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T Cell Diagnostics

This article was originally published in The Gray Sheet

Executive Summary

Will respond "within 30 days" to an FDA request for additional information on the firm's 510(k) for its TRAx CD4 cell enumeration test kit, the firm says Dec. 7. The requested data includes: package insert modifications, "precision data on kit components," additional explanations "of some data points," and "new presentation formats" for some data. T Cell says the information is "available from already completed clinical trials" and that "no data requiring new clinical trials" has been requested. The Needham, Massachusetts-based firm originally submitted the 510(k) application in October 1992 ("The Gray Sheet" Oct. 26, 1992, In Brief)
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