CRYOcheck Factor VIII Deficient Plasma with VWF

510(k) Number

K222831 ↗

FDA Product Code

GJT

FDA applicant

Precision Biologic, Inc.

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Precision Biologic Inc →

• What is CRYOcheck Factor VIII Deficient Plasma with VWF used for?

  This reagent is designed as a deficient substrate for clot-based Factor VIII activity assays using the one-stage activated partial thromboplastin time (APTT) method. It helps clinicians measure functional and antigenic levels of Factor VIII and von Willebrand Factor (vWF) in patients with Factor VIII deficiencies, such as hemophilia A. The immunodepleted, platelet-poor plasma ensures reliable baseline testing by providing minimal residual Factor VIII activity (<1%) while maintaining added vWF for accurate diagnostic results.

• How is the CRYOcheck Factor VIII Deficient Plasma with VWF supplied and stored?

  The reagent is supplied frozen for in vitro diagnostic use in clinical laboratories. It is intended for single-use only in automated coagulation analyzers performing modified APTT assays. To maintain stability and integrity, storage must follow standard frozen reagent protocols, typically at or below -20°C. Avoid repeated thawing and refreezing, as this can compromise the reagent’s performance and diagnostic accuracy.

• Is this reagent suitable for reuse, or is it intended for single applications?

  This reagent is explicitly designed for single-use applications. Repeated use could introduce contamination or degradation of the plasma components, leading to inaccurate assay results. The immunodepleted and buffered formulation is optimized for one-time testing in automated systems, ensuring consistency and reliability per the manufacturer’s specifications.

• What regulatory pathway does CRYOcheck Factor VIII Deficient Plasma with VWF follow?

  The device is regulated under the FDA’s 510(k) clearance pathway, classified as substantially equivalent to a predicate device. It carries clearance number K222831 and falls under product code GJT, categorized as a Class II medical device. This classification reflects its role as a critical reagent in coagulation diagnostics, requiring compliance with stringent performance and safety standards.

• Does the reagent require any special handling or preparation before use?

  Before use, the frozen reagent must be thawed under controlled conditions to ensure uniform consistency. Thawing should be done slowly (e.g., in a refrigerator or at room temperature) to avoid thermal stress that could alter the plasma’s properties. Once thawed, the reagent should be used immediately in an automated coagulation analyzer, as prolonged exposure to room temperature may affect its stability and diagnostic reliability.