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# FDA Clears Irvine Scientific Expanded Use for Fertility Kit
- URL: https://www.fdaweb.com/fda-clears-irvine-scientific-expanded-use-for-fertility-kit/
- Published: 2016-05-09T12:00:00.000Z
- Updated: 2026-09-14T21:00:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135601

> FDA has cleared an Irvine Scientific 510(k) for expanded use of its Vit Kit vitrification media to include human oocytes. The company says it is the first to obtain such a clearance. Its Vit Kit-Freeze and Vit Kit-Thaw are now intended for use with oocytes, pronuclear zygotes through day three cleavage-stage embryos and blastocyst-stage embryos. Vitrification is a cryopreservation technique that Irvine Scientific says provides “excellent survivability of embryos and oocytes through dehydration and ultra-rapid cooling. This process eliminates the concerns of damaging ice-crystal formation associated with traditional slow freezing. The ability to offer an FDA-cleared vitrification media for oocytes will enhance the ability of fertility clinics to preserve women’s fertility through oocyte freezing.”