FDA Denies Biorex 510(k) Exemption Petition

FDA has denied a 1/7 petition from Biorex Labs seeking exemption from the premarket notification requirements for its copper reduction tablet test that measures glucose in urine. The denial letter says that such tests are used in diagnosing and treating carbohydrate metabolism disorders and says that such tests require 510(k) premarket notification.

The agency says the petition is denied because it has determined that premarket notification is necessary to provide a reasonable assurance of the copper reduction tablet test’s safety and effectiveness. “Your petition has not established that the ‘simplicity’ of this device and the availability of quality control materials are sufficient to provide a reasonable assurance of the safety and effectiveness of this device,” the FDA letter says. “Furthermore, FDA does not agree that the use of the device is well established without any reports of patient or user injury.”