Alinity m Resp-4-Plex
FDA 510(k) K241573 · Abbott Molecular, Inc.
Submission
- Device name
- Alinity m Resp-4-Plex
- Applicant
- Abbott Molecular, Inc.
Des Plaines, IL, US - Received
- June 3, 2024
- Decision date
- February 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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…
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| K252932 | Fast PCR Mini Respiratory PanelQOF · Dual Track | Autonomous Medical Devices Incorporated | 06/12/2026SE |
| 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 |
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| K252102 | Alinity m HCVMZP · Traditional | 09/25/2025SE |
| K243489 | Alinity m EBV (09N43-095)QLX · Traditional | 07/28/2025SE |
| K243485 | Alinity m CMVPAB · Traditional | 07/01/2025SE |
| K241921 | Alinity m BKVQMI · Traditional | 03/24/2025SE |
| K243410 | simpli-COLLECT STI TestQYA · Traditional | 01/30/2025SE |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)QQX · Traditional | 12/06/2024SE |
| K233349 | Alinity m HSV 1 & 2 / VZVPGI · Traditional | 05/03/2024SE |
| K222379 | Alinity m STI AssayQEP · Traditional | 03/03/2023SE |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085)…QLX · Traditional | 07/15/2022SE |
| K202977 | Alinity m STI AssayQEP · Traditional | 04/29/2022SE |
Questions and answers
When was Alinity m Resp-4-Plex cleared by the FDA?
Alinity m Resp-4-Plex (K241573) received a 510(k) decision of Substantially Equivalent on February 14, 2025, 256 days after the submission was received.
What is the product code of K241573?
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.