# K183166: BacT/ALERT FA Plus; BacT/ALERT PF Plus

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 11, 2019 after 88 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: 3 generations back to K992400 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121461: Bact/Alert FA Plus Culture Bottle, bioMerieux, Inc. (2013) Summary page 4.
- K121446: Bact/Alert PF Plus Culture Bottle, bioMerieux, Inc. (2013) Summary page 4.

## Indications for use
BacT/ALERT® FA Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood and other normally sterile body fluids. BacT/ALERT® PF Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.

Source page: https://510kreport.com/device/K183166
Methodology: https://510kreport.com/methodology