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 and Micronics, Inc..
5
Total
5
Cleared
203d
Avg days
2014
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg
266d
recently vs 187d historically
FDA 510(k) Cleared Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System Devices (Product Code PCI)
5 devices
Cleared
Oct 31, 2025
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
Becton, Dickinson and Company
Microbiology
266d
Cleared
Jul 28, 2022
BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
Becton, Dickinson and Company
Microbiology
210d
Cleared
Jun 01, 2018
PanNAT STEC Test
Micronics, Inc.
Microbiology
221d
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 510(k) Review Time - PCI Product Code
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 →