Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
QMI · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3183
Classification
FDA Product Code
QMI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3183
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.