FS Test Kit

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

510(k) Number

K854015 ↗

FDA Product Code

JBN

Device Class

Class II

Regulation

21 CFR Part 864.7300

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Bioproducts Co. →

• What clinical area does the FS Test Kit primarily support, and how does it help in patient evaluation?

  The FS Test Kit is designed for use in clinical hematology laboratories to assess fibrin formation in blood samples. It detects the presence of fibrin monomers, which indicate abnormal clotting processes or fibrinolytic activity. This aids clinicians in evaluating coagulation disorders, helping to diagnose conditions related to blood clotting dysfunction.

• Is the FS Test Kit intended for repeated use, or is it a single-use diagnostic reagent?

  The FS Test Kit is explicitly labeled as a single-use diagnostic reagent. This means each kit is intended for one-time use in a blood sample test, ensuring accuracy and preventing cross-contamination between patients.

• What storage conditions are required for the FS Test Kit, and does it need special handling?

  The FS Test Kit does not require special storage conditions beyond standard refrigeration. This ensures stability while maintaining its effectiveness for detecting fibrin monomers in blood samples.

• How was the FS Test Kit approved by the FDA, and what does its classification under 21 CFR 864.7300 mean?

  The FS Test Kit received FDA 510(k) clearance (K854015) under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. Its classification under 21 CFR 864.7300 confirms it is a Fibrin Monomer Paracoagulation device, regulated for in vitro diagnostic use in hematology.