510(k) · Cleared
ClearedFast PCR Mini Respiratory Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Autonomous Medical Devices Incorporated · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Cleared on Jun 12, 2026 as substantially equivalent to K242071 (Cepheid, 2025) after a 270-day review. Its family tree reaches back 3 generations to 2021.
- Decided
- Jun 12, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- QOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN200031 (2021). No later device cites it as a predicate yet.
- Root · 3 generations backDEN200031 BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC · 2021
- 2 generations backK231481 Xpert Xpress CoV-2/Flu/RSV plusCepheid® · 2023
- 1 generation backK242071 Xpert Xpress CoV-2/Flu/RSV plusCepheid · 2025
- This deviceK252932 Fast PCR Mini Respiratory PanelAutonomous Medical Devices Incorporated · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021 | — |
| −2 | K231481 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid® | 2023 | — |
| −1 | K242071 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid | 2025 | — |
| 0 (this device) | K252932 | Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QOF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QOF device
- #1 K241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV Assayscore 17.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K242071 | Xpert Xpress CoV-2/Flu/RSV plusSummary page 5…SARS-CoV-2 and Other Microbial Agents Predicate Device: Xpert Xpress CoV-2/Flu/RSV plus, performed on the GeneXpert Xpress System (K242071) Autonomous Medical Devices Incorporated Page 1 of 24… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K242071.
How does its category compare?
All QOF devicesQOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QOF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QOF
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QOF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QOF
10in 2025
MAUDE reports naming product code QOF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 7 | 238 | 1 | 6 |
| 2024 | 9 | 147 | 1 | 30 |
| 2025 | 13 | 178 | 1 | 10 |
| 2026 | 8 | 128 | 2 | — |
What is it indicated for?
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…
Read the full statement (244 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252932 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252932: Fast PCR Mini Respiratory Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252932
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026