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AllGrad cell separation media is intended for use in assisted reproduction techniques.

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I am sorry but this document does not contain the information you are looking for. This document is a 510(k) premarket notification decision letter from the FDA to International, Inc. regarding their device, Allgrad and Allgrad 100. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The letter outlines regulatory requirements and contact information but does not provide details about acceptance criteria, specific device performance studies, sample sizes, expert qualifications, adjudication methods, or groundbreaking truth establishment. These types of details are typically found within the actual 510(k) submission document itself, not in the FDA's decision letter.

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