# K972758: Bactec Myco/F-Sputa Culture Vials

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Aug 8, 1997 after 53 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.
No later device cites it as a predicate yet.
0 of 1 device 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 460TB System: named in the summary without a submission number
- (no number) Conventional Media: named in the summary without a submission number

## Indications for use
MYCO/F-Sputa culture media with the addition of BACTEC Supplement/F when used with the BACTEC Brand 9000MB fluorescent series instrument is a qualitative test for the in-vitro culture and recovery of mycobacteria from digested decontaminated clinical specimens and sterile body fluids other than blood from patients suspected of pulmonary or disseminated mycobacterial infection.

Source page: https://510kreport.com/device/K972758
Methodology: https://510kreport.com/methodology