Hemochron Kaolin-Activated Heparin and Protamine Dosing Assays

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

510(k) Number

K010193 ↗

FDA Product Code

KFF

Device Class

Class II

Regulation

21 CFR Part 864.7525

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hemochron(R) Kact

  Class II

  FDA 510(k) K913861 Active Cleared 18 Oct 1991

• Hemochron Jr Generation II, Hemochron Jr Signature

  Class II

  FDA 510(k) K974799 Active Cleared 7 Jul 1998

• Hemochron Citrate Aptt

  Class II

  FDA 510(k) K972831 Active Cleared 20 Nov 1997

• Protime Microcoagulation System

  Class II

  FDA 510(k) K951072 Active Cleared 27 Oct 1995

• Tenderfoot

  Class II

  FDA 510(k) K883968 Active Cleared 1 Dec 1988

• Prothrombin Time (Pt) by Hemochron, Modification

  Class II

  FDA 510(k) K911995 Active Cleared 17 Jul 1991

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• What clinical purpose do these assays serve in managing patient care?

  These assays measure heparin and protamine levels in patient blood to quantify clotting times, helping clinicians adjust anticoagulant therapy. By assessing heparin’s effect on coagulation factor X or its neutralization by protamine sulfate, they enable precise dosing adjustments for safer and more effective anticoagulant management in clinical settings.

• Are these assays reusable, or are they intended for single-use only?

  The Hemochron Kaolin-Activated Heparin and Protamine Dosing Assays are explicitly designed for single-use in laboratory environments. This ensures accuracy and sterility, as reuse could compromise test reliability and patient safety.

• How should these assays be stored to maintain their accuracy?

  Proper storage is critical to preserve assay accuracy. While the exact conditions aren’t detailed here, the manufacturer’s protocols (provided with the Hemochron coagulation testing system) must be followed. Typically, this includes protecting from moisture, extreme temperatures, and contamination, as sterility is essential for in vitro diagnostics.

• What regulatory pathway was followed for FDA clearance of this device?

  The assays received FDA 510(k) clearance under product code KFF and regulation 864.7525, classified as a Class II device. The submission was reviewed by the Hematology (HE) Advisory Committee and determined to be substantially equivalent to a predicate device, following a traditional 510(k) pathway.

• Are these assays compatible only with the Hemochron coagulation testing system?

  Yes, these assays are supplied as part of the Hemochron coagulation testing system and are designed specifically for use within that system. They are not standalone devices and require the system’s infrastructure for accurate clotting time measurements.