FDA.reportPublic FDA data

510(k) K230440

Device
Xpert® Xpress CoV-2 plus
Applicant
Cepheid®
510(k) number
K230440
Product code
QQX
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-13
Date received
2023-02-21
Regulation
866.3981
Classification name
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Suzette Chance
Address
904 Caribbean Dr. Sunnyvale CA US 94089 94089

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QQX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243396Aptima SARS-CoV-2 AssayHologic, Inc.2025-02-13
K240867cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 SystemsRoche Molecular Systems, Inc.2025-02-11
K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)Cepheid®2025-01-15
K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott Molecular2024-12-06
K233453Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitLife Technologies Corporation2024-07-10
K231306cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc.2023-06-01
K213804cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc.2022-10-22
K212147Simplexa COVID-19 DirectDiasorin Molecular, LLC2022-09-13
K221460BioFire COVID-19 Test 2Biofire Defense, LLC2022-07-25
K211079BioFire COVID-19 Test 2Biofire Defense, LLC2021-11-01