Company · US
Roche Molecular Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2026. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (7 in 12 months)
66recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NSX | 10 | |
| LSL | Dna-Reagents, Neisseria | 8 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 7 |
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | 7 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 7 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 7 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | 6 |
| OWD | Somatic Gene Mutation Detection System | 6 |
| JJH | Clinical Sample Concentrator | 5 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 5 |
| NTI | Drug Metabolizing Enzyme Genotyping Systems | 4 |
| OOI | Real Time Nucleic Acid Amplification System | 4 |
| QLT | Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices | 4 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 4 |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 3 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 3 |
| MAQ | Kit, Dna Detection, Human Papillomavirus | 2 |
| MWA | System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex | 2 |
| NPR | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | 2 |
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2026 | K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402 Roche Molecular Systems, Inc. | PGX |
| Aug 28, 2026 | K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Cont Roche Molecular Systems, Inc. | OZN |
| Jul 16, 2026 | K260021 | cobas® BV/CV Roche Molecular Systems, Inc. | PQA |
| Jul 8, 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 Roche Molecular Systems, Inc. | QEP |
| May 15, 2026 | K253759 | cobas liat CT/NG/MG nucleic acid test Roche Molecular Systems, Inc. | QEP |
| May 15, 2026 | K253756 | cobas liat CT/NG nucleic acid test Roche Molecular Systems, Inc. | QEP |
| Nov 20, 2025 | K243753 | cobas liat Bordetella panel nucleic acid test Roche Molecular Systems, Inc. | OZZ |
| Nov 3, 2025 | K252484 | cobas HCV Roche Molecular Systems, Inc. | MZP |
| Nov 3, 2025 | K252481 | cobas CMV Roche Molecular Systems, Inc. | PAB |
| Jul 31, 2025 | K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems Roche Molecular Systems, Inc. | QOF |
| May 30, 2025 | K243863 | Opulus Lymphoma Precision Roche Molecular Systems, Inc. | QIH |
| Apr 25, 2025 | K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test Roche Molecular Systems, Inc. | QOF |
| Apr 25, 2025 | K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test Roche Molecular Systems, Inc. | QOF |
| Apr 11, 2025 | K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test Roche Molecular Systems, Inc. | QWR |
| Feb 11, 2025 | K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems Roche Molecular Systems, Inc. | QQX |
| Jan 17, 2025 | K240217 | cobas® liat CT/NG nucleic acid test Roche Molecular Systems, Inc. | QEP |
| Jan 16, 2025 | K240197 | cobas® liat CT/NG/MG nucleic acid test Roche Molecular Systems, Inc. | QEP |
| Dec 4, 2023 | K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. | QWR |
| Jul 27, 2023 | K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System Roche Molecular Systems, Inc. | QOF |
| Jun 1, 2023 | K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems Roche Molecular Systems, Inc. | QQX |
| Nov 4, 2022 | K221007 | cobas HCV Roche Molecular Systems, Inc. | MZP |
| Oct 22, 2022 | K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems Roche Molecular Systems, Inc. | QQX |
| Jul 6, 2022 | K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. | OCC |
| Oct 20, 2021 | K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. | OZN |
| Sep 9, 2021 | K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. | OZN |
| Feb 16, 2021 | K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. | OCC |
| Jan 29, 2021 | K203220 | cobas BKV Roche Molecular Systems, Inc. | QLX |
| Jan 21, 2021 | K202408 | cobas CTNG for use on cobas 6800/8800 systems Roche Molecular Systems, Inc. | QEP |
| Sep 2, 2020 | K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc. | QMI |
| Jul 30, 2020 | DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc. | QLX |
| Feb 10, 2020 | K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for Roche Molecular Systems, Inc. | OCC |
| Dec 5, 2019 | DEN190016 | cobas vivoDx MRSA Roche Molecular Systems, Inc. | QIV |
| Jul 24, 2019 | K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System Roche Molecular Systems, Inc. | OCC |
| May 22, 2019 | K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc. | QEP |
| Mar 21, 2018 | K173887 | cobas CT/NG for use on cobas 6800/8800 systems Roche Molecular Systems, Inc. | LSL |
