> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Clears PhenoTest BC Kit
- URL: https://www.fdaweb.com/fda-clears-phenotest-bc-kit/
- Published: 2017-02-23T12:00:00.000Z
- Updated: 2026-09-14T22:08:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138055

FDA has cleared Accelerate Diagnostics’ PhenoTest BC Kit performed on the Pheno System, the first test to identify organisms that cause bloodstream infections and provide information about antibiotic sensitivity. An agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm543150.htm?ref=fdaweb.com) says that the test also reduces the amount of time needed to provide the information, which can guide antibiotic treatment recommendations more easily.

The test can identify 14 different species of bacteria and two species of yeast that cause bloodstream infections, while also providing antibiotic sensitivity information on 18 selected antibiotics for a subset of the identified organisms as appropriate, the release says. The test reportedly will also identify the presence of two indicators of antibiotic resistance, which can occur when potentially harmful bacteria change in a way that reduces or eliminates the effectiveness of antibiotics.

FDA’s decision to clear marketing through the de novo pathway was based largely on its review of the sponsor’s primary clinical study of 1,850 positive blood cultures for which the kit provided correct identification of the bacteria or yeast in the positive blood culture more than 95% of the time, FDA says.