(59 days)
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.
BACTEC® 9050 System is a non-radiometric automated blood culturing system. It has a capacity of 50 specimens, uses Positivity Algorithms by Media Type for culture analysis, has agitation on during testing, uses a Florescence Detector (LED) for detection optics, incubates at 35°C ± 1.5°C, has a protocol length of 4 to 7 Days, uses Florescent Series Media, tests specimens every 10 Minutes, uses Low Voltage DC power supplies, and displays 1 rack (Rotor). Its dimensions are 24"W x 28.5"H x 25.5"D.
Here's an analysis of the provided text, focusing on the acceptance criteria and study details:
Acceptance Criteria and Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device rather than defining specific numerical acceptance criteria for a novel performance threshold. The core acceptance criterion appears to be that the BACTEC 9050 performs "equivalent" to the BACTEC 9240.
| Acceptance Criteria | Reported Device Performance (BACTEC 9050 vs. BACTEC 9240) |
|---|---|
| Recovery rate of microorganisms for clinically relevant organisms using available media and recommended blood volumes. | Difference in recovery: 0.2% |
| Mean time to detection of microorganisms. | Mean time to detection: Equal ( |
§ 866.2560 Microbial growth monitor.
(a)
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.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.