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The CLEARVIEW EASY HCG Pregnancy Test, an in vitro diagnostic device, is intended to be used for the early detection of pregnancy via a urine test. The CLEARVIEW EASY HCG Test is a qualitative test which detects the hormone human chorionic gonadotrophin (hCG) in urine. It is for professional use and for use in the physician's office.

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The provided text is a 510(k) clearance letter from the FDA for the "Clearview Easy HCG Pregnancy Test". It confirms the device's substantial equivalence to a legally marketed predicate device but does not contain any information regarding acceptance criteria, device performance data, study design, ground truth establishment, or sample sizes used in any studies.

The letter primarily focuses on:

• Confirming the 510(k) submission (K993703) and the device's trade name.
• Stating the device's regulatory class (II) and product code (JHI).
• Declaring the device substantially equivalent to a predicate.
• Outlining the general controls and potential additional controls (for Class II/III devices) under the Federal Food, Drug, and Cosmetic Act.
• Mentioning CLIA complexity categorization.
• Providing contact information for regulatory inquiries.
• Including an "INDICATIONS FOR USE STATEMENT" which specifies the device's intended use: "early detection of pregnancy via a urine test... a qualitative test which detects the hormone human chorionic gonadotrophin (hCG) in urine. It is for professional use and for use in the physician's office."

Therefore, I cannot provide the requested information. The document primarily serves as a regulatory approval notice, not a detailed study report.

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