Pathoplasma I & II (Path Citrated Human Plasma)

No FDA recalls on record, checked 22 Oct 2026.

Full name

Pathoplasma(R) I & II (Path Citrated Human Plasma)

510(k) Number

K924401 ↗

FDA Product Code

GGC

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Clibration Plasmas

  Class II

  FDA 510(k) K924404 Active Cleared 1 Dec 1992

• Opus Ck-Mb & Total Ck Controls

  Class I

  FDA 510(k) K960275 Active Cleared 25 Apr 1996

• D.A.T. (Tm) Amylase Reagent

  Class II

  FDA 510(k) K871943 Active Cleared 3 Jun 1987

• N/T Protein Control Sl

  Class I

  FDA 510(k) K964065 Active Cleared 6 Nov 1996

• Enzygnost(R) Anti-Cmv Igg

  Class II

  FDA 510(k) K913910 Active Cleared 28 Apr 1992

• N/T Rheumatology Control Sl/1 and Sl/2

  Class II

  FDA 510(k) K962373 Active Cleared 11 Jul 1996

See all devices from Behring Diagnostics, Inc. →

• What is Pathoplasma I & II used for in a clinical laboratory setting?

  Pathoplasma I & II is a citrated human plasma control designed to simulate abnormal plasma samples for hematology testing. It helps laboratories evaluate the accuracy and reliability of coagulation assays, ensuring instruments and reagents perform correctly when diagnosing blood clotting disorders. This makes it ideal for quality control checks in clinical settings.

• Are the Pathoplasma I & II vials single-use or reusable, and how should they be stored?

  The Pathoplasma I & II vials are sterile and intended for single-use only. Since they are liquid controls for in vitro diagnostic use, they should be stored following standard practices for citrated plasma controls—typically refrigerated between 2°C and 8°C, protected from light, and kept in a clean, controlled environment to maintain stability and sterility.

• What regulatory pathway was followed for FDA clearance of Pathoplasma I & II?

  Pathoplasma I & II received FDA clearance through a 510(k) submission (K924401), classified under product code GGC (Control, Plasma, Abnormal) and regulatory category II. The submission was reviewed by the Hematology (HE) Advisory Committee and determined to be substantially equivalent to a predicate device, with no third-party review required. The clearance date was February 22, 1994.

• How is Pathoplasma I & II different from regular plasma in a laboratory setting?

  Unlike regular plasma, Pathoplasma I & II is specifically formulated to mimic abnormal plasma samples, providing a controlled reference material for testing coagulation assays. This allows laboratories to assess instrument performance and reagent accuracy without relying on patient samples, ensuring consistent and reliable diagnostic results for conditions like hemophilia or thrombophilia.