510(k) DEN230092
DEN230092 is an FDA 510(k) premarket notification submitted by Diasorin Molecular, LLC for the device "Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)". The FDA issued a decision of De Novo Granted on July 15, 2024. The device falls under product code SBT (Device To Detect Microbial Colonization Directly From Clinical Specimens.), a Class II device regulated under 21 CFR 866.3967. Diasorin Molecular, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 15, 2024
- Date Received
- December 28, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device To Detect Microbial Colonization Directly From Clinical Specimens.
- Device Class
- Class II
- Regulation Number
- 866.3967
- Review Panel
- MI
- Submission Type
A device to detect microbial colonization directly from clinical specimens is a qualitative in vitro diagnostic device intended for the detection and identification of microbial-associated targets from patients who are suspected of being colonized with a microbial pathogen and may present a risk of transmission to other patients and health care workers. This device is intended to aid in the detection of microbial colonizers for the prevention and control of infection in healthcare settings when used in conjunction with clinical and laboratory findings.