# K222559: BD BACTEC™ Myco/F Lytic Culture Vials

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Mar 24, 2023 after 212 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970512 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970333: Bactec Myco/F Lytic Culture Vials, Becton Dickinson Microbiology Systems (1998) Summary page 3.
- K970512: Bactec Myco/F Lytic Culture Vials, Becton Dickinson Microbiology Systems (1998) Summary page 3.

## Indications for use
BD BACTEC Myco/F Lytic culture medium when used with the BD BACTEC fluorescent series instruments is a nonselective culture medium to be used as an adjunct to aerobic blood culture media for the qualitative culture and recovery of mycobacteria, yeast and fungi from blood. This medium may also be used for the culture of sterile body fluids when yeast or fungi are suspected. The device aids in the diagnosis of disease caused by pathogenic microorganisms and is automated on the BD BACTEC fluorescent series instruments.

Source page: https://510kreport.com/device/K222559
Methodology: https://510kreport.com/methodology