# K190405: BACT/ALERT MP Reagent System

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: May 15, 2019 after 85 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
Longest line of descent: 2 generations back to K993576 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031737: Bact/Alert MP Culture Bottles (Plastic), bioMerieux, Inc. (2003) Summary page 4.

## Indications for use
The BACT/ALERT® MP Reagent System consists of the BACT/ALERT® MP culture bottle with a removable closure used in conjunction with the BACT/ALERT® MP Antimicrobial Supplement and the BACT/ALERT® MP Nutrient Supplement. The BACT/ALERT® MP Reagent System is designed for use with 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/K190405
Methodology: https://510kreport.com/methodology