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The FIRST RESPONSE® One-Step Digital Pregnancy Test is an in vitro diagnostic test device that incorporates a digital read out of the test result for the early detection of pregnancy (hCG in urine) by the lay user prior to the expected menses

The FIRST RESPONSE® One-Step Digital Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a device intended for use by the lay user in the early detection of pregnancy by the detection of hCG, a placental hormone in urine. The FIRST RESPONSE® One-Step Digital Pregnancy Test labeling provides for the use of the test as early as three (3) days before the expected period. [Refer to K992232.] The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions via component reagents that are striped onto a chromatographic strip contained within a plastic housing, which is integral with the digital component that reads and displays. the result of the immunochemical reaction on the Display Screen of the device housing, as opposed to an analog display of the predicate device. The immunochemical reagents that are striped onto a chromatographic strip are unchanged from the predicate FIRST RESPONSE® One-Step Pregnancy Test. Following the instructions for use provided with the device, the test is performed by placing the Absorbent Tip into the urine stream (alternatively a cup of urine may be used) for 5 seconds, then allowing the test to continue for 3 minutes. During this time, a blinking clock icon appears on the Display Screen of the device housing to indicate that the test is working. After the elapse of 3 minutes, a digital display of the result appears on the Display Screen: a "YES+" test result indicates that the pregnancy hormone (hCG) was detected (pregnant); a "-- NO" test result indicates that the pregnancy hormone (hCG) was not detected (not pregnant). A " ? " (question mark) appears when a test error has occurred.

The TROJAN® PASSION BERRY™ Gel patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. The TROJAN® PASSION BERRY™ Gel is principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. The TROJAN® PASSION BERRY™ Gel may be used with condoms.

The TROJAN® PASSION BERRYTM Gel personal lubricant is formulated as a clear, high viscosity gel with a pink color and lubricant is lonnalise as agrance and packaged in a clear plastic 2.5 oz. tube.

The TROJAN® CRYSTAL CLEAR Liquid is principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. The TROJAN® CRYSTAL CLEAR Liquid may be used with condoms. The TROJAN CRYSTAL CLEAR Liquid patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

The TROJAN® CRYSTAL CLEAR Liquid personal lubricant is a water-soluble, greaseless, unscented, clear, colorless liquid, 2.1 oz of which is packaged in a clear plastic bottle.