510(k) K214122
K214122 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel". The FDA issued a decision of Substantially Equivalent on July 28, 2022. The device falls under product code PCI (Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System), a Class II device regulated under 21 CFR 866.3990. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2022
- Date Received
- December 30, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
- Device Class
- Class II
- Regulation Number
- 866.3990
- Review Panel
- MI
- Submission Type
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.