Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
FDA 510(k) K241580 · Abbott Molecular
Submission
- Device name
- Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
- Applicant
- Abbott Molecular
Des Plaines, IL, US - Received
- June 3, 2024
- Decision date
- December 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QQX – Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
- 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 SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The…
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More from Biofire Defense, LLC
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K241573 | Alinity m Resp-4-PlexQOF · Traditional | 02/14/2025SE |
| K243410 | simpli-COLLECT STI TestQYA · Traditional | 01/30/2025SE |
| 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 SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) cleared by the FDA?
Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) (K241580) received a 510(k) decision of Substantially Equivalent on December 6, 2024, 186 days after the submission was received.
What is the product code of K241580?
The FDA product code is QQX – Respiratory Specimen Nucleic Acid Sars-Cov-2 Test, a Class II (moderate risk) device regulated under 21 CFR 866.3981.