# K974883: Bactec Mgit 960 System

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: May 1, 1998 after 122 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: 2 (0 Class I)
- 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® 460 TB System: named in the summary without a submission number
- (no number) Conventional Media: named in the summary without a submission number

## Recalls of this device
- Sep 9, 2013 · Class II · Z-0028-2014: An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.
- Mar 28, 2011 · Not classified · Z-2890-2011: Software contained three additional set configurations which caused the system to reinitialized the AST set carrier defaults.

## Indications for use
The BACTEC® MGIT™ 960 System is an in vitro diagnostic instrument designed and optimized for the rapid detection of mycobacteria from clinical specimens (except blood and urine). Samples are collected from patients, processed and inoculated into BBL® MGIT™ 7mL tubes supplemented with BBL® MGIT™ PANTA™ and BBL® MGIT™ OADC.

Source page: https://510kreport.com/device/K974883
Methodology: https://510kreport.com/methodology