# K981736: Bact/Alert 3D Microbial Detection System

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Jul 24, 1998 after 67 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) MB/BacT Mycobacteria Culture System: 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-0776-2007: 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
THE BACT/ALERT 3D MICROBIAL DETECTION SYSTEM WITH EXPANDED MYCOBACTERIA INDICATION IS USED IN QUALITATIVE PROCEDURES FOR GROWTH AND DETECTION OF MYCOBACTERIA IN CLINICAL SPECIMENS OTHER THAN BLOOD.

Source page: https://510kreport.com/device/K981736
Methodology: https://510kreport.com/methodology