Maine Standards receives FDA clearance test kit

Maine Standards Company, LLC, announced that it has received the U.S. Food and Drug Administration’s 510(k) clearance of its VALIDATE® VIT D calibration verification / linearity test kit. The VALIDATE® VIT D contains 25-hydroxyvitamin D in a human serum base matrix. Clearance of this product will allow clinical laboratories to use it for their required vitamin D calibration verification / linearity testing, maximizing the reportable range while minimizing manual dilutions.

There is an increasing need for a calibration verification / linearity product as the number of clinical laboratory instrument manufacturers bring their vitamin D tests to market. The new calibration verification / linearity kit will provide laboratories with confidence in their testing results. The addition of vitamin D to the Maine Standards Company portfolio of products demonstrates the company’s continued commitment to manufacture calibration verification / linearity products to meet customers’ needs.

VALIDATE® VIT D is designed for use on all major manufacturers’ clinical laboratory instruments. Each test kit contains five levels prepared using the Clinical Laboratory Standards Institute’s recommended “equal delta” method for linearity testing. The test kits are liquid and ready to use. Simply add the product from the dropper bottle directly into a sample cup and run as a patient sample in duplicate or triplicate.

Maine Standards Company’s MSDRx® data reduction software is available at no charge for real-time data analysis or, in the United States, a laboratory can send their data to Maine Standards Company where technical specialists will complete the data analysis and return a report within five business days.