Affymetrix and Roche Diagnostics have separately filed for de novo 510(k) approval from the US Food and Drug Administration of their microarray-based diagnostic for drug metabolism, the companies confirmed last week for BioArray News’ sister publication GenomeWeb News.

Affy filed for clearance of its GeneChip 3000Dx reader, while Roche is seeking approval for its CYP450 AmpliChip. Both attained a Conformité Européenne Mark in early September for the microarray — the first product developed under their collaboration inked in Jan. 2003.