FDA Product Code QMI: Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna
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.
Leading manufacturers include Abbott Molecular, Inc..
FDA 510(k) Cleared Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna Devices (Product Code QMI)
About Product Code QMI - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QMI since 2020, with 2 receiving FDA clearance (average review time: 147 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QMI have taken an average of 266 days to reach a decision - up from 27 days historically. Manufacturers should account for longer review timelines in current project planning.
QMI devices are reviewed by the Microbiology panel. Browse all Microbiology devices →