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# FDA Clears GenePOC Carba Assay
- URL: https://www.fdaweb.com/fda-clears-genepoc-carba-assay/
- Published: 2019-05-16T12:00:00.000Z
- Updated: 2026-09-15T01:27:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144129

FDA has cleared a GenePOC 510(k) for the Carba assay and its use with the Revogene device to detect carbapenem-producing organisms (CPO). CPOs are known to be resistant to commonly used antibiotics and occasionally completely resistant to all available antibiotics, the compamy says.

The qualitative, *in vitro* diagnostic test is designed for the detection and differentiation of the *bla*KPC, *bla*NDM, *bla*VIM, *bla*OXA-48-like, and *bla*IMP gene sequences associated with carbapenem-non-susceptibility, according to GenePOC. It says the assay can provide results for one to eight samples in about an hour using characterized carbapenem-non-susceptible pure colonies of *Enterobacteriaceae, Acinetobacter baumannii,* or *Pseudomonas aeruginosa.*

Revogene is an automated and stand-alone device, the company says, enabling testing of single-use proprietary microfluidic cartridges with fluorescence-based real-time polymerase chain reaction technology to deliver a diagnosis.