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VeriClear™ Digital Early Result Pregnancy Test is a rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

The VeriClear™ hCG Early Result Pregnancy Test utilize the identical immunochemical principles for the detection of hCG in the urine as in K172257. It is a device intended for use by the lay user in the early detection of pregnancy by way of a series of immunochromatographic assay using colloidal gold as a direct label. The subject 510(k) device differs in which it provides a digital display of the test result for the consumer to read in place of the colored lines of the above referenced analog device. The VeriClear™ Digital Early Result Pregnancy Test device incorporates electronic and optical components along with a microprocessor and specific algorithms into the plastic housing. VeriClear™ Digital Early Result Pregnancy Test is capable of correctly determining and interpreting the test results correctly, and shows the results as "YES+" (Pregnancy), "NO-" (Non-pregnancy) or "?" (Error) on a display. The VeriClear™ Digital Early Result Pregnancy Test is powered by battery and the testing results will be displayed on the screen until the battery is used up. All components are integrated and unitized into the plastic housing.

TrueDx™ hCG Early Result Pregnancy Test (Midstream & Cassette Formatographic immunoassay for qualitative detection of human chorionic (hCG) in urine, as an in aid in early detection of pregnancy, in some case as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. VeriClear™ Early Result Pregnancy Test (Midstream & Cassette Formatographic immunoassay for qualitative detection of human chorionic (hCG) in urine, as an in aid in early detection of pregnancy, in some case as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

TrueDX™ hCG Early Result Pregnancy Test is designed to be tested in midstream and cassette mode. Each of the devices (Cassette and Midstream), contains a pouch with the test and instructions for use. The cassette and midstream nitrocellulose test strips are contained in a plastic housing. The cassette test also contains a dropper. TrueDX™ hCG Early Result Pregnancy Test is a qualitative lateral flow immunoassay for the detection of hCG. The device comes in two formats: Cassette and Midstream. Each device includes a pouch with the all components to perform the test, instruction for use and a desiccant package to control the moisture during the storage of the test kit. The cassette and midstream nitrocellulose test strips are mounted in a plastic housing. The cassette test, which is designed to be used as prescription use contains a dropper pipette. The VeriClear™ Early Result Pregnancy Test and TrueDX™ hCG Early Result Pregnancy Test are the same devices, except the device names and intended use population.