510(k) K123274
K123274 is an FDA 510(k) premarket notification submitted by Gen-Probe Prodesse, Inc. for the device "PROGASTRO SSCS ASSAY". The FDA issued a decision of Substantially Equivalent on January 16, 2013. The device falls under product code PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System), a Class II device regulated under 21 CFR 866.3990. Gen-Probe Prodesse, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2013
- Date Received
- October 19, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Device Class
- Class II
- Regulation Number
- 866.3990
- Review Panel
- MI
- Submission Type
A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial 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.