(156 days)
Phosphate Buffered Saline (PBS) and Phosphate Buffered Saline, with calcium, magnesium, glucose, pyruvate and phenol red are for in vitro procedures involving the manipulations of gametes and embryos such as oocyte retrieval or embryo transfer, gamete washing, or micromanipulation. They may also be used for cryopreservation of qametes and embryos after the addition of appropriate cryopreservation agent(s).
Phosphate Buffered Saline (PBS) and PBS with calcium, magnesium, glucose, pyruvate and phenol red Medium
This document is a 510(k) clearance letter from the FDA for Phosphate Buffered Saline (PBS) and PBS with additional components, intended for use in in-vitro procedures involving gametes and embryos.
The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
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§ 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.