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In Vitro Diagnostic Medical Device Regulation

Overview
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By your side through IVDR

The European In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 came into effect on 26 May 2017 and will replace the European In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC. A global cross-functional team at BD Biosciences has been working to implement the new regulation in a seamless and compliant manner.

 

We are committed to providing IVDR compliant solutions to continue delivering safe and effective IVD medical devices to serve you and your patients. We received our first IVDR product certification in December 2020 and are continuing our efforts to achieve this for other products in our clinical portfolio.

 

The BD Biosciences reagent portfolio planned for IVDR compliance includes in vitro diagnostic solutions for*

  • Flow cytometric immunophenotyping of haematological disorders.
  • Monitoring human immunodeficiency virus (HIV)–infected individuals.
  • Characterising and monitoring immunodeficiency and autoimmune diseases.
  • Cell enumeration of blood products for transfusion and stem cell transplantation procedures.

 

The BD Biosciences IVDR portfolio will also include flow cytometers and automation solutions.

 

*After the IVDR date of application, the products indicated on this page will be made available as IVDR compliant devices and/or as IVDD compliant devices

 

 

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Reagents and Assay
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BD’s portfolio of reagents planned for IVDR compliance

 

The new IVDR sets high standards of quality and safety for in vitro diagnostic medical devices to ensure the highest level of public health protection.After the IVDR date of application, the products indicated on this page will be made available as IVDR compliant devices and/or as IVDD compliant devices.

Haematological malignancies

Leukemia and lymphoma are complex multifactorial diseases and their diagnosis requires an interdisciplinary approach.

 

BD offers the BD OneFlow™ solution specifically designed for flow cytometry as an aid in the diagnosis of hematological malignancies.

 

Built on the research and validation work of the EuroFlow™ Consortium on the characterisation of hematological malignancies for improved diagnostic outcomes1, the BD OneFlow™ solution brings the standardisation of leukemia and lymphoma immunophenotyping one step forward. It is made of a comprehensive set of reagents, protocols and assay templates to set up the flow cytometer, stain, acquire and analyse patient samples for immunophenotyping of normal and aberrant cell populations.

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BD OneFlow™ solution improves laboratory efficiency and enhances the reliability and accuracy of results for clinical decisions and ultimately, can lead to better patient outcomes.2,3

 

In addition, BD Biosciences offers a growing portfolio of antigen-fluorochrome combinations to choose from, for dim to very bright antigen expression. Our single-colour reagents are manufactured in a GMP-certified facility.

 

Contact us to learn which BD single-colour reagents are planned for IVDR compliance.

 

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Lymphocyte subsets

The BD Multitest™ Reagents are multicolor reagents that can be used with suitable flow cytometers to identify and determine the percentages and absolute counts of lymphocyte subsets in peripheral blood. BD Biosciences offers a choice of several reagent formats for lymphocyte subset testing and appropriate process controls.

 

BD™ Multi-Check Control and BD™ Multi-Check CD4 Low Control are stable two-level controls with assigned values that can be used to monitor the immunophenotyping process.

 

Contact us to learn which BD Multitest™ Reagents in our portfolio are planned for IVDR compliance. 

 

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Stem cell enumeration

The BD® Stem Cell Enumeration Kit with BD Trucount™ Tubes offers a single-tube, single-platform assay for accurate, reproducible, and rapid enumeration of CD34+ hematopoietic progenitor cells in a wide range of stem cell sources. An accurate measure of the CD34 cell count is necessary for dose requirement protocols in stem cell transplantation.

 

The BD® Stem Cell Control is intended as a complete, two-level process control with assigned values to monitor the immunophenotyping process for CD34+ cells. 

 

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Enumeration of residual White Blood Cells (WBC) in blood products

Leucoreduction, or post-collection processing with special filters, can lower the white blood cell (WBC) count, minimizing complications associated with transfusions. BD Leucocount™ Kit, containing BD Leucocount™ Reagent and BD Trucount™ Tubes, is designed for accurate counting of residual WBCs in leucoreduced blood products. The BD Leucocount™ PLT and RBC controls are used to monitor methods for enumeration of residual leucocytes in leucoreduced platelet and RBC products respectively.

