SBT — Device To Detect Microbial Colonization Directly From Clinical Specimens. Class II
FDA product code SBT covers "Device To Detect Microbial Colonization Directly From Clinical Specimens.", a Class II medical device regulated under 21 CFR 866.3967. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SBT
- Device Class
- Class II
- Regulation Number
- 866.3967
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230092 | diasorin molecular | Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. a | July 15, 2024 |