510(k) K241921
K241921 is an FDA 510(k) premarket notification submitted by Abbott Molecular, Inc. for the device "Alinity m BKV". The FDA issued a decision of Substantially Equivalent on March 24, 2025. The device falls under product code QMI (Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna), a Class II device regulated under 21 CFR 866.3183. Abbott Molecular, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2025
- Date Received
- July 1, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
- Device Class
- Class II
- Regulation Number
- 866.3183
- Review Panel
- MI
- Submission Type
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 analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Test results must not be the sole basis for patient management decisions.