PCI

5 FDA 510(k) clearances · Product code

FDA profile

Official device name

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3990

Medical specialty

Microbiology

FDA definition

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.

Adverse events (MAUDE)

2023: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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