FDA Clears Commercial Release of Access TSH (3rd IS) Assay for Beckman Coulter Immunoassay Systems


BREA, Calif. — (Oct. 17, 2016) — Beckman Coulter Diagnostics is pleased to announce FDA clearance and the commercial release of its new Access TSH (3rd IS) assay for use with the Access Family of Immunoassay Systems. This new assay is the next generation of the Access HYPERsensitive hTSH and Access Fast hTSH assays for the quantitative determination of human thyroid stimulating hormone (TSH, thyrotropin). The Access TSH (3rd IS) assay is an important enhancement to Beckman Coulter's thyroid assay menu, which includes a full panel of thyroid tests that aid in the diagnosis of thyroid function.

The new Access TSH (3rd IS) assay offers laboratories:

  • Confidence in patient results through standardization to the World Health Organization 3rd International Standard (3rd IS) for human TSH (IRP 81/565)
  • Maximized laboratory workflow with a larger reagent pack size (100 tests/pack, 200 tests/kit) that improves laboratory efficiency
  • Reliable and accurate results with an assay range that supports measuring patient samples as low as 0.01 µIU/mL

"FDA clearance and commercialization of our new Access TSH (3rd IS) assay offers laboratories a sensitive and accurate tool for diagnosis and monitoring of thyroid disease. A core assay in the thyroid panel, it also empowers laboratories to provide faster, more reliable diagnosis of an underactive or overactive thyroid," said John Blackwood, senior vice president, Chemistry and Immunoassay business unit, Beckman Coulter Diagnostics. "The newly designed assay improves time to first result while maintaining assay throughput."

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay designed for use in Access immunoassay systems to accurately provide quantitative determination of human thyroid-stimulating hormone levels in human serum and plasma. This assay is capable of providing third-generation TSH results.1, 2

Additionally, the Access TSH (3rd IS) assay was developed to reduce non-specific interferences and to deliver robust lot-to-lot performance for reproducible results. The current standards of care require laboratories to use third-generation TSH assays, like the Access TSH (3rd IS) assay, as this level of sensitivity is necessary for detecting differing degrees of TSH suppression.       

About Beckman Coulter
Beckman Coulter Diagnostics develops clinical diagnostic products that help advance and optimize the clinical laboratory. Beckman Coulter's instruments, systems and tests help streamline processes to enhance efficiency, reduce costs and speed the delivery of results. For 80 years, Beckman Coulter has been a global. leader devoted to providing solutions to laboratories of all sizes, offering a broad portfolio of chemistry, immunoassay, hematology, urinalysis, microbiology, automation and information systems. Beckman Coulter is dedicated to advancing healthcare for every person and moving science, innovation and the lab forward. For more information, visit www.beckmancoulter.com.

1. Instructions for Use B83033 D, Access TSH (3rd IS), Beckman Coulter, Inc.
2. Instructions for Use B77707 C, Access TSH (3rd IS) Calibrators, Beckman Coulter, Inc.

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