# K020813: Bact/Alert FA Culture Bottle

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Apr 17, 2002 after 35 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992400 (1999). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992400: Bactalert FA, Organon Teknika Corp. (1999) Summary page 2.

## Most influential descendants
- K121461: Bact/Alert FA Plus Culture Bottle (2013), 1 descendant of its own
- K183166: BacT/ALERT FA Plus; BacT/ALERT PF Plus (2019), 0 descendants of its own

## Recalls of this device
- Dec 24, 2015 · Class II · Z-0750-2016: Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
- Apr 13, 2011 · Not classified · Z-2244-2011: The charcoal suspension in a portion of the lot does not meet the intended density.
- Jan 11, 2007 · Not classified · Z-0643-2007: Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.

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

Source page: https://510kreport.com/device/K020813
Methodology: https://510kreport.com/methodology