DEN230092 is an FDA 510(k) submission for the Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390). This device is classified as a Device To Detect Microbial Colonization Directly From Clinical Specimens. (Class II - Special Controls, product code SBT).
Submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Not Cleared (DENG) decision on July 15, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3967. 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..
| 510(k) Number | DEN230092 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 28, 2023 |
| Decision Date | July 15, 2024 |
| Days to Decision | 200 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | SBT - Device To Detect Microbial Colonization Directly From Clinical Specimens. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3967 |
| Definition | 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. |