FDA Product Code QYA: System For Detection Of Nucleic Acid From Non-viral Microorganism(s) Causing Stis Using Specimens Collected At Home
This Device Is An In Vitro Diagnostic System Intended For Self-collecting Specimens In Home Settings Or Similar Environments And Testing In A Clinical Laboratory For Detection Of Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Sexually Transmitted Infections. The Device Is Intended For Prescription Use Or Over-the-counter Use.
Leading manufacturers include Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) and Abbott Molecular.
FDA 510(k) Cleared System For Detection Of Nucleic Acid From Non-viral Microorganism(s) Causing Stis Using Specimens Collected At Home Devices (Product Code QYA)
About Product Code QYA - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QYA since 2023, with 1 receiving FDA clearance (average review time: 592 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 QYA have taken an average of 90 days to reach a decision - down from 1094 days historically, suggesting improved FDA processing for this classification.
QYA devices are reviewed by the Microbiology panel. Browse all Microbiology devices →