Heparsorb

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K781781 ↗

FDA Product Code

GJA

Device Class

Class II

Regulation

21 CFR Part 864.7875

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is Heparsorb used for in a hematology lab?

  Heparsorb is designed to reverse the anticoagulant effects of heparin in coagulation assays. By neutralizing heparin, it allows for precise measurement of thrombin time—a key parameter in diagnosing blood clotting disorders and monitoring patients on anticoagulant therapy. This ensures accurate results when evaluating conditions like hemophilia or assessing heparin-based treatments.

• How is Heparsorb supplied and intended for use?

  Heparsorb comes as tablet formulations intended exclusively for in vitro laboratory use. Each tablet is meant for single-use only, eliminating the need for additional sterilization beyond standard laboratory hygiene practices. The tablets are not meant for reuse or external applications like MRI compatibility.

• Does Heparsorb require special storage conditions?

  Regulatory records do not specify unique storage requirements for Heparsorb, but it follows typical laboratory protocols for coagulation reagents. This generally includes protection from extreme temperatures, moisture, and contamination. Always refer to the manufacturer’s instructions for precise storage guidance.

• Is Heparsorb approved for clinical use, and how?

  Yes, Heparsorb is cleared for clinical use under the FDA’s 510(k) pathway, specifically through Traditional review. The clearance (K781781) was granted in 1979 with a determination of Substantially Equivalent to a predicate device. This means it meets regulatory standards for safety and effectiveness as a heparin neutralizer in coagulation testing.

• Can Heparsorb be used with other coagulation tests?

  Heparsorb is specifically designed for use in thrombin time assays to neutralize heparin interference. While its primary purpose is to ensure accurate thrombin time results, its application is limited to scenarios where heparin contamination could skew coagulation measurements. Always verify compatibility with your lab’s specific assay protocols before use.