CryoCheck Clot C

510(k) Number

K040987 ↗

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 Chromogenic Factor VIII Test

  Class II

  CE/IVDD FDA 510(k) K251440 Active Cleared 25 Aug 2025

• 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

See all devices from Precision Biologic Inc →

• What specific coagulation factor does the CryoCheck Clot C test for, and how does it work?

  The CryoCheck Clot C is designed to detect and quantify deficiencies in Factor XIII, a critical coagulation factor. It works by assessing clot formation and stability in patient samples using a cryoprecipitate-based assay. The test evaluates how well a patient’s blood clots under controlled conditions, helping identify if Factor XIII levels are insufficient, which can impair normal clotting processes.

• Is the CryoCheck Clot C kit sterile, and how should it be handled given its single-use nature?

  The CryoCheck Clot C is not sterile and must be handled under controlled conditions to maintain assay integrity. Since it is a single-use diagnostic kit, each test should be performed with a new kit to avoid cross-contamination or degradation of results. Proper aseptic techniques and adherence to manufacturer guidelines are essential during preparation and testing.

• What type of clinical setting or laboratory is this device intended for, and what reagents are required?

  The CryoCheck Clot C is intended for in vitro use in clinical laboratories, specifically for hematology diagnostics. It requires cryoprecipitate as a reagent to perform the assay. The test is designed for use by trained laboratory personnel who can handle coagulation testing and interpret results based on clot formation and stability.

• How is the CryoCheck Clot C regulated, and what does its classification under the In Vitro Diagnostic Device Directive (IVDD) mean?

  The CryoCheck Clot C is regulated under FDA 510(k) clearance and complies with the In Vitro Diagnostic Device Directive (IVDD). Its classification under GGP (Group G, General Purpose) for coagulation tests means it falls under a regulatory category that ensures its safety, performance, and clinical accuracy for detecting and quantifying coagulation factor deficiencies, particularly Factor XIII.

• Are there multiple sizes or models of the CryoCheck Clot C, or is it available in a single configuration?

  The provided data does not specify multiple sizes or models for the CryoCheck Clot C. It is described as a single-use diagnostic kit for qualitative and quantitative Factor XIII deficiency testing, implying a standardized configuration. For exact details on kit composition or variations, refer to the manufacturer’s documentation or contact Precision Biologic Inc.