Lyophilized Early Cleavage Medium Kit

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Lyophilized Early Cleavage Medium (Ecm) Kit

510(k) Number

K072607 ↗

FDA Product Code

MQL

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Irvine Scientific Sales Co., Inc. →

• What is the Lyophilized Early Cleavage Medium (ECM) Kit specifically designed to support in clinical settings?

  The Lyophilized Early Cleavage Medium (ECM) Kit is designed to support the in vitro growth of embryos during the early cleavage stage, up to three days post-fertilization. It provides essential salts and nutrients in a stable, lyophilized powder form to maintain optimal conditions for embryo development in clinical embryology laboratories.

• How is the Lyophilized Early Cleavage Medium (ECM) Kit supplied, and what preparation is required before use?

  The kit is supplied as a lyophilized powder, meaning it comes in a dried form that requires reconstitution with a compatible liquid (such as sterile water or another specified solvent) before use. This ensures the medium remains stable during storage and ready for immediate application in embryo culture.

• Is the Lyophilized Early Cleavage Medium (ECM) Kit intended for single-use or can it be reused?

  The kit is intended for single-use in clinical settings. Since it is a lyophilized powder designed for embryo culture, it should not be reused after reconstitution to maintain sterility and prevent contamination, which could compromise embryo viability.

• What regulatory pathway was followed for FDA clearance of the Lyophilized Early Cleavage Medium (ECM) Kit?

  The Lyophilized Early Cleavage Medium (ECM) Kit received FDA clearance through a 510(k) submission, classified under the Obstetrics/Gynecology advisory committee. It was determined to be substantially equivalent to a predicate device and adheres to regulatory standards outlined in 21 CFR 884.6180, confirming its compliance as a Class II medical device.

• How should the Lyophilized Early Cleavage Medium (ECM) Kit be stored, and are there any special handling instructions?

  While the data does not specify exact storage conditions, lyophilized products like this kit typically require dry, refrigerated storage (e.g., 2–8°C) to preserve stability and sterility. Always follow the manufacturer’s instructions for reconstitution and handling to ensure proper functionality and safety in clinical use.