| Jan 12, 2018 | K172913 | cobas Factor II and Factor V Test Roche Molecular Systems, Inc. | NPR |
| Sep 12, 2017 | K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. | OZN |
| Feb 9, 2017 | K163184 | cobas® CT/NG v2.0 Test Roche Molecular Systems, Inc. | LSL |
| Jun 1, 2015 | K150617 | cobas HSV 1 and 2 Test Roche Molecular Systems, Inc. | OQO |
| May 20, 2015 | K142422 | cobas Cdiff Test Roche Molecular Systems, Inc. | OZN |
| Dec 17, 2014 | K142721 | cobas MRSA/SA Test Roche Molecular Systems, Inc. | NQX |
| May 5, 2014 | K140887 | COBAS CT/NG V2.0 TEST Roche Molecular Systems, Inc. | LSL |
| Dec 2, 2013 | K132270 | COBAS CT/NG V2.0 TEST Roche Molecular Systems, Inc. | LSL |
| Jan 24, 2012 | K110923 | COBAS 4800 CT / NG TEST Roche Molecular Systems, Inc. | MKZ |
| Jul 6, 2010 | K091409 | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 Roche Molecular Systems, Inc. | NQX |
| Jan 10, 2005 | K043576 | ROCHE AMPLICHIP CYP450 TEST Roche Molecular Systems, Inc. | NTI |
| Dec 23, 2004 | DEN040011 | AMPLICHIP CYP450 TEST, MODEL 04381866190 Roche Molecular Systems, Inc. | NTI |
| Feb 1, 2002 | K012966 | ROCHE COBAS TAQMAN ANALYZER Roche Molecular Systems, Inc. | JJF |
| Dec 1, 1999 | K974503 | ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE Roche Molecular Systems, Inc. | LSL |
| Aug 4, 1999 | K973707 | ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS Roche Molecular Systems, Inc. | MKZ |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2023 | Roche Molecular Systems, Inc. cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190 Open, Classified |
QLT | None listed |
| Feb 7, 2023 | Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190 Open, Classified |
QLT | None listed |
| Feb 7, 2023 | Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190 Open, Classified |
QLT | None listed |
| Oct 17, 2022 | Roche Molecular Systems, Inc. cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings. Terminated |
NSU | None listed |
| Nov 16, 2021 | Roche Molecular Systems, Inc. cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190 Open, Classified |
OOI | K111387 |
| Sep 3, 2021 | Roche Molecular Systems, Inc. cobas EGFR Mutation Test v2-Somatic gene mutation detection system
Catalog Number :07248563190 Open, Classified |
OWD | None listed |
| Aug 4, 2021 | Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190 Terminated |
QLT | None listed |
| Mar 25, 2021 | Roche Molecular Systems, Inc. cobas Liat Analyzer: respiratory virus panel nucleic acid assay system
Catalog Number: 07341920190 Open, Classified |
QJR | None listed |
| Mar 25, 2021 | Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System,
Catalog Number: 09211101190 Open, Classified |
QJR | None listed |
| Nov 23, 2020 | Roche Molecular Systems, Inc. uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 Terminated |
NQN | K140465 |
| Nov 19, 2020 | Roche Molecular Systems, Inc. The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro di Terminated |
MAQ | None listed |
| Jun 3, 2020 | Roche Molecular Systems, Inc. MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purific Terminated |
JJH | None listed |
| May 2, 2018 | Roche Molecular Systems, Inc. MagNA Pure 24 System, GMMI: 07290519001
Product Usage:
The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and Terminated |
JJH | None listed |
| Oct 27, 2017 | Roche Molecular Systems, Inc. Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic. Terminated |
NQX | K142721 |
| Nov 16, 2016 | Roche Molecular Systems, Inc. LightMix Zika rRT-PCR Test
The LightMix Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting Terminated |
POA | None listed |
| Jul 13, 2016 | Roche Molecular Systems, Inc. cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay. Terminated |
OCC | K111387 |
| May 9, 2016 | Roche Molecular Systems, Inc. cobas Liat Analyzer Terminated |
OCC | K111387 |
| Apr 27, 2016 | Roche Molecular Systems, Inc. Hand-Held Scanner USB IT3800
For sample identification and tracking when used with various systems Terminated |
JJH | None listed |
| Apr 5, 2016 | Roche Molecular Systems, Inc. cobas EGFR Mutation Test V2
Materials number
CE-IVD: EGFR v2: 07248563190
cfDNA: 07247737190
Device Identifier:
EGFR v2.0: 00875197005448
cfDNA: 00875197005424
Product Usage:
A real time PCR Test f Terminated |
OWD | None listed |
| Mar 15, 2016 | Roche Molecular Systems, Inc. cobas EGFR Mutation Test, v2 and cobas cfDNA Sample
Preparation Hungarian Translation Instructions for Use Terminated |
OWD | None listed |
| Sep 2, 2015 | Roche Molecular Systems, Inc. cobas Liat Analyzer, for in vitro diagnostic use. Terminated |
OCC | K111387 |
| Jun 26, 2015 | Roche Molecular Systems, Inc. cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190.
Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-e Terminated |
OWD | None listed |
| Mar 25, 2015 | Roche Molecular Systems, Inc. cobas EGFR Mutation Test
epidermal growth factor receptor (EGFR) gene DNA assay Terminated |
OWD | None listed |
| Feb 26, 2014 | Roche Molecular Systems, Inc. cobas PCR Urine Kit 100 PKT IVD
cobas PCR Female Swab Kit 100 PKT IVD
cobas PCR media 100T IVD
cobas PCR Female Swab Kit 100 PKT JPN-IVD
Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA
Roche Terminated |
OOI | K110923 |
| Sep 10, 2013 | Roche Molecular Systems, Inc. KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD
Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA
Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA
Terminated |
MAQ | None listed |
| May 21, 2013 | Roche Molecular Systems, Inc. cobas 4800 system z480 instrument.
Integrates fully automated total nucleic acid isolation directly from secondary sample tubes. Terminated |
OOI | None listed |
| Jan 31, 2013 | Roche Molecular Systems, Inc. COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. Terminated |
MWA | None listed |
| Dec 23, 2012 | Roche Molecular Systems, Inc. COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5
Automated sample processing instrument used with CAP/CA and CAP/CTM.
Roche Molecular Systems, Inc.
1080 US Highway 202 South
Bra Terminated |
JJH | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data. Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data. Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems. Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide rang Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualita Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instr Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials. Terminated |
NSX | None listed |
| Dec 7, 2012 | Roche Molecular Systems, Inc. Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS AmpliPrep instrument, COBAS TaqMan analyzer, COBAS TaqMan 48 analyzer, COBAS AMPLICOR analyzer Terminated |
NSX | None listed |
| Nov 2, 2012 | Roche Molecular Systems, Inc. cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc.,
Product Usage:
The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V6 Terminated |
OWD | None listed |
| Sep 18, 2012 | Roche Molecular Systems, Inc. Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System. Terminated |
OYT | None listed |
| Aug 15, 2012 | Roche Molecular Systems, Inc. COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode Terminated |
JJF | None listed |
| Aug 8, 2012 | Roche Molecular Systems, Inc. Cobas KRAS Mutation Test for In Vitro Diagnostic Use
Product Usage: Usage:
The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification o Terminated |
OOI | None listed |
| Jun 17, 2011 | Roche Molecular Systems, Inc. COBAS AmpliPrep / COBAS TaqMan HCV Test, CE-IVD
The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C Virus (HCV) RNA in human p Terminated |
MZP | None listed |
| Jun 17, 2011 | Roche Molecular Systems, Inc. COBAS AmpliPrep / COBAS TaqMan HCV Test, US-IVD
The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA in human p Terminated |
MZP | None listed |
| Jun 14, 2011 | Roche Molecular Systems, Inc. Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA; Distributed by Roche Diagnostics Indianapolis, IN 46266 USA; 0361017900 Terminated |
NPQ | None listed |
| Jun 14, 2011 | Roche Molecular Systems, Inc. Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA DisFor use with Light Cycler 2.0 instrument;
The Facto Terminated |
JPF | None listed |
| Mar 1, 2011 | Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD;
COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD Terminated |
MKT | None listed |
| Mar 5, 2010 | Roche Molecular Systems, Inc. FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001
Cont.
1 FIIG20210A MD Mix, 1 x 78 uL
2. FIIG20210A R mix, 1 x 78 uL
3. FIIG20210A CT, 1 x 50 uL
5, FIIG20 Terminated |
NPR | K033612 |
| Aug 27, 2009 | Roche Molecular Systems, Inc. AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 0509323 Terminated |
JJH | None listed |
| Aug 2, 2007 | Roche Molecular Systems, Inc. Amplilink Software Versions 1.1, 1.3, 1.4, 2.41
COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0 Terminated |
MZP | None listed |
Newest 50 of 66.