Description of Event or Problem · 0
I PURCHASED A URINE TEST STRIP PRODUCT FROM AMAZON (URS 9-IN-1 TEST STRIP MADE BY A COMPANY CALLED PALINOIA; LINK: HTTPS://WWW.AMAZON.COM/PARAMETERS-TESTING-PROTEIN-LEUKOCYTES-NITRITE/PRODUCTREVIEWS/B0B6GXN7VP/REF=CM_CR_DP_D_SHOW_ALL_BTM?IE=UTF8&REVIEWERTYPE=ALL_REVIEWS) BECAUSE I HAVE DIABETES, I NOTICED SOME ABNORMALITIES IN MY URINE, AND I WANTED TO SEE IF THERE ARE ISSUES WORTH FOLLOWING UP WITH MY DOCTOR. I PURCHASED THE PRODUCT UNDER THE ASSUMPTION THAT IT WAS AN FDA-CLEARED OVER THE COUNTER DIAGNOSTIC TEST BECAUSE IT HAS AN IVD (IN VITRO DIAGNOSTICS) MARKING ON THE PACKAGE. THE INSTRUCTIONS ARE CONFUSING AND THERE IS NO DESCRIPTION OF WHAT THE TEST RESULTS MEAN OR INDICATE. FOR EXAMPLE, THERE IS NO EXPLANATION AS TO WHAT THE "KIDNEY FUNCTION" TEST SQUARE IS ASSESSING OR HOW TO INTERPRET THE RESULTS. I ASKED A FAMILY MEMBER WITH REGULATORY EXPERIENCE FOR HELP INTERPRETING THE RESULTS AND HE WAS UNABLE TO MAKE SENSE OF IT EITHER. MY FAMILY MEMBER TRIED TO FIND THE PUBLIC FACING DECISION SUMMARY DOCUMENT AND WAS UNABLE TO FIND IT. HE ALSO SEARCHED THE REGISTRATION AND LISTING DATABASE AS WELL AS THE 510(K), DE NOVO, AND PMA DATABASES AND WAS UNABLE TO FIND ANY RECORDS FOR THE COMPANY ("PALINOIA" OR "CENTEROBLIVION"). I AM CONCERNED THAT THIS COMPANY IS ILLEGALLY MARKETING THIS TEST WITH AN IVD LABEL AND, FURTHERMORE, I'M ANNOYED THAT I WASTED MONEY ON A PRODUCT THAT PROVIDES A RESULTS THAT I CANNOT INTERPRET. I'M FILING THIS COMPLAINT SO THAT FDA IS AWARE OF THIS FIRM AND PRODUCT. THE TEST STRIP SEEMS TO BE DESIGNED TO MEASURE NINE DIFFERENT ANALYTES. I PROVIDED RESULTS FROM THE "KIDNEY FUNCTION" TEST. IF THIS TEST STRIP IS FDA CLEARED, THERE ARE NO INSTRUCTIONS OR EXPLANATION OF THE TEST RESULTS LIKE I WOULD HAVE EXPECTED (FOR EXAMPLE, THE INSTRUCTIONS THAT COME WITH OVER-THE-COUNTER COVID-19 TESTS).