Data-Fi Fibrin(Ogen) Degradation Prod.(Fdp)Det Set

• • Terminated Z-1040-05 FDA Unclassified (pre-2012) ·initiated 21 Jun 2005

  positive control shows weak agglutination reaction

510(k) Number

K872360 ↗

FDA Product Code

GHH

Device Class

Class II

Regulation

21 CFR Part 864.7320

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What clinical conditions might elevated fibrin(ogen) degradation products indicate when using this test kit?

  This test kit detects fibrin(ogen) degradation products (FDP), which are markers of fibrinolysis—a process where blood clots break down. Elevated levels may suggest conditions like disseminated intravascular coagulation (DIC) or other thromboembolic disorders, where abnormal clot formation and breakdown occur. Clinicians use this test to help diagnose or monitor these conditions in clinical hematology settings.

• How should the DATA-Fi Fibrin(ogen) Degradation Product Detection Set be stored, and is it reusable?

  The kit is supplied as a single-use reagent set, meaning it is not intended for reuse. Storage requires standard refrigeration—no special conditions are needed. Always check the packaging for expiration dates and handle as a sterile, in vitro diagnostic tool.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?

  The device received FDA clearance through a 510(k) Traditional Review under the Hematology advisory committee (HE). The submission was filed in 1987 and classified as substantially equivalent (SESE) to a predicate device, adhering to FDA’s Class II regulatory standards for in vitro diagnostics.

• Is this test kit compatible with any imaging modalities, such as MRI?

  No, this test kit is not intended for use in MRI or other imaging environments. It is strictly designed for in vitro diagnostic testing in clinical hematology laboratories to quantify fibrin(ogen) degradation products in blood samples.