(392 days)
BACTEC® PLUS 26 Culture Vials
Not Found
No
The device description and performance studies focus solely on the chemical composition of the growth medium and its ability to recover fungi, with no mention of AI or ML for analysis or interpretation.
No.
The device is a growth medium used for culturing and recovering yeasts and fungi from blood samples for diagnostic purposes, not for treating a condition.
Yes.
The device is intended for the qualitative culture and recovery of yeasts and fungi from blood, which is a diagnostic purpose to detect the presence of microorganisms.
No
The device description clearly states it is a "growth medium" and is used with "BACTEC non-radiometric (NR) series instruments," indicating it is a physical product (medium) and relies on hardware (instruments).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Qualitative culture and recovery of yeasts and fungi from blood." This clearly indicates the device is used to examine specimens taken from the human body (blood) to provide information for diagnostic purposes (detecting the presence of yeasts and fungi).
- Device Description: The description details a "growth medium" used with instruments for "monitoring of clinical blood specimens for the presence of yeasts and fungi." This further supports its use in a laboratory setting for diagnostic testing.
- Performance Studies: The inclusion of clinical performance studies comparing the device to other methods for detecting fungi in blood reinforces its role in diagnostic evaluation.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Qualitative culture and recovery of yeasts and fungi from blood
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A multi-center clinical study comparing BACTEC® Fungal Medium, BACTEC® PLUS 26 blood culture medium, and the ISOLATOR™ Microbial Tubes/ISOSTAT® Microbial System (IS System) was conducted at four university-affiliated hospitals. There were a total of 4886 adequately filled paired vials in the comparison of BACTEC® Fungal Medium to BACTEC® PLUS 26 blood culture medium, and 4907 adequately filled paired vials and tubes in the comparison of BACTEC® Fungal Medium to the IS System. Of the 229 clinically significant isolates recovered in the comparison of BACTEC® Fungal Medium to BACTEC® PLUS 26 blood culture medium, 161 were bacteria and 68 were fungi. Of the 68 fungi, 31 isolates (45.6%) were recovered in both media, 11 (16.2%) were recovered in BACTEC® PLUS 26 blood culture medium only, and 26 (38.2%) were 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.
0
510(k) SUMMARY
NOV 21 1996
| SUBMITTED BY: | BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
7 LOVETON CIRCLE
SPARKS, MD 21152 |
|-------------------|----------------------------------------------------------------------------------------|
| CONTACT: | Dennis Mertz, Manager Regulatory Affairs |
| TELEPHONE: | (410) 316-4099 |
| FAX: | (410) 316-4499 |
| PREPARED: | October 25, 1995 |
| DEVICE NAME: | BACTEC® Fungal Medium |
| PREDICATE DEVICE: | BACTEC® PLUS 26 Culture Vials |
| INTENDED USE: | Qualitative culture and recovery of yeasts and fungi from blood |
DEVICE DESCRIPTION:
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.
SUBSTANTIAL EQUIVALENCE:
Table 1 summarizes the similarities and differences between BACTEC® Fungal Medium and BACTEC® PLUS 26 Culture Vials.
1
| to BACTEC® PLUS 26 Culture Vials | ||
|---|---|---|
| BACTEC® Fungal Medium | BACTEC® PLUS 26 | |
| Intended use | Qualitative culture and recovery of yeasts and fungi | Qualitative culture and recovery of aerobic |
| microorganisms (mainly bacteria and | ||
| fungi) | ||
| Sample type | Blood | Blood |
| Sample volume | 4 - 10 mL | 5 - 10 mL |
| Blood to broth ratio | 1 to 2.5 | 1 to 2.5 |
| Growth medium | Enriched brain heart infusion broth with CO₂ | Enriched soybean-casein digest broth with CO₂ |
| Lysing Agent | Saponin (0.24% w/v) | None |
| Reactive ingredient | ||
| concentrations | ||
| • Processed water | 25 mL | 25 mL |
| • Brain heart | ||
| infusion broth | 1.0% w/v | 2.75% w/v |
| • Soybean-casein | ||
| digest broth | 0.035% w/v | 0.25% w/v |
| • Yeast extract | 0.035% w/v | 0.06% w/v |
| • Dextrose | 0.1% w/v | 0.084% w/v |
| • Sucrose | 0.6% w/v | |
| • m-Inositol | 0.05% w/v | 0.0005% w/v |
| • Hemin | --- | 0.00005% w/v |
| • Menadione | --- | --- |
| • Ferric | ||
| ammonium | ||
| citrate | 0.0001% w/v | 0.001% w/v |
| • Pyridoxal HCl | --- | --- |
| • Saponin | 0.24% w/v | --- |
| • Anti-foaming | ||
| agent | 0.01% w/v | --- |
| • SPS | 0.05% w/v | 0.05% w/v |
| • Chloramphenicol | 0.005% w/v | --- |
| • Tobramycin | 0.001% w/v | --- |
| • Nonionic | ||
| adsorbing resin | --- | 16.0% w/v |
| • Cationic | ||
| exchange resin | --- | 1.0% w/v |
| Resins | None | Yes (see above) |
| Instrument | BACTEC® NR instruments | BACTEC® NR instruments |
| Growth detection | Infrared spectrophotometric | |
| measurement of CO₂ produced by | ||
| microorganisms metabolizing | ||
| culture medium nutrients | Infrared spectrophotometric | |
| measurement of CO₂ produced by | ||
| microorganisms metabolizing | ||
| culture medium nutrients | ||
| Incubation | ||
| temperature | 35°C ± 1.5°C | 35°C ± 1.5°C |
| Agitation | Orbital agitation for the first 24 | |
| hours recommended | Orbital agitation for the first 24 | |
| hours recommended | ||
| Vial glass | Type III, soda lime | Type III, soda lime |
| Closure | Rubber | Rubber |
Table 1. Substantial Equivalence of BACTEC® Fungal Medium
- Substantial Equivalence or use of Active Viele C® PI US 26 Culture Vials D
2
CLINICAL PERFORMANCE:
A multi-center clinical study comparing BACTEC® Fungal Medium, BACTEC® PLUS 26 blood culture medium, and the ISOLATOR™ Microbial Tubes/ISOSTAT® Microbial System (IS System) was conducted at four university-affiliated hospitals. There were a total of 4886 adequately filled paired vials in the comparison of BACTEC® Fungal Medium to BACTEC® PLUS 26 blood culture medium, and 4907 adequately filled paired vials and tubes in the comparison of BACTEC® Fungal Medium to the IS System. Of the 229 clinically significant isolates recovered in the comparison of BACTEC® Fungal Medium to BACTEC® PLUS 26 blood culture medium, 161 were bacteria and 68 were fungi. Of the 68 fungi, 31 isolates (45.6%) were recovered in both media, 11 (16.2%) were recovered in BACTEC® PLUS 26 blood culture medium only, and 26 (38.2%) were recovered in BACTEC® Fungal Medium only. Recovery of all fungi combined and of Torulopsis glabrata was statistically significantly better (p