Atlas FDA

cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit

FDA 510(k) clearance K190433 · decided 2019-05-22

Clearance details

K-number
K190433
Device name
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
Applicant
Roche Molecular Systems, Inc.
Decision
Substantially Equivalent
Date received
2019-02-22
Decision date
2019-05-22
Days to decision
89 days
Clearance type
Traditional
Product code
QEP
Device class
2
Regulation number
866.3393
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Pleasanton, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (K260917)Roche Molecular Systems, Inc.2026-07-08
cobas liat CT/NG/MG nucleic acid test (K253759)Roche Molecular Systems, Inc.2026-05-15
cobas liat CT/NG nucleic acid test (K253756)Roche Molecular Systems, Inc.2026-05-15
Visby Medical Men's Sexual Health Test (K251501)Visby Medical, Inc.2025-10-01
BD CTGCTV2 (K243343)Bd Integrated Diagnostic Solutions/Becton,2025-04-22
cobas® liat CT/NG nucleic acid test (K240217)Roche Molecular Systems, Inc.2025-01-17
cobas® liat CT/NG/MG nucleic acid test (K240197)Roche Molecular Systems, Inc.2025-01-16
NeuMoDx CT/NG Assay 2.0 (K230267)Neumodx Molecular, Inc.2023-12-22
Visby Medical Sexual Health Test (K220407)Visby Medical2023-03-07
Alinity m STI Assay (K222379)Abbott Molecular, Inc.2023-03-03
Aptima 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) Tigris (K220321)Hologic, Inc.2022-06-03
BD CTGCTV2 (K210585)Becton, Dickinson and Company2022-05-10

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
cobas HPV (P190028/S023)Roche Molecular Systems, Inc.2026-06-16
cobas® HPV (P190028/S024)Roche Molecular Systems, Inc.2026-04-23
cobas® HPV (P190028/S025)Roche Molecular Systems, Inc.2026-03-17
cobas® KRAS Mutation Test (P140023/S032)Roche Molecular Systems, Inc.2026-03-17
cobas® HPV (P100020/S065)Roche Molecular Systems, Inc.2026-03-17
cobas® BRAF V600 Mutation Test (P110020/S044)Roche Molecular Systems, Inc.2026-03-17
cobas® HPV (P190028/S022)Roche Molecular Systems, Inc.2025-12-31
cobsa® BRAF V600 Mutation Test (P110020/S043)Roche Molecular Systems, Inc.2025-12-31