Metrika to submit POC osteoporosis analyzer 510(k) by year end under deal with Ostex.
This article was originally published in The Gray Sheet
Executive Summary
METRIKA LABS DIRECT RESPONSE POC OSTEOPOROSIS TEST 510(k) SUBMISSION is planned for late 1997, the Sunnyvale, California firm says. The one-step point-of-care test is being developed by Metrika under an agreement with Ostex, and detects the cross-linked N-Terminal Telopeptides (NTx) marker owned by Ostex. Ostex will market Direct Response in the U.S. upon clearance by FDA.