(392 days)
Qualitative culture and recovery of yeasts and fungi from blood
BACTEC Fungal Medium is a growth medium providing an aerobic environment for the detection of yeast and fungi. It has been designed for blood volumes of four to 10 mL, and is used specifically with BACTEC non-radiometric (NR) series instruments in the monitoring of clinical blood specimens for the presence of yeasts and fungi. BACTEC Fungal medium has a higher weight/volume concentration of dextrose and sucrose then the predicate device to enhance the recovery and CO2 production of yeast. Saponin was added to the BACTEC Fungal Medium as a lysing agent, and ferric ammonium citrate was added as a source of iron to stimulate recovery of fungi other than yeast. Resin was removed from this medium. Principles for detection of CO2 produced by microorganisms metabolizing blood culture medium nutrients are identical to the predicate device.
Here's a breakdown of the acceptance criteria and study details for the BACTEC® Fungal Medium, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The acceptance criteria are implicitly derived from the comparative study against predicate devices (BACTEC® PLUS 26 Culture Vials and ISOLATOR™ Microbial Tubes/ISOSTAT® Microbial System). The goal is to demonstrate that the BACTEC® Fungal Medium performs "as good or better than" or "equivalent to" these predicate devices for the recovery of yeasts and fungi from blood, particularly in terms of recovery rates and speed of detection.
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance (BACTEC® Fungal Medium) |
|---|---|---|
| Recovery of Fungi | Vs. BACTEC® PLUS 26: Statistically significantly better recovery of all fungi combined and of Torulopsis glabrata. |
Vs. IS System: Equivalent recovery of fungi, with the exception of Histoplasma capsulatum. (i.e., performance should not be significantly worse for most fungi). | Vs. BACTEC® PLUS 26:
- 68 fungi isolates total.
- 31 (45.6%) recovered in both media.
- 11 (16.2%) recovered in BACTEC® PLUS 26 only.
- 26 (38.2%) recovered in BACTEC® Fungal Medium only.
- **Recovery of all fungi combined and of Torulopsis glabrata was statistically 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.