Cryo Check Factor XII Deficient Plasma Model FDP12-10 (1.0ml) and FDP12-15 (1.5ml)

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

510(k) Number

K981174 ↗

FDA Product Code

GJT

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Saf Fecal Collection Kit

  Class I

  FDA 510(k) K885244 Active Cleared 21 Mar 1989

• Cryo Check Factor V Deficient Plasma

  Class II

  FDA 510(k) K971223 Active Cleared 22 Jul 1997

• Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.OML) and FDP11-15 (1.5ml)

  Class II

  FDA 510(k) K981173 Active Cleared 13 Jan 1999

• Cryo Check Apc Resistant Plasma

  Class II

  FDA 510(k) K971222 Active Cleared 19 Aug 1997

• Aptt Reagent

  Class II

  FDA 510(k) K884856 Active Cleared 30 Jan 1989

• Cryo Check Factor IX Deficient Plasma

  Class II

  FDA 510(k) K971226 Active Cleared 18 Jul 1997

See all devices from Precision Biologicals, Inc. →

• What is the primary use of the CRYO CHECK Factor XII Deficient Plasma in a clinical laboratory setting?

  This plasma is specifically designed as a substrate for clot-based Factor XII assays, serving as a deficient control to validate test accuracy. It is immunodepleted and platelet-poor, with less than 1% residual Factor XII activity, ensuring reliable results when assessing Factor XII levels in patient samples.

• Are the 1.0 mL (FDP12-10) and 1.5 mL (FDP12-15) models interchangeable in testing, or do they serve distinct purposes?

  Both models are single-use plasma samples with identical composition and intended use, differing only in volume. The choice between them depends on laboratory workflow and sample requirements—1.0 mL for smaller assays or limited testing, and 1.5 mL for larger batches or repeated testing.

• How should the plasma be stored and prepared for use, given it is supplied frozen?

  The plasma must be stored frozen according to standard frozen plasma protocols to maintain integrity. Thawing should be done slowly at 37°C (or per manufacturer guidelines) and used immediately after thawing, as it is a single-use product. Avoid repeated freeze-thaw cycles to preserve its deficient Factor XII characteristics.

• Does this product require any special handling or validation beyond standard plasma storage, given its low residual Factor XII activity?

  Beyond standard frozen plasma storage, no additional handling is required. Each lot includes a certificate of analysis documenting residual Factor XII activity (<1%) and levels of other coagulation factors, ensuring traceability and validation for assay calibration. Always verify the COA before use.