RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367

{0} 1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K050709 B. Purpose for Submission: Seek clearance for a modification to a currently cleared device (K840011) C. Measurand: Normal and abnormal hemoglobin D. Type of Test: Semi-Quantitative isoelectric focusing assay E. Applicant: Wallac Oy F. Proprietary and Established Names: Resolve Hemoglobin Kit JB-2 Staining System G. Regulatory Information: 1. Regulation section: 21 CFR 864.7415 2. Classification: Class II 3. Product code: GKA 4. Panel: {1} 81 Hematology H. Intended Use: 1. Intended use(s): The RESOLVE Systems Hemoglobin kit is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing. 2. Indication(s) for use: The assay is intended for use as an aid in the diagnosis of neonatal and adult hemoglobinopathies. 3. Special conditions for use statement(s): 4. Special instrument requirements: The kit is designed to be run on a flat-bed electrofocusing unit. I. Device Description: The RESOLVE Hemoglobin kit is available in 3 configurations (120 tests, 360 tests, 3600 tests). Each kit contains: | Component | 135 Tests | 360 tests | 3600tests | | --- | --- | --- | --- | | Agarose IEF Gel | 5 | 5 | 50 | | Anode Solution | 30 ml | 120 ml | 480ml | | Cathode Solution | 30 ml | 60 ml | 240 ml | | HB Elution Solution | 30 ml | 30 ml | 240 ml | | IEF Electrode Wicks | 12 | 15 | 2 X 80 | | Blotting Papers | 6 | 6 | 60 | | Blotting Strips | 6 | - | - | | Sample Application Templates | 5 | Order separately | Order separately | J. Substantial Equivalence Information: 1. Predicate device name(s): BioRad VARIANT Sickle Cell Short Program BioRad Variant nbs Sickle Cell Program {2} 2. Predicate 510(k) number(s): K924813 K051072 3. Comparison with predicate: | Similarities | | | | | --- | --- | --- | --- | | Item | Device | VARIANT Sickle Cell Short Program | VARIANT nbs Sickle Cell Program | | Intended Use | To separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins | Qualitative screen for the presence of hemoglobin's F, A, S, D, C and E in eluates of neonatal blood collected on filter paper | Qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper | | Analytes identified | Hemoglobins F,A,E,D,S,C. In addition G and α- and β-thalassemia | Hemoglobins F,A,E,S,S and C | Hemoglobins F,A,E,D,S and C | | Differences | | | | | --- | --- | --- | --- | | Item | Device | VARIANT Sickle Cell Short Program | VARIANT nbs Sickle Cell Program | | Sample | Neonatal dried blood spots, whole blood and cord blood | Dried blood spots | Dried blood spots | | Target Population | Neonates and adults | Neonates | Neonates | {3} 4 | Differences | | | | | --- | --- | --- | --- | | Item | Device | VARIANT Sickle Cell Short Program | VARIANT nbs Sickle Cell Program | | Principle | IEF | HPLC | HPLC | ## K. Standard/Guidance Document Referenced (if applicable): ## L. Test Principle: Whole blood or cord blood, on a filter spot or collected into an EDTA or heparinized tube, is treated with a Hb Elution Solution to inhibit methemoglobin formation. The solution is then placed on an agarose gel containing RESOLVE Ampholytes pH 6-8, and the gel is placed on the electrofocusing unit. When an electrical current is applied to the gel, the hemoglobin variants possessing individual isoelectric points (pl's), migrate through the gel. When an individual variant's pl equals the pH in the gel, it ceases migration and forms a discrete band. When all hemoglobin bands have focused, the gel is fixed in trichloroacetic acid. Hemoglobin bands can be visualized by using the JB-2 Staining System. Stained or unstained gels can be scanned by a densitometer to estimate the percentages of normal and variant hemoglobins. ## M. Performance Characteristics (if/when applicable): ### 1. Analytical performance: #### a. Precision/Reproducibility: Variation was estimated by measuring the distance of certain Hb bands of FASC controls used in the comparison studies. The analysis of variance was used to calculate the following: | | n | Average distance (mm) | Within-gel precision (CV%) | Between-gel Precision (%CV) | Total precision Within laboratory (%CV) | | --- | --- | --- | --- | --- | --- | | HbA_{1c} vs. Hb C | 216 | 17.8 | 2.2 | 1.8 | 2.8 | {4} | Hb A vs. Hb F | 223 | 2.1 | 3.3 | 2.9 | 4.4 | | --- | --- | --- | --- | --- | --- | b. Linearity/assay reportable range: c. Traceability, Stability, Expected values (controls, calibrators, or methods): d. Detection limit: e. Analytical specificity: f. Assay cut-off: # 2. Comparison studies: a. Method comparison with predicate device: The RESOLVE Hemoglobin system was compared to HPLC. Samples included $60\%$ from normal patients, $20\%$ from hemoglobin combinations having Hb S and $20\%$ from other hemoglobin variants to include Hb C, D, E, G-Philadelphia, $\alpha$ -thalassemia and $\beta$ -thalassemia. | | n | HPLC | % Agreement | Lower 95% CI | | --- | --- | --- | --- | --- | | Site 1 | 850 | 1 | 99.8 | 99.2 | | Site 2 | 837 | 2 | 97.7 | 96.7 | | Site 3 | 1031 | 1 | 99.1 | 98.4 | b. Matrix comparison: # 3. Clinical studies: a. Clinical Sensitivity: {5} b. Clinical specificity: c. Other clinical supportive data (when a. and b. are not applicable): 4. Clinical cut-off: 5. Expected values/Reference range: 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. 6