Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
FDA 510(k) K190441 · Cepheid
Submission
- Device name
- Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
- Applicant
- Cepheid
Sunnyvale, CA, US - Received
- February 25, 2019
- Decision date
- May 23, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEP – Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3393
- Specialty
- Microbiology
A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually…
Other 510(k)s with product code QEP
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|---|---|---|---|
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…QEP · Traditional | Roche Molecular Systems, Inc. | 07/08/2026SE |
| K253759 | cobas liat CT/NG/MG nucleic acid testQEP · Dual Track | Roche Molecular Systems, Inc. | 05/15/2026SE |
| K253756 | cobas liat CT/NG nucleic acid testQEP · Dual Track | Roche Molecular Systems, Inc. | 05/15/2026SE |
| K251501 | Visby Medical Men's Sexual Health TestQEP · Dual Track | Visby Medical, Inc. | 10/01/2025SE |
| K243343 | BD CTGCTV2QEP · Traditional | Bd Integrated Diagnostic Solutions/Becton, | 04/22/2025SE |
| K240217 | cobas® liat CT/NG nucleic acid testQEP · Dual Track | Roche Molecular Systems, Inc. | 01/17/2025SE |
| K240197 | cobas® liat CT/NG/MG nucleic acid testQEP · Dual Track | Roche Molecular Systems, Inc. | 01/16/2025SE |
| K230267 | NeuMoDx CT/NG Assay 2.0QEP · Traditional | Neumodx Molecular, Inc. | 12/22/2023SE |
| K220407 | Visby Medical Sexual Health TestQEP · Dual Track | Visby Medical | 03/07/2023SE |
| K222379 | Alinity m STI AssayQEP · Traditional | Abbott Molecular, Inc. | 03/03/2023SE |
More from Abbott Molecular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261362 | Xpert Hemorrhagic FeverQVR · Dual Track | 08/07/2026SE |
| K261867 | Xpert Carba-RPOC · Special | 07/02/2026SE |
| K253653 | Xpert Hemorrhagic Fever · Traditional | 02/20/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | 01/16/2026SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K243730 | Xpert C. difficile/EpiOZN · Traditional | 02/28/2025SE |
| K250218 | Xpert® FII & FVNPR · Special | 02/21/2025SE |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track | 01/15/2025SE |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Dual Track | 01/10/2025SE |
Questions and answers
When was Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit cleared by the FDA?
Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit (K190441) received a 510(k) decision of Substantially Equivalent on May 23, 2019, 87 days after the submission was received.
What is the product code of K190441?
The FDA product code is QEP – Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, a Class II (moderate risk) device regulated under 21 CFR 866.3393.