One Step HCG Urine Pregnancy Test

This device is designed for use in both clinical settings and at home, making it versatile for point-of-care testing. It is supplied as a single-use, non-sterile strip format, meaning each test is individually packaged and intended for one-time use only. This format ensures convenience for users while maintaining simplicity in administration.

No, this pregnancy test is explicitly designed for single-use only, meaning each test strip must be discarded after one use. Since it is non-sterile, proper storage and handling are critical to avoid contamination. The manufacturer’s guidelines for in vitro diagnostics should be followed, which typically include keeping the test in a dry, sealed environment away from direct sunlight or extreme temperatures until use.

This device has been authorized through FDA 510(k) clearance and complies with In Vitro Diagnostic Device (IVDD) regulations. The clearance was granted under the Clinical Chemistry advisory committee, with a decision confirming it as substantially equivalent to a predicate device. This implies the device has undergone rigorous review for accuracy, performance, and safety, ensuring it meets established standards for detecting human chorionic gonadotropin (hCG) in urine.

The provided data does not specify multiple sizes or models for this device—it is described as a single-format strip test. All versions appear to follow the same qualitative detection method for hCG in urine, with no variations in design or functionality indicated. If additional formats exist, they would not be reflected in the available documentation.

While the device itself is non-sterile, it should be stored according to standard in vitro diagnostic guidelines to maintain its integrity. This typically means keeping it in a cool, dry place away from direct sunlight or extreme temperatures until use. Since it is a single-use strip, no special handling beyond following the manufacturer’s instructions is required prior to administration.