# K970333: Bactec Myco/F Lytic Culture Vials

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Jan 28, 1998 after 365 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BACTEC 13A Mycobacteria Culture Medium: named in the summary without a submission number
- (no number) BACTEC NR Fungal Culture Medium: named in the summary without a submission number
- (no number) ISOLATOR™ System: named in the summary without a submission number

## Most influential descendants
- K222559: BD BACTEC™ Myco/F Lytic Culture Vials (2023), 0 descendants of its own

## Indications for use
The BACTEC® MYCO/F Lytic culture vials when used with the 9000 Blood Culture series of instrumentation are intended as an adjunct to routine blood culture for patients suspected of having mycobacteria, yeast and fungi septicemia. Extended incubation times (7 days for yeast, 30 days for fungi, and 42 days for mycobacteria) will permit recovery of mycobacteria and fungi when more rapidly growing organisms are not present. This medium may also be used for the culture of sterile body fluids when yeast or fungi are suspected.

Source page: https://510kreport.com/device/K970333
Methodology: https://510kreport.com/methodology