Phase II Ferritin Radioimmunoassay Kit

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

510(k) Number

K862960 ↗

FDA Product Code

DBF

Device Class

Class II

Regulation

21 CFR Part 866.5340

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What clinical conditions is this ferritin assay kit primarily used to diagnose or monitor?

  This kit is designed for the quantitative measurement of ferritin antigen in serum or plasma, which aids in diagnosing and monitoring conditions like iron overload disorders (such as hemochromatosis) and various types of anemia. Ferritin levels serve as a key biomarker for iron storage and deficiency, helping clinicians assess these conditions.

• Is this kit intended for single-use or repeated use in a laboratory setting?

  The Phase II Ferritin Radioimmunoassay Kit is explicitly labeled as a single-use diagnostic reagent set. Each kit is meant for one-time use in laboratory testing, ensuring accuracy and preventing cross-contamination.

• What storage requirements does this kit have, and can it be kept at room temperature?

  The kit requires standard refrigeration for storage—no special conditions are needed. It is not designed for room-temperature stability, so refrigeration (typically between 2°C and 8°C) is essential to maintain its integrity and performance.

• How is this device regulated by the FDA, and what does the clearance classification mean for users?

  The kit received FDA 510(k) clearance (K862960) under 21 CFR 866.5340, classifying it as a Class II—Moderate Risk device. This means it has undergone review by the Immunology (IM) advisory committee and is deemed substantially equivalent to a predicate device, ensuring it meets safety and performance standards for laboratory use.

• Does this kit include all necessary components for testing, or are additional reagents required?

  The kit is supplied as a complete diagnostic reagent set for laboratory use, meaning it includes all required components for performing the two-site solid-phase radioimmunoassay. No additional reagents are needed beyond those provided in the kit.