FDA Product Code PMN: Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use.
Leading manufacturers include Maine Molecular Quality Controls, Inc., Streck and Streck, LLC.
FDA 510(k) Cleared Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays Devices (Product Code PMN)
About Product Code PMN - Regulatory Context
510(k) Submission Activity
30 total 510(k) submissions under product code PMN since 2016, with 29 receiving FDA clearance (average review time: 139 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA Review Time
Recent submissions under PMN have taken an average of 73 days to reach a decision - down from 152 days historically, suggesting improved FDA processing for this classification.
PMN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →