510(k) K243405

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

November 21, 2024

Date Received

November 1, 2024

Clearance Type

Special

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Device Class

Class II

Regulation Number

866.1640

Review Panel

MI

Submission Type

The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology