(105 days)
A qualitative procedure for the culture and recovery of aerobic microorganisms (mainly bacteria and fungi) from pediatric and other blood specimens which are generally less than 3 mL in volume.
BACTEC PEDS PLUS medium is a bacterial growth medium providing an aerobic environment for the detection of bacteria and fungi. It has been designed for the recovery of microorganisms from pediatric and other blood specimens which are generally less than 3 mL in volume and is used specifically with the BACTEC NR ( non-radiometric )blood culture series instruments. Each glass vial of medium contains 20 mL of enriched Soybean-Casein Digest Broth with resins and CO2. If microorganisms are present in the test sample inoculated into the BACTEC vial, CO2 will be produced and liberated into the atmosphere when the organisms metabolize the substrates present in the vial. The instrument analyzes the vial head space gas for CO2 and, If a threshold level is exceeded, indicates that the vial is positive, i.e., that the test sample contains viable organisms.
Here's a breakdown of the acceptance criteria and study details for the BACTEC® PEDS PLUS™ Culture Vials, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (BACTEC PEDS PLUS) |
|---|---|
| Detects clinically significant organisms | Overall Recovery: 256 organisms detected (181 from both + 75 from PEDS PLUS only) out of 289 total clinically significant organisms (88.6%). |
| Better or equivalent recovery of organisms compared to predicate device (BACTEC NR6A) | Significantly better (p |
§ 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.