FDA.reportPublic FDA data

510(k) K232092

Device
Great Basin Toxigenic C. difficile Direct Test (CDF2)
Applicant
Vela Operations USA
510(k) number
K232092
Product code
OZN
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-14
Date received
2023-07-13
Regulation
866.3130
Classification name
C. Difficile Toxin Gene Amplification Assay
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Larry Rea
Address
2441 S. 3850 W. Salt Lake City UT US 84120 84120

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OZN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243730Xpert C. difficile/EpiCepheid®2025-02-28
K212427cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.2021-10-20
K210385cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.2021-09-09
K172569GenePOC CDiffGenepoc, Inc.2017-11-22
K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.2017-09-12
K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension KitLuminex Corporation2017-07-21
K170491Solana C. difficile AssayQuidel Corporation2017-05-11
K163085Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackFocus Diagnostics, Inc.:Dba Diasorin Molecular, LLC2017-02-14
K142422cobas Cdiff TestRoche Molecular Systems, Inc.2015-05-20
K133936ARTUS C. DIFFICILE QS-RGQ MDX KITQIAGEN GmbH2014-04-04
K132726ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEMPrimeradx2013-11-29
K132235IMDX C.DIFFICILE FOR ABBOTT M2000Intelligent Medical Devices, Inc.2013-10-11
K130470BD MAX CDIFF ASSAY, BD MAX INSTRUMENTGeneohm Sciences Canada, Inc. (Bd Diagnostics)2013-04-02
K123998QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAYQuidel Corp.2013-03-08
K123355AMPLIVUE C. DIFFICILE ASSAYQuidel Corporation2012-12-13