(86 days)
BD BACTEC Peds Plus™F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (mainly bacteria and yeast) from pediatric and non-pediatric blood specimens which are generally less than 3 mL in volume.
The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor's fluorescence measurement is detected at regular intervals to determine the change in CO2 present in the system. A positive reading indicates the presumptive presence of viable microorganisms in the vial. BD BACTEC Peds Plus™F culture vial detection is limited to microorganisms that will grow in a particular type of medium.
The document describes the analytical performance criteria and the study conducted for the BD BACTEC™ Peds Plus™/F Culture Vials.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (BD BACTEC Peds Plus/F Plastic Vial vs. Glass Vial) |
|---|---|---|
| Instrument Time to Detection (TTD) | Median TTD difference |
§ 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.