# K954468: MB/Bact Mycrobacteria Detection System

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Jul 22, 1996 after 300 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) Lowenstein Jensen (LJ) slants: named in the summary without a submission number
- (no number) Middlebrook 7H11 solid media: named in the summary without a submission number
- (no number) Bactec 460: named in the summary without a submission number

## Recalls of this device
- Dec 19, 2006 · Not classified · Z-0644-2007: Bottle data is not sent to BacT/ALERT 3D instrument.
- Aug 14, 2006 · Not classified · Z-0775-2007: Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.

## Indications for use
MB/BacT Process bottles are used with the MB/BacT Mycobacteria Detection System in qualitative procedures for recovery and detection of mycobacteria in clinical specimens other than blood.

Source page: https://510kreport.com/device/K954468
Methodology: https://510kreport.com/methodology