BACTEC 9050 SYSTEM
Device Facts
| Record ID | K962210 |
|---|---|
| Device Name | BACTEC 9050 SYSTEM |
| Applicant | Becton Dickinson Diagnostic Instrument Systems |
| Product Code | MDB · Microbiology |
| Decision Date | Aug 8, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2560 |
| Device Class | Class 1 |
Intended Use
A non-radiometric automated blood culturing system which is designed for the monitoring and detection of clinical cultures of blood for the presence of microorganisms.
Device Story
Automated blood culture instrument; monitors blood samples for microbial growth. Uses fluorescent detection optics (LED) to analyze culture vials. System incubates samples at 35°C ± 1.5°C; utilizes agitation during testing. Operates in clinical microbiology laboratories; managed by laboratory technicians. System performs automated analysis of culture vials every 10 minutes. Output provides detection of microbial presence; alerts clinicians to positive cultures. Facilitates rapid identification of bloodstream infections; supports clinical decision-making regarding antimicrobial therapy.
Clinical Evidence
Bench testing only. Comparison of 485 paired seeded vials using 23 clinically relevant organisms across various media types. Mean time to detection difference <0.01 hours; recovery difference 0.2% between BACTEC 9050 and BACTEC 9240.
Technological Characteristics
Automated blood culture system; fluorescent detection optics (LED); incubation at 35°C ± 1.5°C; agitation enabled; 50-specimen capacity (rotor); low voltage DC power; dimensions 24"W x 28.5"H x 25.5"D; utilizes fluorescent series media.
Indications for Use
Indicated for clinical blood culture monitoring to detect presence of microorganisms in patient blood samples.
Regulatory Classification
Identification
A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
Predicate Devices
- BACTEC® 9240 System
Reference Devices
- BACTEC® 9120
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