Fast PCR Mini Respiratory Panel
FDA 510(k) K252932 · Autonomous Medical Devices Incorporated
Submission
- Device name
- Fast PCR Mini Respiratory Panel
- Applicant
- Autonomous Medical Devices Incorporated
Santa Ana, CA, US - Received
- September 15, 2025
- Decision date
- June 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3981
- Specialty
- Microbiology
A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from…
Other 510(k)s with product code QOF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261837 | FINDER Flu A&B/SARS-CoV-2 TestQOF · Traditional | Baebies, Inc. | 09/11/2026SE |
| K252269 | FINDER Flu A&B/SARS-CoV-2 TestQOF · Dual Track | Baebies, Inc. | 03/30/2026SE |
| K251742 | VELO Respiratory TestQOF · Dual Track | Lex Diagnostics Limited | 02/13/2026SE |
| K251978 | Liaison Nes Flu A/B, RSV & COVID-19QOF · Dual Track | Diasorin Molecular, LLC | 12/23/2025SE |
| K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV…QOF · Traditional | Diasorin Molecular, LLC | 10/30/2025SE |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQOF · Traditional | QIAGEN GmbH | 08/27/2025SE |
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniQOF · Dual Track | Biofire Diagnostics, LLC | 08/14/2025SE |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional | Roche Molecular Systems, Inc. | 07/31/2025SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | Cepheid® | 05/01/2025SE |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | Cepheid® | 05/01/2025SE |
Questions and answers
When was Fast PCR Mini Respiratory Panel cleared by the FDA?
Fast PCR Mini Respiratory Panel (K252932) received a 510(k) decision of Substantially Equivalent on June 12, 2026, 270 days after the submission was received.
What is the product code of K252932?
The FDA product code is QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, a Class II (moderate risk) device regulated under 21 CFR 866.3981.