# Roche Molecular Systems, Inc.

- Location (FDA's records): Pleasanton, CA
- FDA decisions: 70 (1993–2026): 52 510(k) clearances, 3 De Novo grants and 15 original PMA approvals
- Product codes: QEP (7), MZP (6), LSL (6), MKZ (5), OZN (5), OWD (4), QOF (4), OCC (4), PAB (3), QQX (3), MKT (2), MAQ (2)
- 510(k) review time since 2016: median 171 days, against 175 for FDA's reviews in the same codes and years (5 of 18 faster)
- Predicates its devices cite: 61 (36 its own); citations of its devices by later devices: 51 (36 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Becton, Dickinson & CO: 3 (https://510kreport.com/company/becton-dickinson)
- Hologic, Inc.: 3 (https://510kreport.com/company/hologic)
- Iquum, Inc.: 3 (https://510kreport.com/company/iquum)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Biofire Diagnostics, LLC: 2 (https://510kreport.com/company/biofire-diagnostics)
- Geneohm Sciences Canada, Inc. (Bd Diagnostics): 2 (https://510kreport.com/company/geneohm-sciences-canada-bd-diagnostics)
- Infectio Diagnostic (I.D.I.), Inc.: 2 (https://510kreport.com/company/infectio-diagnostic-idi)
- Abbott Diagnostics Scarborough, Inc.: 1 (https://510kreport.com/company/abbott-diagnostics-scarborough)

## Firms that cite its devices most
- Roche Diagnostics Corp.: 5 (https://510kreport.com/company/roche-diagnostics)
- Abbott Molecular, Inc.: 4 (https://510kreport.com/company/abbott-molecular)
- Autogenomics, Incorporated: 2 (https://510kreport.com/company/autogenomics)
- Third Wave Technologies, Inc.: 1 (https://510kreport.com/company/third-wave-technologies)
- Cepheid: 1 (https://510kreport.com/company/cepheid)
- Lex Diagnostics Limited: 1 (https://510kreport.com/company/lex-diagnostics)
- Luminex Molecular Diagnostics, Inc.: 1 (https://510kreport.com/company/luminex-molecular-diagnostics)

## Its most-cited devices
- K190433: cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit (2019), cited by 3
- K043576: Roche Amplichip CYP450 Test (2005), cited by 3
- K173887: cobas CT/NG for use on cobas 6800/8800 systems (2018), cited by 3
- K110923: Cobas 4800 CT / NG Test (2012), cited by 3
- K202408: cobas CTNG for use on cobas 6800/8800 systems (2021), cited by 3
- DEN200015: cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (2020), cited by 2

## Recent decisions
- K260047: cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) (Aug 28, 2026)
- K260045: cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) (Aug 28, 2026)
- K260021: cobas® BV/CV (Jul 16, 2026)
- K260917: cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (Jul 8, 2026)
- K253759: cobas liat CT/NG/MG nucleic acid test (May 15, 2026)
- K253756: cobas liat CT/NG nucleic acid test (May 15, 2026)
- K243753: cobas liat Bordetella panel nucleic acid test (Nov 20, 2025)
- K252481: cobas CMV (Nov 3, 2025)

Source page: https://510kreport.com/company/roche-molecular-systems