# K993576: Bact/Alert MP Process Bottle

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Dec 14, 1999 after 54 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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 Process Bottles: named in the summary without a submission number

## Most influential descendants
- K031737: Bact/Alert MP Culture Bottles (Plastic) (2003), 1 descendant of its own
- K190405: BACT/ALERT MP Reagent System (2019), 0 descendants of its own

## Indications for use
The BacT/ALERT MP Process Bottle is designed for use with the MB/BacT and the BacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.

Source page: https://510kreport.com/device/K993576
Methodology: https://510kreport.com/methodology