System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
The System, Microbial Growth Monitor of Normally Sterile Body Fluid Culture is a qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid samples incubated in a liquid culture medium, used to detect infection in sterile body fluids such as cerebrospinal or peritoneal fluid. It is classified as a Class 1 device under regulation 866.2560, subject to general controls only, requiring 510(k) premarket notification. The product code is QBQ, and it falls within the Microbiology (MI) medical specialty. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- QBQ
- Device Class
- FDA class 1
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K172412 | BacterioScan 216Dx System | May 01, 2018 | Substantially Equivalent | Bacterioscan, Inc. |