Alinity m BKV
FDA 510(k) K241921 · Abbott Molecular, Inc.
Submission
- Device name
- Alinity m BKV
- Applicant
- Abbott Molecular, Inc.
Des Plaines, IL, US - Received
- July 1, 2024
- Decision date
- March 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QMI – Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3183
- Specialty
- Microbiology
An in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human samples intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. Test results are intended to be read and…
Other 510(k)s with product code QMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitQMI · Traditional | Roche Molecular Systems, Inc. | 09/02/2020SE |
More from Roche Molecular Systems, Inc.
| 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 |
| K241573 | Alinity m Resp-4-PlexQOF · Traditional | 02/14/2025SE |
| 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 BKV cleared by the FDA?
Alinity m BKV (K241921) received a 510(k) decision of Substantially Equivalent on March 24, 2025, 266 days after the submission was received.
What is the product code of K241921?
The FDA product code is QMI – Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna, a Class II (moderate risk) device regulated under 21 CFR 866.3183.