K962210 · Becton Dickinson Diagnostic Instrument Systems · MDB · Aug 8, 1996 · Microbiology
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
Indications for 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
Submission Summary (Full Text)
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K962210
AUG - 8 1996
# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY: BECTON DICKINSON MICROBIOLOGY SYSTEMS
7 LOVETON CIRCLE
SPARKS, MD 21152
CONTACT: Robert E. James, Director International Regulatory and Quality Development
TELEPHONE: (410) 584-7116
FAX: (410) 584-8121
PREPARED: June 6, 1996
DEVICE NAME: BACTEC® 9050 System
COMMON NAME: Blood Culture Instrument
CLASSIFICATION NAME: Monitor, Microbial Growth
PREDICATE DEVICE: BACTEC® 9240 System
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.
SUMMARY: Table 1 summarizes the similarities and differences between the BACTEC 9050 and the BACTEC 9240/9120.
Nonclinical tests were conducted to determine the substantial equivalence of the BACTEC 9050 to the BACTEC 9240. A total of 485 paired seeded vials were detected in both systems using 23 organisms that were chosen for their clinical relevency and are representative of the organisms for which the various media types are designed to support growth. The current available media was used in the tests along with the recommended minimum and maximum blood volumes. The difference in recovery between the BACTEC 9240 and the BACTEC 9050 systems was 0.2% with a mean time to detection for microorganisms being equal (<0.01 hours). The BACTEC 9050 performed equivalent to the BACTEC 9240.
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Table 1
Comparison of BACTEC 9240/9120 and BACTEC 9050
| | BACTEC 9240/9120 | BACTEC 9050 |
| --- | --- | --- |
| Number of Specimens | 240/120 | 50 |
| Intended Use | Growth and detection of clinical cultures of blood for the presence of microorganisms | Same |
| Sample Type | Blood | Same |
| Culture Analysis | Positivity Algorithms by Media Type | Same |
| Agitation State During Testing | Off | On |
| Detection Optics | Florescence Detector (LED) | Same |
| Incubation Temperature | 35°C ± 1.5°C | Same |
| Protocol Length | 1 to 30 Days | 4 to 7 Days |
| Reagents | Florescent Series Media | Same |
| Specimen Testing Frequency | Every 10 Minutes | Same |
| Power Supplies | Low Voltage DC | Same |
| Display Screen | Displays 6 racks/3 racks | Displays 1 rack (Rotor) |
| Dimensions | 52"W x 38"H x 22.5"D/52"W x 24"H x 22.5"D | 24"W x 28.5"H x 25.5"D |
