FDA Product Code QLX: Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
A Quantitative Viral Nucleic Acid Test For Transplant Patient Management Is Identified As A Device Intended For Prescription Use In The Detection Of Viral Pathogens By Measurement Of Viral Deoxyribonucleic Acid (dna) Or Ribonucleic Acid (rna) Using Specified Specimen Processing, Amplification, And Detection Instrumentation. The Test Is Intended For Use As An Aid In The Management Of Transplant Patients With Active Viral Infection Or At Risk For Developing Viral Infections. The Test Results Are Intended To Be Interpreted By Qualified Healthcare Professionals In Conjunction With Other Relevant Clinical And Laboratory Findings.
Leading manufacturers include Abbott Molecular, Inc. and Roche Molecular Systems, Inc..
FDA 510(k) Cleared Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna Devices (Product Code QLX)
About Product Code QLX - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QLX since 2020, with 3 receiving FDA clearance (average review time: 203 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QLX have taken an average of 258 days to reach a decision - up from 185 days historically. Manufacturers should account for longer review timelines in current project planning.
QLX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →