FDA Product Code PCI: Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
A Gastrointestinal Bacterial Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Bacterial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Bacterial Nucleic Acid From Individuals Exhibiting Signs And/or Symptoms Of Gastrointestinal Infection Aids In The Diagnosis Of Gastrointestinal Infection When Used In Conjunction With Clinical Evaluation And Other Laboratory Findings.
Leading manufacturers include Becton, Dickinson and Company.
FDA 510(k) Cleared Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System Devices (Product Code PCI)
About Product Code PCI - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code PCI since 2014, with 5 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 PCI have taken an average of 266 days to reach a decision - up from 187 days historically. Manufacturers should account for longer review timelines in current project planning.
PCI devices are reviewed by the Microbiology panel. Browse all Microbiology devices →