 

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Flow Cytometry
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BD FACSLyric™ Flow Cytometry

The BD FACSLyric™ flow cytometry solution combines simplicity, speed and automation to ease workflow and improve productivity. This next-generation flow cytometer enables flow cytometry workflow standardisation and collaboration through automation and unique assay portability capabilities.

 

FACSuite™ software, will soon be IVDR compliant. It also offers assay modules for BD-IVD applications enabling automated gating for more standardised, efficient and less error-prone acquisition and analysis workflows. The BD FACSLyric™ Flow Cytometer has already been validated for use with IVD assay modules for BD OneFlow™ Reagents and lymphocyte subset identification and stem-cell enumeration. BD Biosciences is continuing to increase the portfolio of IVD assays validated with the BD FACSLyric™ Flow Cytometer.

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Automated Sample Preparation
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The BD FACSDuet™ Sample Preparation System

The BD FACSDuet™ Sample Preparation System is designed to move the pace of your lab forward. With pre-analytical automation and process standardisation, the BD FACSDuet™ Sample Preparation System drives efficiency and consistency in workflows. When physically integrated with the BD FACSLyric™ Flow Cytometer, the BD FACSDuet™ Sample Preparation System delivers front-to-end automation with walkaway capabilities.

 

With automated cocktail preparation and the possibility of using reagent vials from the major reagent manufacturers other than BD, flexibility and standardisation of protocols are greatly enhanced to satisfy many laboratory needs.

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The BD FACSDuet™ Sample Preparation System
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The BD FACS™ Lyse Wash Assistant

The BD FACS™ Lyse Wash Assistant automates sample preparation for flow cytometry applications. Equipped with patented cell wash technology, it lyses, mixes, washes and fixes samples with minimal manual intervention.

 

It enables automated batch processing of up to 40 sample tubes per run.

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The BD FACS™ Lyse Wash Assistant
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Sample to Answer Solution
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The BD FACSDuet™ Sample Preparation System and BD FACSLyric™ Flow Cytometer

The physical integration of the BD FACSDuet™ Sample Preparation System and the BD FACSLyric™ Flow Cytometer results in a front-to-end, walkaway, sample to answer solution. When not physically integrated, the data integration allows for the transfer of worklists from one or more BD FACSDuet™ Systems to one or more BD FACSLyric™ Flow Cytometers, increasing processing capabilities and flexibility of operations.

 
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Interested in solutions planned for IVDR compliance?


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After the IVDR date of application, the products indicated on this page will be made available as IVDR compliant devices and/or as IVDD compliant devices.

BD Flow Cytometers and BD FACSDuet™ Sample Preparation System are Class 1 Laser Products.

  1. van Dongen JJM, Lhermitte L, Böttcher S, et al. on behalf of the EuroFlow Consortium (EU-FP6, LSHB-CT-2006-018708). EuroFlow antibody panels for standardized n-dimensional flow cytometric immunophenotyping of normal, reactive and malignant leukocytes. Leukemia. 2012;26(9): 1908-1975. doi: 10.1038/leu.2012.120
  2. van der Velden VHJ, Flores-Montero J, Perez-Andres M, et al. Optimization and testing of dried antibody tube: The EuroFlow LST and PIDOT tubes as examples. J Immunol Methods. 2019;475:112287. doi: 10.1016/j.jim.2017.03.011
  3. Moloney E, Watson H, Barge D, et al. Efficiency and health economic evaluations of BD OneFlow™ Flow Cytometry Reagents for diagnosing chronic lymphoid leukemia. Cytometry B Clin Cytom. 2019;96(6):514-520. doi: 10.1002/cyto.b.21779

EuroFlow or any of the EuroFlow participants cannot be held liable for any claims or damages in connection with their services in the field of flow cytometry.