(88 days)
BacT/ALERT® FA Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic microorganisms (bacteria and yeast) from blood and other normally sterile body fluids.
BacT/ALERT® PF Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic microorganisms (bacteria and yeast) from blood.
The BacT/ALERT® Microbial Detection Systems utilizes a colorimetric sensor and reflected light to monitor the presence and production of carbon dioxide (CO2) dissolved in the culture medium. If microorganisms are present in the test sample, carbon dioxide is produced as the microorganisms metabolize the substrates in the culture medium. When growth of the microorganisms produces CO2 the color of the gas-permeable sensor installed in the bottom of each culture bottle changes from blue-green to yellow. The lighter color results in an increase of reflectance units monitored by the system. Bottle reflectance is monitored and recorded by the instrument every 10 minutes.
BacT/ALERT® Microbial Detection Systems are used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremia/fungemia. The BacT/ALERT® Systems and culture bottles provide both a microbial detection system and a culture medium with suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and other normally sterile body fluid infections. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorqanisms that will grow in the BacT/ALERT® FA Plus or PF Plus Culture Bottle (The BacT/ALERT® PF Plus Culture Bottle provides for detection of microorganisms when a small volume of blood is available.).
The provided text describes the performance characteristics of the BacT/ALERT® FA Plus and BacT/ALERT® PF Plus culture bottles, which are microbial detection systems. The study aims to demonstrate the equivalency of a modified formulation of these devices to their predicate devices.
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance and Notes |
|---|---|---|
| Growth Performance | Recovery Rate: Equivalent recovery rates based on Newcombe's Hybrid Score. | |
| Time to Detection (TTD): Equivalent TTD based on the mean percent difference in TTD. | Recovery Rate: Met criteria for equivalency for all 39 microorganisms in both presence and absence of blood. | |
| TTD (with blood): Met criteria for 38 of 39 microorganisms. A delay was observed for Haemophilus parainfluenzae, though both adjusted and predicate had |
§ 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.