March 2010 Clinical Laboratory News: News from the FDA

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March 2010: Volume 36, Number 3

Abaxis Receives FDA 510(k) Clearance for New CRP Test

Abaxis announced that FDA granted 510(k) marketing clearance for its new C-reactive protein (CRP) assay on the Piccolo Xpress point-of-care analyzer. The assay runs in less than 12 minutes and is suitable for detecting many types of conditions, including infections, inflammatory diseases, tissue injury, and some neoplastic processes. The test initially will be available to the U.S. market on the acute care panel MetLyte Plus CRP.

ARK Diagnostics Zonisamide Assay Cleared

The ARK Zonisamide Assay has received FDA 510(k) clearance. Manufactured by ARK Diagnostics, the assay is intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers. Zonisamide concentrations are used to aid in the treatment of patients taking zonisamide, an anticonvulsant used to treat seizures.

FDA Clears Influenza A/B Virus ID Kit

Diagnostic Hybrids announced that FDA 510(k) clearance was granted for its D3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit. The kit identifies influenza A and B from a patient specimen in less than 30 minutes. D3 FastPoint incorporates the same proprietary monoclonal antibodies used in other respiratory products by Diagnostic Hybrids. The kit also features the same fluorescent labeling technologies used in the company’s D3 Ultra and D3 Duet products and L-DFA technology that allows for the simultaneous detection of two respiratory viruses on a single slide. The new kit is the second product in Diagnostic Hybrids’ D3 FastPoint L-DFA product line.

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