Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
The Nucleic Acid Amplification Test for the Quantitation of BK Virus (BKV) DNA is an in vitro diagnostic device intended to quantitate BKV DNA in human samples as an aid in managing BKV infection in transplant patients, where serial measurements can indicate the need for treatment changes and assess viral response. Results must be interpreted by a qualified healthcare professional in conjunction with clinical signs and relevant laboratory findings, and must not be the sole basis for patient management decisions. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 866.3183 in the Microbiology specialty. It carries product code QMI and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QMI
- Device Class
- FDA class 2
- Regulation Number
- 866.3183
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.