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BD BACTEC Plus Aerobic/F Culture Vials

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K222591

by Becton, Dickinson and Company

Identifiers

510(k) Number
K222591 FDA 510(k)
FDA Product Code
MDB FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 866.2560 FDA 510(k)
Regulation Number
866.2560 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BD BACTEC Plus Aerobic/F Culture Vials are a type of blood culturing system designed for the aerobic culture and recovery of bacteria and yeast from blood samples. These vials contain an enriched soybean-casein digest broth medium with antibiotic-absorbing resin, enabling effective neutralization of antibiotics, anti-cancer drugs, and anti-fungal agents to ensure accurate microbial growth detection.

These single-use, sterile plastic vials are intended for use with BD BACTEC fluorescent series instruments (FX, FX40, 9240, 9050) and are supplied for aerobic culture of 3–10 mL blood samples. The vials are classified under FDA 510(k) clearance (K222591) and comply with the In Vitro Diagnostic Regulation (IVDR). Storage and handling follow standard sterile medical device protocols.

Frequently asked questions

What types of microorganisms can the BD BACTEC Plus Aerobic/F Culture Vials detect from blood samples?

These vials are specifically designed for the aerobic culture and recovery of bacteria and yeast from blood samples. The enriched soybean-casein digest broth medium, combined with antibiotic-absorbing resin, helps neutralize antibiotics, anti-cancer drugs, and anti-fungal agents, ensuring accurate detection of microbial growth.

How much blood volume can each vial accommodate, and are they reusable?

Each BD BACTEC Plus Aerobic/F Culture Vial is intended for a single use and can hold 3–10 mL of blood samples. Since they are single-use, sterile plastic vials, they must not be reused to maintain sterility and accuracy of results.

Which BD BACTEC instruments are compatible with these culture vials?

These vials are designed exclusively for use with BD BACTEC fluorescent series instruments, including the FX, FX40, 9240, and 9050 models. Compatibility ensures proper detection and monitoring of microbial growth in the blood samples.

How should these vials be stored, and what are the key handling considerations?

The vials must be stored and handled according to standard sterile medical device protocols. Since they are single-use and sterile, they should remain unopened until use and protected from contamination. Follow manufacturer guidelines for storage temperature and shelf life to ensure optimal performance.

What regulatory pathways have these vials undergone, and what does that mean for their use?

The BD BACTEC Plus Aerobic/F Culture Vials have undergone FDA 510(k) clearance (K222591) and comply with the In Vitro Diagnostic Regulation (IVDR). This means they have been evaluated for safety and effectiveness by regulatory authorities and are intended for clinical use in microbiology laboratories to aid in diagnosing bloodstream infections.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD BACTEC™ Plus Aerobic/F culture vials - 442023 | BD, BD BACTEC™ Plus Aerobic medium in plastic culture vials, BD BACTEC™ Plus Aerobic/F Culture Vials (K222591) — FDA 510 (k ..., BD (company) - Wikipedia

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (2)

  • FDA 510(k) K222591 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026