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FDA Clears Roche Diagnostics' Cobas e 801 System

NEW YORK (360Dx) – The US Food and Drug Administration has cleared Roche Diagnostics' Cobas e 801 immunoassay analyzer for the in vitro determination of analytes in body fluids, the agency announced recently.

The agency also cleared Roche's Elecsys TSH immunoassay for the in vitro quantitative determination of thyrotropin in human serum and plasma. TSH measurements are used for diagnosing thyroid or pituitary disorders. The assay is intended for use on the Cobas e analyzers.

The Cobas e 801 is part of the Cobas 8000 modular analyzer series from Roche and uses electrochemiluminescent technology for signal generation and measurement. According to documents filed with the FDA, the instrument can generate 300 tests per hour per module.

Earlier this month, Roche officials said that they plan to launch Cobas e 801 in the US in the third quarter. The platform is already available in countries that recognize the CE mark.

The FDA also recently cleared Roche's Elecsys Troponin T Gen 5 Stat, an immunoassay for the in vitro quantitative determination of cardiac troponin T in lithium heparin plasma. Intended for use on Cobas system analyzers, the assays can help diagnose myocardial infarction.

Additionally, FDA gave 510 (k) clearance to Danaher business Beckman Coulter's reagents for the quantitative determination of IgG immunoglobulins in human serum, plasma, and cerebrospinal fluid on the firm's AU analyzers. Measurement of IgG levels can be used in diagnosing abnormal protein metabolism and a body's inability to fight off infectious agents.

The FDA also cleared Immunostics' hema-screen ER Xcel Enhanced Readability Fecal Occult Blood Test, a rapid qualitative test for detecting occult blood in stool samples. It is intended for use in diagnosing asymptomatic gastrointestinal conditions that may "manifest themselves by the presence of occult blood in the stool," according to an FDA document. The test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in the testing of postoperative patients and newborn infants.

Meanwhile, BioMérieux received 501 (k) clearance for its Vitek 2 AST-Gram Negative Tigecycline, a quantitative test for determining antimicrobial susceptibility testing of gram-negative bacilli. It is  intended for use with the Vitek and Vitek 2 compact systems.