RDI HSFERRITIN KIT

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY A. 510(k) Number: K053211 B. Purpose for Submission: Clearance of new assay for ferritin C. Measurand: Ferritin D. Type of Test: Turbidimetric immunoassay E. Applicant: Reference Diagnostics, Inc. F. Proprietary and Established Names: Proprietary Name: RDI Ferritin Established Name: Ferritin, antigen, antiserum, control G. Regulatory Information: 1. Regulation section: 21 CFR § 866.5340 Ferritin Immunological test system. 2. Classification: Class II 3. Product code: DBF 4. Panel: Immunology H. Intended Use: 1. Intended use(s): The RDI Ferritin kit is for quantitative measurement of ferritin in human serum or plasma. Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis. 2. Indication(s) for use: The RDI Ferritin kit is for quantitative measurement of ferritin in human serum or plasma. Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis. 3. Special conditions for use statement(s): Prescription Use 4. Special instrument requirements: Hitachi 911 analyzer. I. Device Description: The RDI Ferritin is a immunoturbidimetric assay. Serum ferritin in the presence of anti-ferritin attached to latex microparticles and glycine buffer (pH 8.3) forms an antigen-antibody reaction resulting in agglutination of latex microparticles. The agglutination is measured turbidimetrically by an absorbance change at a wave length of 600 nm. The magnitude of the absorbance change is proportional to the ferritin concentration in the sample. A standard curve is generated with known concentrations {1} of ferritin to calculate the values. ## J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Health Care Corporation- ADVIA Centaur Ferritin 2. Predicate 510(k) number(s): K905770 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Indication for use | Quantitative measurement of ferritin in human serum/plasma as an aid in assessing iron deficiency anemia, hemochromatosis. | Same | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Calibrator Levels | 6 – in liquid form | 5 lyophilized powder | | Reference material | The assigned values are referenced to WHO 3rd International Standard for Ferritin, Recombinant, (94/572). | Reference material WHO 80/58-recombinant ferritin | | Assay method | Turbidimetric immunoassay | 2 site sandwich – chemiluminescent immunoassay | | Matrix | Serum/heparinized plasma | Serum/heparinized plasma/EDTA plasma | | Analyzer | 911 Hitachi | ADVIA Centaur | | Minimum detectable concentration | 7.6ng/ml | 0.5ng/ml | ## K. Standard/Guidance Document Referenced (if applicable): None referenced ## L. Test Principle: Turbidimetric immunoassay ## M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision studies were performed using 3 concentrations. {2} | Within Run (n=20) | | | | | --- | --- | --- | --- | | Pool | 1 | 2 | 3 | | Mean mg/ml | 29.5 | 182.7 | 395.7 | | SD | 1.3 | 2.2 | 2.6 | | CV (%) | 4.5 | 1.2 | 0.6 | | Between Run (n=20) | | | | | --- | --- | --- | --- | | Pool | 1 | 2 | 3 | | Mean mg/ml | 31.4 | 183.0 | 400.7 | | SD | 2.0 | 10.1 | 19.7 | | CV (%) | 6.5 | 5.5 | 4.9 | b. Linearity/assay reportable range: A serum pool with high concentration of ferritin was diluted with normal saline and assayed by the RDI ferritin method. Results are as described by the sponsor. | | Undiluted sample | 1:5 dilution | 1:10 dilution | | --- | --- | --- | --- | | Hitachi 911 | >1200 ng/ml | 587.8 ng/ml | 3136 ng/ml | | Calculated | | 2939 ng/ml | 3136 ng/ml | | % recovery | | 103.7 % | 110.6% | c. Traceability, Stability, Expected values (controls, calibrators, or methods): The RDI Ferritin calibrators were prepared by diluting a stock solution of human ferritin liver antigen purchased from a commercial source with non-fat dry milk in TBS to achieve the following target concentrations: 0 (blank), 25, 50, 200, 800, and 1200 ng/ml. Ferritin calibrators were prepared using the 3rd International Standard for Ferritin, Recombinant, NIBSC code 94/572 (6.3 micrograms/mL) diluted to the respective levels as the RDI Ferritin calibrators. They were used to calibrate the RDI Ferritin assay on the Roche Hitachi 911 and the RDI Ferritin calibrators were assayed in triplicate along with the NIBSC calibrators. In order to avoid potential errors introduced by mathematical curve-fitting, the absolute absorbance of each RDI calibrator and the absorbance obtained for the corresponding concentration of NIBSC reference material were compared. d. Detection limit: Minimum detectable concentration is stated as 7.6 ng/ml e. Analytical specificity: Not provided f. Assay cut-off: Not provided. However, the reference range is supposed to be used. 2. Comparison studies: a. Method comparison with predicate device: RDI ferritin assay using Hitachi 911 was Bayer ADVIA Centaur ferritin assay using 117 patient samples ranging from 9-1055 ng/ml. Linear regression analysis showed y=0.982 x +11.5 ng/ml with a correlation coefficient (r) of 0.997. {3} b. Matrix comparison: Serum vs. sodium heparin plasma: y = 1.0134x - 4.1985 R2 = 0.9993 (n = 25) Serum vs. lithium heparin plasma: y = 1.016x - 6.3405 R2 = 0.9996 (n = 25) 3. Clinical studies: a. Clinical Sensitivity: Not provided b. Clinical specificity: Not provided c. Other clinical supportive data: Not provided 4. Clinical cut-off: Not provided 5. Expected values/Reference range: Reference intervals for serum ferritin are stated as 20-250 ng/ml for men and 10-120 ng/ml for women. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10 O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.