FDA.reportPublic FDA data

510(k) K200533

Device
binx io CT/NG Assay and binx io CT/NG System
Applicant
Binx Health, Inc.
510(k) number
K200533
Product code
QEP
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-27
Date received
2020-03-02
Regulation
866.3393
Classification name
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sarah Kalil
Address
77 N. Washington St., 5th Floor Boston MA US 02114 02114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QEP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.2026-05-15
K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.2026-05-15
K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.2025-10-01
K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,2025-04-22
K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.2025-01-17
K240197cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.2025-01-16
K230267NeuMoDx CT/NG Assay 2.0Neumodx Molecular, Inc.2023-12-22
K220407Visby Medical Sexual Health TestVisby Medical2023-03-07
K222379Alinity m STI AssayAbbott Molecular, Inc.2023-03-03
K220321Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) TigrisHologic, Inc.2022-06-03
K210585BD CTGCTV2Becton, Dickinson and Company2022-05-10
K202977Alinity m STI AssayAbbott Molecular, Inc.2022-04-29
K193081Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection KitRheonix, Inc.2021-12-17
K200748Visby Medical Sexual HealthVisby Medical2021-08-26
K202408cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.2021-01-21