(39 days)
AllGrad 45 and 90 cell separation media by is intended for use in assisted reproduction techniques.
ALLGrad™ Cell Separation Media 45% and 90% Density Gradient Solution
This is a letter to the submitter of a 510(k) premarket notification and does not contain the requested information about acceptance criteria or study details. The letter grants clearance for the device "AllGrad™ 45 and 90 cell separation media" for use in assisted reproduction techniques based on substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested table or study details based on the provided text.
§ 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.