510(k) K202215
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2020
- Date Received
- August 6, 2020
- 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.