Carolina Liquid Chemistries receives 510(k) clearance for analyzer, “Moderate Complexity” categorization for Vitamin D test

May 30, 2014

Carolina Liquid Chemistries Corp. has received 510(k) clearance from the Food and Drug Administration (FDA) to market its new CLC6410 chemistry analyzer. The CLC6410 is a modular chemistry analyzer designed to meet the high-volume testing needs of large hospitals and clinical reference laboratories. The throughput of a single module is up to 1600 tests/hour, while four modules can be joined to achieve 6400 tests/hour. The new analyzer also features other technological advances that save water and energy while automating many quality control procedures.

The company has also announced that its “Vitamin D-direct” test has received a “Moderate Complexity” categorization from the FDA. Vitamin D-direct is run on the company’s CLC720 chemistry analyzer, which can run up to 400 Vitamin D tests per hour and can be run in random access mode with other chemistry tests, eliminating the need for batch testing. The direct Vitamin D test is a homogenous immunoassay which measures the true total 25-Hydroxy Vitamin D (sum of both D3 + D2). According to company representatives, it introduces a number of enhancements, including a wide dynamic range with improved precision, the elimination of time-consuming washing steps, and the elimination of inaccurate results caused by “matrix effects.” The test is traceable to the newest standard reference material from the National Institute of Standards and Technology (NIST).

Carolina Liquid Chemistries is an ISO-certified and FDA-regulated manufacturer of chemistry systems that offers a broad range of chemistry analyzers, from moderate-throughput benchtop analyzers to ultra high-speed floor models, along with the reagents and service to support the instrumentation. Learn more about products offered by this manufacturer.

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