# K014123: Bactec Mgit 960 Sire Kits

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Apr 19, 2002 after 123 days
- Product code: MJA (Susceptibility Test Powders, Antimycobacterial)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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) Method of Proportion agar plates: named in the summary without a submission number
- (no number) BACTEC® 460TB SIRE Kit: named in the summary without a submission number

## Indications for use
The BACTEC® MGIT™ 960 SIRE Kit is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin (STR), isoniazid (INH), rifampin (RIF) and ethambutol (EMB). The BACTEC® MGIT™ 960 STR 4.0 Kit and the BACTEC® MGIT™ 960 INH 0.4 Kit are for testing at higher drug concentrations. The BACTEC® MGIT™ 960 SIRE kits are used with the BACTEC® MGIT™ 960 System. The BACTEC® MGIT™ 960 SIRE Kit final test concentrations are 1.0 pg/mL for streptomycin, 0.1 pg/mL for isoniazid, 1.0 pg/mL for rifampin and 5.0 ug/mL for ethambutol. The BACTEC® MGIT™ 960 STR 4.0 Kit final test concentration is 4.0 pg/mL for streptomycin and the BACTEC® MGIT™ 960 INH 0.4 Kit final test concentration is 0.4 pg/mL for isoniazid.

Source page: https://510kreport.com/device/K014123
Methodology: https://510kreport.com/methodology