# K252932: Fast PCR Mini Respiratory Panel

- Pathway: 510(k) (Dual Track)
- Applicant: Autonomous Medical Devices Incorporated
- Decided: Jun 12, 2026 after 270 days
- Product code: QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents)
- Device class: 2
- Regulation: 21 CFR 866.3981
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN200031 (2021). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242071: Xpert Xpress CoV-2/Flu/RSV plus, Cepheid (2025) Summary page 5.

## Indications for use
The Fast PCR Mini Respiratory Panel is an automated, multiplexed real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, influenza B and respiratory syncytial virus (RSV) nucleic acids in anterior nasal swab specimens obtained from individuals with signs and symptoms of respiratory tract infections. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B and RSV can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B and RSV infections in humans and is not intended to detect influenza C virus infection. Nucleic acids from the viral organisms identified by this test are generally detectable in anterior nasal swab specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus and aid in the diagnosis if used in conjunction with other clinical and epidemiological information and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Positive results do not rule out co-infection with other organisms. The organism(s) detected by the Fast PCR Mini Respiratory Panel may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B or RSV infections.

Source page: https://510kreport.com/device/K252932
Methodology: https://510kreport.com/methodology