INITO FERTILITY MONITOR

Description of Event or Problem

FOR SOME TIME, I'VE BEEN USING A FERTILITY MONITOR AND APP CALLED INITO. IT CLAIMS TO HAVE FDA APPROVAL, BUT I CANNOT FIND IT IF I SEARCH ON THE FDA WEBSITE (HTTPS://ECONOMICTIMES.INDIATIMES.COM/TECH/STARTUPS/CITY-STARTUP-DEVELOPS-FERTILITYMONITOR- THAT-ENABLES-PHONES-TO-PERFORM-TESTS-AT-HOME/ARTICLESHOW/78994525.CMS). I REALIZE THAT URINE TESTS CAN BE LESS ACCURATE THAN BLOODWORK, AND THE APP MENTIONS A 15% DEVIATION IS POSSIBLE FROM LAB TESTS. BUT THE COMPANY ALSO CLAIMS THAT IT IS ABLE TO PERFORM LAB-GRADE HORMONAL TEST THAT ARE QUANTITATIVE, AND SO FOR AT LEAST A YEAR, I'VE BEEN TRYING TO GET AN IDEA OF MY HORMONAL HEALTH USING THE APP. I'VE ALSO DONE DOCTOR ORDERED BLOOD WORK IF AND WHEN I COULD. AS FAR AS I CAN REMEMBER, I HAVEN'T SEEN A HUGE DISCREPANCY BETWEEN THOSE TEST RESULTS AND THOSE I'VE SEEN ON THE APP. I'VE PURPOSELY TESTED URINE ON THE DAY THAT I WOULD HAVE BLOODWORK AND I CANNOT REMEMBER BEING SURPRISED BY A HUGE DIFFERENCE IN RESULTS, UNTIL THIS SATURDAY DECEMBER 14, 2022. THE DAY BEFORE THAT MY APP MEASURED E3G LEVELS OF 113.2 AND FSH LEVELS OF 5.2 (AMONG OTHER HORMONES) BLOODWORK FROM THE DAY AFTER HAD E2 LEVELS OF LESS THAN 15 PG/ML AND FSH OF 60, WHICH IS MENOPAUSAL. (I AM 36). E3G LEVELS SHOULD CORRELATE WITH E2 LEVELS, WHICH IN THIS TESTING INSTANCE IT DID NOT. AND THE QUANTITATIVE FSH LEVEL IS QUITE OBVIOUSLY NOWHERE NEAR CORRECT. I HAVE IRREGULAR PERIODS SO I DON'T RELY ON THE APP TO TELL ME MY FERTILE DAYS CORRECTLY, BUT ITS PROMISE OF ACCURATE QUANTITATIVE TESTING IS FULLY UNTRUSTWORTHY IF THIS IS HOW FAR THE TEST RESULTS ARE FROM LAB BLOOD WORK. MY MAIN QUESTION IS: IS THIS DEVICE ACTUALLY FDA APPROVED? AND WHAT CAN BE DONE TO MAKE SURE THAT THEY ARE NOT DECEIVING CONSUMERS IN BELIEVING THE APP'S HORMONE READINGS ARE ACCURATE. THE DAY AFTER MY BLOODWORK I DID ANOTHER URINE TEST WHICH GAVE ME 109.5 E3G AND 6.2 FSH. THERE IS NO WAY THIS IS ACCURATE AS THOSE HORMONES CANNOT FLUCTUATE TO THAT EXTENT IN LESS THAN 24 HRS. I WOULD LIKE TO FILE A COMPLAINT BECAUSE I HAVE BEEN COMMUNICATING WITH THE COMPANY WITH THESE AND OTHER PRIOR CONCERNS WITH THE TEST STRIPS AND THE APP'S INTERPRETATIONS. I'D BE HAPPY TO PROVIDE THOSE EMAILS, WHICH ILLUSTRATE HOW THEY WAVE AWAY THESE CONCERNS WITH ANSWERS THAT MAKE NO SENSE AND, IN MY EYES, POINT TO THE INABILITY OF THE TESTS TO BE REPRODUCIBLY ACCURATE. DO LET ME KNOW WHAT ELSE I COULD PROVIDE TO BE OF HELP. THE COMPANY IS: CENTUM ELECTRONICS LTD, BASED IN INDIA. GIVING WOMEN INACCURATE RESULTS ABOUT FERTILITY HORMONES IS NOT ONLY EMOTIONALLY DAMAGING, BUT ALLOWS SERIOUS ISSUES TO GO UNNOTICED. THANK YOU, SISKA LYSSENS.