cobas CT/NG for use on cobas 6800/8800 systems
FDA 510(k) K173887 · Roche Molecular Systems, Inc.
510(k) numberK173887
Submission
- Device name
- cobas CT/NG for use on cobas 6800/8800 systems
- Applicant
- Roche Molecular Systems, Inc.
Pleasanton, CA, US - Received
- December 21, 2017
- Decision date
- March 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LSL – Dna-Reagents, Neisseria
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Specialty
- Microbiology
Other 510(k)s with product code LSL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231329 | Aptima Neisseria gonorrhoeae AssayLSL · Traditional | Hologic, Inc. | 01/26/2024SE |
| K180681 | Aptima Combo 2 Assay (Panther System)LSL · Traditional | Hologic, Inc. | 06/13/2018SE |
| K173840 | Xpert CT/NGLSL · Traditional | Cepheid | 03/16/2018SE |
| K163184 | cobas® CT/NG v2.0 TestLSL · Traditional | Roche Molecular Systems, Inc. | 02/09/2017SE |
| K140448 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | Becton, Dickinson & CO | 05/20/2014SE |
| K140354 | Abbott Multi-Collect Specimen Collection Kit, Abbott Real Time Ct/NgLSL · Traditional | Abbott Molecular, Inc. | 05/09/2014SE |
| K140887 | Cobas Ct/Ng V2.0 TestLSL · Special | Roche Molecular Systems, Inc. | 05/05/2014SE |
| K132270 | Cobas Ct/Ng V2.0 TestLSL · Traditional | Roche Molecular Systems, Inc. | 12/02/2013SE |
| K132251 | Aptima Combo 2 Assay (Panther System)LSL · Traditional | Hologic / Gen-Probe Incorporated | 10/17/2013SE |
| K121710 | Xpert Ct/NgLSL · Traditional | Cepheid | 12/27/2012SE |
More from Cepheid
| 510(k) | Device | Decision |
|---|---|---|
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…PGX · Traditional | 08/28/2026SE |
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…OZN · Traditional | 08/28/2026SE |
| K260021 | cobas® BV/CVPQA · Traditional | 07/16/2026SE |
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…QEP · Traditional | 07/08/2026SE |
| K253759 | cobas liat CT/NG/MG nucleic acid testQEP · Dual Track | 05/15/2026SE |
| K253756 | cobas liat CT/NG nucleic acid testQEP · Dual Track | 05/15/2026SE |
| K243753 | cobas liat Bordetella panel nucleic acid testOZZ · Dual Track | 11/20/2025SE |
| K252484 | cobas HCVMZP · Traditional | 11/03/2025SE |
| K252481 | cobas CMVPAB · Traditional | 11/03/2025SE |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional | 07/31/2025SE |
Questions and answers
When was cobas CT/NG for use on cobas 6800/8800 systems cleared by the FDA?
cobas CT/NG for use on cobas 6800/8800 systems (K173887) received a 510(k) decision of Substantially Equivalent on March 21, 2018, 90 days after the submission was received.
What is the product code of K173887?
The FDA product code is LSL – Dna-Reagents, Neisseria, a Class II (moderate risk) device regulated under 21 CFR 866.3390.