(36 days)
AllGrad cell separation media is intended for use in assisted reproduction techniques.
Not Found
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.
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.