VITROS(R) 3600 Immunodiagnostic System for Laboratory Diagnostics Receives 510(k) Clearance from the FDA

Wednesday, December 24, 2008 General News
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- High-Volume System Combines Accuracy and Efficiency with Broad Menu of Routine and Infectious Disease Immunoassays -

RARITAN, N.J., Dec. 23 /PRNewswire/ -- Ortho Clinical Diagnostics today announced 510(k) clearance from the United States Food and Drug Administration (U.S. FDA) for its VITROS(R) 3600 Immunodiagnostic System. This new high-capacity immunoassay system provides laboratories with a truly innovative solution to address their quality, labor and cost challenges. The VITROS(R) 3600 delivers high-quality and dependable results by offering a broad and comprehensive immunoassay menu based on world-class VITROS(R) technologies. This is the second clearance for Ortho Clinical Diagnostics this quarter, following 510(k) clearance of the VITROS(R) 5600 Integrated System in October. Both systems are now commercially available in the United States.

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The VITROS(R) 3600 Immunodiagnostic System combines three proven VITROS(R) technologies into a single system, designed to consistently produce highly accurate test results:

Additionally, the processing speed, on-board reagent capacities and uninterrupted workflow advantages of the system allow laboratories to address peak workloads and decrease turnaround times.

"One of the key challenges faced by diagnostic laboratories today is the need to decrease the turnaround time required to provide accurate and reliable test results to clinicians. The intelligent sample management capabilities of the VITROS(R) 3600 Immunodiagnostic System allow users to increase productivity while maintaining high-quality test results," said Denise Uettwiller-Geiger, Ph.D., Administrative Director and Director of Clinical Research at John T. Mather Memorial Hospital in Port Jefferson, N.Y. "The large capacity of 31 reagent packs and the ability to change reagents and consumables, as well as offload waste while the VITROS(R) 3600 Immunodiagnostic System is operating, provides uninterrupted workflow to ensure we can keep up with testing demands." Dr. Uettwiller-Geiger is a principal investigator for the VITROS(R) 3600 Immunodiagnostic System.

The VITROS(R) 3600 Immunodiagnostic System can be easily integrated with the enGen(TM) Laboratory Automation System and other VITROS(R) Systems, such as the VITROS(R) 5,1 FS Chemistry System, allowing users to easily expand or change modules and interfaces as their needs change.

"The introduction of the VITROS(R) 3600 Immunodiagnostic System continues our commitment to go beyond merely improving existing technologies to help clinical laboratories meet their challenges," said Ortho Clinical Diagnostics Worldwide Commercial President Mark Straley. "We built this new high-capacity system based on a foundation of proven VITROS(R) technologies to give our customers the ability to consistently produce highly accurate test results for high-volume routine immunoassays, such as cardiology, thyroid and endocrinology, and infectious disease immunoassays, such as HIV and hepatitis."

About the VITROS(R) 3600 Immunodiagnostic System

Designed with the input and feedback from a diverse group of laboratories around the world, the VITROS(R) 3600 Immunodiagnostic System complements and extends the capabilities of the VITROS(R) family of instruments. The VITROS(R) 3600 Immunodiagnostic System will use the same reagents as other VITROS(R) Systems, thereby maintaining the same degree of accuracy and efficiency. The single-use tips on the system eliminate sample and reagent carryover and automatically detect clots and bubbles to avoid reporting erroneous results.

The broad menu of 47* immunoassays covers disease states including: cardiology, oncology, endocrinology, infectious disease, thyroid, metabolic conditions, and anemia. Among these world-class assays is the VITROS(R) Troponin I ES Assay, which features improved sensitivity and more reliable information for patients with acute coronary syndrome; and the VITROS(R) Anti-HCV Assay, which features improved sensitivity to test for IgG antibody to hepatitis C virus. In the future, Ortho Clinical Diagnostics plans to seek U.S. regulatory approval for the first fully random-access, automated HIV assay (VITROS(R) Anti-HIV 1+2 Assay) for the VITROS(R) 3600 Immunodiagnostic System. This assay was originally approved by the FDA in March 2008 on the VITROS(R) ECiQ Immunodiagnostic System.

The integrated system incorporates proven VITROS(R) technologies into one of the easiest-to-use systems on the market. The VITROS(R) 3600 Immunodiagnostic System does not have any water or drainage requirements, minimizing waste and allowing flexibility in instrument location. It is designed to meet the high-volume testing needs of customers managing skilled labor shortages and budget restrictions.

About Ortho Clinical Diagnostics

Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company, delivers the high-quality in-vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to ensure every patient receives blood that's safe, the right type, and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies, and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit

* Menu availability is subject to local regulatory approvals.

-- MicroWell Technology with enhanced chemiluminescence enables exceptional assay performance with small sample volume requirements across a broad range of diseases. -- MicroSensor Technology automatically performs sample quality indices checks for the first time ever on an immunoassay system. This capability reduces the time, labor and error potential of manual interpretation. -- Intellicheck(R) Technology verifies analytical performance and reduces error potential by providing real-time operator notification and tracking.

SOURCE Ortho Clinical Diagnostics

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