Enzymun-Test Ferritin

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K860137 ↗

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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See all devices from Boehringer Mannheim Corp. →

• What is the Enzymun-Test Ferritin used for?

  The Enzymun-Test Ferritin is designed for the quantitative measurement of ferritin levels in human serum or plasma. Ferritin is a key biomarker for diagnosing and monitoring conditions related to iron metabolism, such as iron deficiency, anemia, and hemochromatosis. By providing accurate ferritin readings, this device helps clinicians assess iron storage and diagnose disorders where ferritin levels are abnormal.

• How is the Enzymun-Test Ferritin supplied, and what does the kit include?

  The Enzymun-Test Ferritin is supplied as a complete kit containing all necessary reagents, controls, and components required to perform enzyme immunoassays. This includes antiserum, antigen, and control materials to ensure accurate and reliable ferritin measurements. The kit is intended for single-use in clinical laboratory settings, adhering to standard laboratory practices for handling and testing.

• Is the Enzymun-Test Ferritin sterile, and how should it be stored?

  The Enzymun-Test Ferritin is intended for single-use in clinical laboratory settings, which implies it is supplied in a sterile or aseptic state to prevent contamination during testing. Storage instructions are not explicitly detailed in the provided data, but standard practice for immunoassay kits requires storage in a clean, dry environment, protected from extreme temperatures and light. Always follow the manufacturer’s guidelines for optimal performance and sterility.

• Can the Enzymun-Test Ferritin kit be reused, or is it designed for single-use only?

  The Enzymun-Test Ferritin is explicitly designed for single-use in clinical laboratory settings. Reusing components from this kit could compromise accuracy, introduce contamination, or invalidate results. Each kit is intended to be used once per test, ensuring reliable and reproducible ferritin measurements.

• What regulatory pathway does the Enzymun-Test Ferritin follow, and when was it cleared?

  The Enzymun-Test Ferritin holds an FDA 510(k) clearance under product code DBF, with a decision date of March 28, 1986. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device at the time of submission. The device was reviewed by the Immunology (IM) Advisory Committee and classified under device class 2, reflecting its role in diagnosing or monitoring medical conditions.