Ferritin-Latex, Models 1418-2070, 1418-0279
by Medicon Hellas S.A EUDAMED510(k)
Active
510(k) K062746
Overview
The Ferritin-Latex, Models 1418-2070 and 1418-0279, is an immunology diagnostic reagent used for the qualitative detection of ferritin in serum or plasma. It employs latex agglutination technology to identify ferritin antigens, aiding in the assessment of iron storage disorders and related conditions.
These models are supplied as in vitro diagnostic reagents, intended for single-use in clinical laboratory settings. They are authorized under the FDA’s 510(k) pathway as substantially equivalent to predicate devices and comply with the EU’s In Vitro Diagnostic Regulation (IVDR). Sterility and performance are ensured through manufacturer-controlled processes, with no MRI safety considerations. Storage requires refrigeration at 2–8°C and protection from light.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK062746 | Date20 Nov 2006 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5340
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Medicon Hellas S.A
Questions
What clinical conditions can the Ferritin-Latex reagent help assess in patients?
The Ferritin-Latex reagent is designed for the qualitative detection of ferritin in serum or plasma, which aids in evaluating iron storage disorders such as iron deficiency, iron overload (e.g., hemochromatosis), and other related conditions. By identifying ferritin antigens through latex agglutination, it supports diagnostic assessments in immunology-related clinical settings.
How should the Ferritin-Latex reagent be stored, and why is this important?
The Ferritin-Latex reagent must be stored refrigerated between 2–8°C while protected from light. Proper storage is critical to maintain sterility and ensure the reagent’s performance, as exposure to heat or light could degrade its sensitivity or alter its reactivity in detecting ferritin antigens.
Are there multiple models of the Ferritin-Latex reagent, and how do they differ?
Yes, there are two models: 1418-2070 and 1418-0279. While both are immunology diagnostic reagents for qualitative ferritin detection, the specific differences between them (e.g., lot size, formulation variations, or intended use nuances) are not detailed in the provided data. Clinicians should refer to the manufacturer’s instructions for model-specific guidance.
Is the Ferritin-Latex reagent intended for single-use or repeated testing, and why?
The Ferritin-Latex reagent is explicitly supplied for single-use in clinical laboratory settings. This design ensures sterility and reliability per each test, preventing cross-contamination or degradation of diagnostic accuracy from reuse. Single-use aligns with standard practices for immunology reagents to maintain precision in ferritin detection.
What regulatory pathways does the Ferritin-Latex reagent follow in the U.S. and EU?
In the U.S., the Ferritin-Latex reagent is authorized through the FDA’s 510(k) pathway, classified as substantially equivalent to predicate devices under decision code SESE (Substantially Equivalent, Special). In the EU, it complies with the In Vitro Diagnostic Regulation (IVDR), ensuring adherence to stringent diagnostic performance and safety standards for immunology reagents.