TCI Group
This article was originally published in The Gray Sheet
Executive Summary
Self-administered TCI Ovulation Tester receives FDA over-the-counter clearance for detecting the most fertile days of a woman's menstrual cycle by the direct visualization of characteristic peri-ovulatory ferning patterns seen in dried saliva. In clinical trials, saliva ferning on a glass slide could be identified 93% of the time by untrained women using the device's mini-microscope. The test, which produces results in 10 minutes, demonstrated substantial equivalence to Quidel's urine sample-based Conceive ovulation predictor...