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IND One Step hCG Pregnancy Test - Cassette Format is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are intended for professional use.

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The provided text is a 510(k) clearance letter from the FDA for a pregnancy test device. It does not contain the detailed study information or acceptance criteria that would allow me to answer your request with all the specified points.

The document primarily focuses on the regulatory clearance of the device (IND One Step hCG Pregnancy Test - Cassette Format) and its substantial equivalence to a predicate device. It briefly mentions the "Indications for Use" but does not delve into the performance studies or the specific acceptance criteria used to validate the device.

Therefore, I cannot provide a detailed answer to your request based solely on the provided text.

To answer your request, you would need a document that includes performance study summaries, such as:

• Clinical Study Report: This would detail the methodology, sample sizes, ground truth establishment, expert qualifications, and results.
• Validation Report: Similar to a clinical study report, focusing on the technical validation of the device's performance characteristics.
• Predicate Device Performance Data: Sometimes, the 510(k) summary might compare the new device's intended performance to a predicate device, but it still often lacks the granular detail of specific acceptance criteria.

Without such a document, I am unable to fill in the table or address points 1-9 of your request.

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