K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
Device Facts
| Record ID | K121232 |
|---|---|
| Device Name | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR |
| Applicant | Kamiya Biomedical Company |
| Product Code | DBF · Immunology |
| Decision Date | May 24, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5340 |
| Device Class | Class 2 |
Indications for Use
The K-ASSAY® Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use. The K-ASSAY® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. For in vitro diagnostic use.
Device Story
K-ASSAY® Ferritin (2nd Gen.) is a latex-enhanced immuno-turbidimetric assay for quantitative ferritin measurement in human serum/plasma. Input: patient serum/plasma samples mixed with latex particles sensitized with mouse monoclonal anti-human ferritin antibodies. Principle: immune complex formation measured via turbidimetry on Beckman/Olympus AU680 analyzer; signal correlates to ferritin concentration. Output: quantitative ferritin level (ng/mL) calculated via interpolation on a 6-point calibration curve. Used in clinical laboratories by technicians/pathologists to assist in diagnosing iron-related disorders (overload/anemia). Benefits: provides standardized, automated diagnostic data for iron status assessment.
Clinical Evidence
Bench testing only. Performance evaluated per CLSI guidelines (EP05-A2, EP06-A, EP17-A, EP07-A2, EP09-A2-IR). Precision (CV% < 1% between-lot), linearity (5-1,000 ng/mL), LoQ (5.0 ng/mL), and interference studies (no significant interference for bilirubin, hemoglobin, RF, etc.) were conducted. Method comparison with predicate (n=54) showed strong correlation (y = 1.0057x + 0.0968). Matrix comparison confirmed suitability of serum, EDTA plasma, and heparin plasma.
Technological Characteristics
Latex-enhanced immuno-turbidimetric assay. Reagents: HEPES buffer, latex particles sensitized with mouse monoclonal anti-human ferritin antibodies, sodium azide preservative. Form factor: liquid stable reagents and calibrators. Connectivity: designed for use on Beckman/Olympus AU680 clinical chemistry analyzer. Standardization: traceable to WHO 2nd International Ferritin Standard (lot 80/578).
Indications for Use
Indicated for quantitative determination of ferritin in human serum and plasma to aid in diagnosis of iron overload and iron deficiency anemia. Prescription use only.
Regulatory Classification
Identification
A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.
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