CRYOcheck Chromogenic Factor VIII Test

Full name

CRYOcheck Chromogenic Factor VIII

510(k) Number

K251440 ↗

FDA Product Code

GGP

FDA applicant

Precision Biologic, Inc.

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Cryocheck Clot S

  Class II

  FDA 510(k) K043571 Active Cleared 18 Mar 2005

• CRYOcheck FVIII Inhibitor Kit

  Class II

  FDA 510(k) K183440 Active Cleared 12 Mar 2019

• CRYOcheck Factor VIII Deficient Plasma with VWF

  Class II

  FDA 510(k) K222831 Active Cleared 13 Sep 2023

• Cryocheck Clot Apcr

  Class II

  FDA 510(k) K060284 Active Cleared 10 May 2006

• CRYOcheck Chromogenic Factor IX

  Class II

  FDA 510(k) K214002 Active Cleared 23 Dec 2022

• CryoCheck Clot C

  Class II

  CE/IVDD FDA 510(k) K040987 Active Cleared 18 Jun 2004

See all devices from Precision Biologic Inc →

• What is the CRYOcheck Chromogenic Factor VIII Test used for in clinical practice?

  The CRYOcheck Chromogenic Factor VIII Test is designed for the qualitative and quantitative assessment of Factor VIII deficiency in plasma samples. It uses chromogenic technology to measure Factor VIII activity levels, which helps clinicians diagnose and monitor hemophilia A—a bleeding disorder caused by low levels of Factor VIII. This makes it a key tool in hematology labs for evaluating patients suspected of having or already diagnosed with this condition.

• Is the CRYOcheck Chromogenic Factor VIII Test sterile, and how should it be stored?

  The CRYOcheck Chromogenic Factor VIII Test is supplied as a non-sterile diagnostic kit, meaning it is not intended for sterile procedures. For optimal performance, it should be stored under refrigeration at 2–8°C. No additional special storage conditions are required beyond this temperature range.

• Can this test be reused, or is it intended for single-use only?

  The CRYOcheck Chromogenic Factor VIII Test is explicitly labeled as a single-use diagnostic kit. Each kit is designed for one test cycle only, ensuring accuracy and reliability for a single plasma sample analysis. Reuse is not recommended or supported by the manufacturer.

• What regulatory pathways does the CRYOcheck Chromogenic Factor VIII Test follow, and how does this affect its use?

  The test is regulated under FDA 510(k) clearance (K251440) and complies with the In Vitro Diagnostic Device Directive (IVDD). It is classified as a Class II device under FDA regulations, meaning it undergoes rigorous review by the Hematology (HE) Advisory Committee to ensure safety and effectiveness. This classification reflects its role in diagnosing and monitoring serious conditions like hemophilia A, where precision is critical.

• Who manufactures the CRYOcheck Chromogenic Factor VIII Test, and where is it based?

  The CRYOcheck Chromogenic Factor VIII Test is manufactured by Precision Biologic Inc, a company based in Dartmouth, Nova Scotia, Canada (postal code B3B 0A9). The manufacturer’s contact for inquiries is listed as Karen Black, though specific contact details for purchasing or technical support should be verified through official channels.