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Refrigeration Medium (Test Yolk Buffer) Cat. #9972

FDA 510(k)

Class II (US FDA 510(k))

510(k) K872203

by Irvine Scientific

Identifiers

510(k) Number
K872203 FDA 510(k)
FDA Product Code
HDR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.5250 FDA 510(k)
Regulation Number
884.5250 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Refrigeration Medium (Test Yolk Buffer), classified as a Cap, Cervical under FDA nomenclature. It is designed to protect biological samples during refrigerated storage, maintaining viability for assisted reproductive technology (ART) applications such as intrauterine insemination, in vitro fertilization (IVF), and intracytoplasmic sperm injection.

The medium is supplied as a sterile, single-use solution intended for clinical obstetrics and gynecology settings. It is regulated under FDA 510(k) clearance (K872203) and falls under Class II medical devices (HDR product code). Storage and handling must comply with standard laboratory protocols for cryopreservation support media, ensuring sterility and sample integrity.

Frequently asked questions

What clinical procedures is this refrigeration medium specifically intended to support during storage of biological samples?

This refrigeration medium (Test Yolk Buffer) is designed to protect biological samples during refrigerated storage for assisted reproductive technology (ART) procedures, including intrauterine insemination, in vitro fertilization (IVF), and intracytoplasmic sperm injection. Its role is to maintain sample viability under controlled conditions, ensuring integrity for these fertility treatments.

Is this product single-use, and if so, how does that impact its handling and storage requirements?

Yes, this refrigeration medium is supplied as a sterile, single-use solution. Because it is intended for one-time use, proper handling and storage must follow standard laboratory protocols for cryopreservation support media to preserve sterility and prevent contamination. Once opened or exposed, it should not be reused to avoid compromising sample integrity.

What regulatory pathway does this device follow, and how does that affect its use in clinical settings?

This refrigeration medium is regulated under the FDA’s 510(k) clearance pathway (K872203) and is classified as a Class II medical device under the HDR product code. Its clearance indicates it has been deemed substantially equivalent to a legally marketed predicate device, meaning it meets FDA standards for safety and effectiveness in obstetrics/gynecology settings. Clinicians can rely on this classification to confirm its compliance with regulatory requirements for use in ART procedures.

Are there specific storage conditions or shelf-life considerations for this product?

While the exact shelf-life isn’t detailed here, the product is described as sterile and intended for clinical use in obstetrics/gynecology settings. Storage must adhere to standard laboratory protocols for cryopreservation support media to maintain sterility and sample viability. Always check the manufacturer’s labeling for expiration dates and storage instructions, as improper handling could compromise its effectiveness.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cat. #9972 Refrigeration Medium (Test Yolk Buffer), Cat. #9972 Refrigeration Medium (test Yolk Buffer) 510 (k) FDA ..., Irvine Scientific FDA 510 (k) Products (1982-2016), Freezing Medium - Test Yolk Buffer (Tyb) With Glycerol, Refrigeration ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Irvine Scientific

Sources (1)

  • FDA 510(k) K872203 24 fields · synced Sep 19, 2026