510(k) Report

FDA applicant

Roche Molecular Systems, Inc.

Pleasanton, CA70 decisions1993–202616 recalls

FDA records 70 decisions for Roche Molecular Systems, Inc. (Pleasanton, CA) from 1993 to 2026: 52 510(k) clearances, 3 De Novo grants and 15 original PMA approvals. Most are in product codes QEP (Nucleic Acid Detection System For Non-Viral…) and MZP (Assay, Hybridization And/Or Nucleic Acid…). Since 2016 its 510(k)s took a median of 171 days from receipt to decision, against 175 for FDA’s reviews in the same codes and years. Its devices cite 61 predicates, 36 of them its own earlier devices. 16 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Roche Molecular Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

11in 2025

2008: 22010: 12011: 22012: 22013: 12014: 22015: 52016: 22017: 32018: 22019: 32020: 42021: 52022: 32023: 32025: 112026 (partial year): 6
2007high 11 (2025) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2007: 22011: 22012: 12013: 12014: 12016: 12017: 12020: 12021: 1
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Roche Molecular Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Roche Molecular Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QEPNucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually…7decisions
  • MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C…6decisions
  • LSLDna-Reagents, Neisseria6decisions
  • MKZDna Probe, Nucleic Acid Amplification, Chlamydia5decisions
  • OZNC. Difficile Toxin Gene Amplification Assay5decisions
  • OWDSomatic Gene Mutation Detection System4decisions

Also: QOF (4), OCC (4), PAB (3), QQX (3), MKT (2), MAQ (2).

How long do its 510(k) reviews take?

Since 2016, its 18 510(k)s took a median of 171 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 175 days; 5 of its 18 were faster than that.

Whose devices does it build on?

Its devices cite 61 predicates; 36 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 51 times; 36 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K190433cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative…Roche Molecular Systems, Inc. · 20193cite it
  • K043576Roche Amplichip CYP450 TestRoche Molecular Systems, Inc. · 20053cite it
  • K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 20183cite it
  • K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 20123cite it
  • K202408cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 20213cite it
  • DEN200015cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc. · 20202cite it

What has FDA decided for it lately?

  • K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality…Roche Molecular Systems, Inc. · 2026
  • K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and…Roche Molecular Systems, Inc. · 2026
  • K260021cobas® BV/CVRoche Molecular Systems, Inc. · 2026
  • K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800…Roche Molecular Systems, Inc. · 2026
  • K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc. · 2026
  • K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc. · 2026
  • K243753cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc. · 2025
  • K252481cobas CMVRoche Molecular Systems, Inc. · 2025

All 70 as Roche Molecular Systems, Inc. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • P150047cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number…Sep 3, 2021Class II
  • P100020The cobas z 480 analyzer including dedicated software for IVD use is a plate-based…Nov 19, 2020Class II
  • K142721Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro…Oct 27, 2017Class II
  • P150014cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512…Jul 15, 2016Class II
  • K110923cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media…Jan 6, 2014Class II
  • K110923Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number…Mar 1, 2013Class II

Other applicant names beginning “Roche”

FDA records each applicant name separately; these may or may not be the same firm.

Roche Diagnostics Corp. 480Roche Diagnostic Systems, Inc. 296Roche Medical Electronics, Inc. 16Roche Diagnostics Operations (Rdo) 14Roche Diabetes Care, Inc. 13Roche Analytical Instruments, Inc. 11Roche Diagnostics Operations 9Roche 3Roche Diagnostics/Boehringer Mannheim GmbH 3Roche Professional Diagnostics 2Roche Molecular System, Inc. 1Roche Image Analysis Systems 1