192485: BioCode Respiratory Pathogen Panel (RPP), Applied BioCode, Inc. (2019) Summary page 6.

## Indications for use
The BioCode Respiratory Pathogen Panel (RPP) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BioCode MDx-3000 Instrument. The BioCode RPP is capable of the simultaneous detection and identification of nucleic acids from multiple viruses and bacteria extracted from nasopharyngeal swab (NPS) samples obtained from individuals with signs and/or symptoms of respiratory tract infection. The following pathogens and subtypes are identified using the BioCode RPP: • Adenovirus • Coronavirus (229E, OC43, HKU1, and NL63) • Human Metapneumovirus A/B • Influenza A, including subtypes H1, H1 2009 Pandemic, and H3 • Influenza B • Parainfluenza 1 • Parainfluenza 2 • Parainfluenza 3 • Parainfluenza 4 • Respiratory Syncytial Virus A/B • Rhinovirus/Enterovirus • Bordetella pertussis • Chlamydia pneumoniae • Mycoplasma pneumoniae The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and/or symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. 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 that are not detected by this test, or lower respiratory tract infection that may not be detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the BioCode RPP may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with a possible respiratory tract infection. Due to the genetic similarity between Human Rhinovirus and Enterovirus, the BioCode RPP cannot differentiate them. A positive BioCode RPP Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. The BioCode RPP detects Human Rhinovirus/Enterovirus with reduced sensitivity. If a more accurate HRV/EV result is required, it is recommended that specimens found to be negative for Human Rhinovirus/Enterovirus after examination using BioCode RPP be confirmed by an alternate method (e.g., FDA cleared molecular tests). Performance characteristics for Influenza A were established when Influenza A H1 2009 Pandemic and A H3 were the predominant Influenza A viruses in circulation. Performance of detecting Influenza A may vary if other Influenza A strains are circulating, or a novel Influenza A virus emerges. 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 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.

Source page: https://510kreport.com/device/K254139
Methodology: https://510kreport.com/methodology