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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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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 The cobas¿ HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas¿ HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas¿ HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas¿ HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas¿ HPV Test include the following liquid based collection media and collection device: " ThinPrep¿ Pap TestTM PreservCyt¿ Solution " Endocervical Brush/Spatula
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·September 18, 2013
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, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
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 range of analytes in various body fluids.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
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 instrument. There are no corresponding assays.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
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 qualitative and quantitative in-vitro determinations using a wide variety of tests.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
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.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
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 curve analysis with corresponding assays.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
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 by melting curve analysis.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
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 Branchburg, NJ 08876 USA Made in Switzerland
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·January 2, 2013
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 Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·March 5, 2014
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
FDA Enforcement
Class II
·Ongoing·Roche Molecular Systems, Inc.·February 15, 2023
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
FDA Enforcement
Class II
·Ongoing·Roche Molecular Systems, Inc.·February 15, 2023
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
FDA Enforcement
Class II
·Ongoing·Roche Molecular Systems, Inc.·February 15, 2023
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·April 4, 2018
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 CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. ¿263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present). Positive results are indicative of current infection. Laboratories are required to report all positive results to the appropriate public health authorities. Within the United States and its territories positive results must be reported to appropriate state/local public health authorities. Negative results do not preclude Zika virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The LightMix¿ Zika rRT-PCR Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of realtime PCR and in vitro diagnostic procedures. The Test is only for use under the Food and Drug Administration s Emergency Use Authorization.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 21, 2016
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 to identify the sample.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·August 22, 2012
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·February 6, 2013