Heparin ACA Analytical Test Pack

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

510(k) Number

K843201 ↗

FDA Product Code

KFF

Device Class

Class II

Regulation

21 CFR Part 864.7525

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from E.I. Dupont DE Nemours & Co., Inc. →

• What clinical setting is the Heparin ACA Analytical Test Pack intended for use in, and why is this important?

  The Heparin ACA Analytical Test Pack is designed exclusively for clinical laboratory settings, where trained personnel can perform precise quantitative measurements of heparin in biological samples. This is important because accurate heparin monitoring is critical for managing anticoagulant therapy in patients, ensuring safe and effective treatment while minimizing risks like bleeding or clotting complications.

• Is the Heparin ACA Analytical Test Pack reusable, and if not, what does this mean for cost and workflow efficiency?

  No, the Heparin ACA Analytical Test Pack is single-use only, meaning each pack is intended for one test cycle before disposal. This design ensures reliability and consistency in results, as reuse could introduce contamination or variability. While it may require more frequent restocking, it eliminates the need for cleaning or reprocessing, streamlining workflow and reducing the risk of cross-contamination in laboratory environments.

• What storage requirements should be followed to maintain the accuracy and performance of the Heparin ACA Analytical Test Pack?

  The test pack must be stored according to the accompanying instructions to preserve its integrity and performance. While specific storage conditions (e.g., temperature, humidity) aren’t detailed here, proper handling—such as keeping it in a dry, sealed environment and away from direct light—is essential. Adhering to these guidelines ensures the assay remains effective for its intended quantitative measurement of heparin in biological samples.

• How is the regulatory pathway for this device structured, and what does the FDA 510(k) clearance (K843201) imply about its safety and equivalence?

  The Heparin ACA Analytical Test Pack follows the FDA 510(k) clearance pathway, meaning it has been determined to be substantially equivalent to a legally marketed predicate device (as indicated by the *decision_code: SESE*). This clearance implies that the device meets FDA standards for safety and effectiveness, though it does not imply approval for specific clinical uses—only that it complies with regulatory requirements for its intended purpose as an *Assay, Heparin* in hematology.