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Nanochip 400 510(k)

This article was originally published in The Gray Sheet

Executive Summary

Nanogen files a 510(k) for its Cystic Fibrosis Kit and Nanochip 400 microarray system for carrier testing in adults, as an aid to newborn screening and in confirmatory diagnostic testing in newborns and children. The genetic assay uses an automated multiplexing platform that tests for 23 mutations, which account for 90% of U.S. cystic fibrosis cases. In August 2005, the firm received one of several letters from FDA to in vitro diagnostic test makers warning that its tests were "integrated" diagnostic devices that require 510(k) clearance (1"The Gray Sheet" Aug. 22, 2005, p. 9)...

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