← Product Code [DGC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC) · K042241 # K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (K042241) _Kamiya Biomedical Co. · DGC · Dec 10, 2004 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K042241 ## Device Facts - **Applicant:** Kamiya Biomedical Co. - **Product Code:** [DGC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC.md) - **Decision Date:** Dec 10, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5510 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use The Kamiya K-Assay® Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The Kamiya K-Assay® IgE Calibrator Set is an in vitro diagnostic reagent for the calibration of the Kamiya K-Assay® Total IgE Assay. ## Device Story K-ASSAY® Total IgE Assay is an in vitro diagnostic reagent kit utilizing immunoturbidimetric technology; measures circulating total IgE levels in human serum or plasma samples. Operates on automated clinical chemistry analyzers; reagents react with IgE in patient samples to produce turbidity proportional to IgE concentration. Output is quantitative IgE measurement used by clinicians to assist in diagnosing IgE-mediated allergic conditions. Intended for professional laboratory use; results interpreted alongside patient history and clinical findings. ## Clinical Evidence No clinical data provided; substantial equivalence established via bench testing and performance validation of the immunoturbidimetric assay. ## Technological Characteristics Immunoturbidimetric assay. Reagents: Tris HCl buffer and latex particles coated with goat anti-human IgE. Energy source: optical (570 nm light scattering). Platform: Roche Hitachi 917 analyzer. Calibration: 6-level human serum-based calibrators traceable to 2nd WHO International Reference Preparation (NIBSC 75/502). ## Regulatory Identification An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k042241 B. Purpose for Submission: This is a new device. C. Measurand: Total IgE D. Type of Test: Immunoturbidimetric, quantitative E. Applicant: Kamiya Biomedical Company F. Proprietary and Established Names: K-Assay® Total IgE Assay K-Assay® IgE Calibrator G. Regulatory Information: 1. Regulation section: 21 CFR§ 866.5510 Immunoglobulins A, G, M, D, E Immunological Test System 21 CFR§ 862.1150 Calibrator, secondary 2. Classification: Class II 3. Product code: DGC, IgE, Antigen, Antiserum, Control JIT, Calibrator, secondary 4. Panel: Immunology (82) Chemistry (75) H. Intended Use: 1. Intended use(s): The Kamiya K-Assay® Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The Kamiya K-Assay® IgE Calibrator Set is an in vitro diagnostic reagent for the calibration of the Kamiya K-Assay® Total IgE Assay. {1} 2. Indication(s) for use: Same as above. 3. Special conditions for use statement(s): The device is for prescription use only. 4. Special instrument requirements: Roche Diagnostics Hitachi 917 Analyzer I. Device Description: The Kamiya K-Assay® Total IgE Assay kit is composed of the following reagents that are ready to use: R1: Buffer Reagent (0.1M Tris hydrochloride buffer) R2: Antiserum Reagent (Latex particles coated with goat anti-human antibody) The Kamiya K-Assay® IgE Calibrator Set has 6 levels and is human-serum based. Controls are not provided in this kit. J. Substantial Equivalence Information: 1. Predicate device name(s): Pharmacia Unicap Total IgE Assay 2. Predicate 510(k) number(s): k964152 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | | K-Assay® IgE Assay | Unicap Total IgE Assay | | Intended Use | Quantitative determination of IgE | Same | | Matrix | Serum or plasma samples | Same | | Calibrator reference | 2^{nd} WHO International Reference preparation NIBSC Code No. 75/502 of human serum IgE | Same | | Calibrator matrix | Human serum base | Same | | Levels of calibrator | 6 levels | Same | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Methodology | Immunoturbidimetry | Fluoroimmunoassay | | Assay range | 20-2000IU/mL | 2-5000 IU/mL | | Volume of calibrators | 1.0 mL/vial | 0.2 ml/well | {2} # K. Standard/Guidance Document Referenced (if applicable): None referenced # L. Test Principle: Latex particles coated with antibody specific to human IgE form immune complexes in the presence of IgE from the sample. The immune complexes cause an increase in light scattering which is proportional to the concentration of IgE in the serum or plasma sample. The light scattering is measured by reading turbidity at $570~\mathrm{nm}$ . The sample IgE concentration is determined versus IgE standards of known concentration. # M. Performance Characteristics (if/when applicable): # 1. Analytical performance: # a. Precision/Reproducibility: # Within-Run Precision The following results were obtained on a Roche Hitachi 917 analyzer with 5 pooled human serum samples. Each sample was assayed 10 times in the same run. | | Sample 1 | Sample 2 | Sample 3 | Sample4 | Sample 5 | | --- | --- | --- | --- | --- | --- | | N | 10 | 10 | 10 | 10 | 10 | | Mean (IU/mL) | 105.3 | 174.1 | 350.5 | 1117.8 | 1908.6 | | SD (IU/mL) | 1.06 | 2.85 | 7.68 | 13.26 | 30.25 | | CV (%) | 1.01 | 1.63 | 2.2 | 1.2 | 1.6 | # Between- Run Precision The following results were obtained on a Roche Hitachi 917 analyzer with 5 pooled human serum samples. Each sample was assayed in replicates of 5 over 10 days. A new calibration is performed before each days testing. Each value is the average of 5 measurements | | Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 | | --- | --- | --- | --- | --- | --- | | N | 10 | 10 | 10 | 10 | 10 | | Mean (IU/mL) | 105.4 | 177.6 | 663.7 | 2147.5 | 3304.7 | | SD (IU/mL) | 2.72 | 3.24 | 11.22 | 33.56 | 16.67 | | CV (%) | 2.58 | 1.82 | 1.69 | 1.56 | 0.50 | # b. Linearity/assay reportable range: Low (600 IU/mL), medium (1200 IU/mL), and high (2000 IU/mL) controls were serially diluted (2-fold) with saline that contains $1\%$ BSA. The samples were assayed and the R value of the regression line calculated. The criteria are set as follows: R value $\geq 0.99$ and the measured value must be $\pm 10\%$ of the theoretical value. The regression equations are as follows: Low range linearity $y = 54.764x - 8.1818$ , $R = 0.9991$ Medium range linearity $y = 110.55x - 3.0455$ , $R = 0.9998$ High range linearity $y = 189.89x - 4.3636$ , $R = 0.9992$ The assay range is $10 - 2000\mathrm{IU / mL}$ # c. Traceability, Stability, Expected values (controls, calibrators, or methods): The $2^{\mathrm{nd}}$ WHO International Reference Preparation NIBSC Code No. 75/502 of {3} human serum IgE was the reference material used for value assignment of the K-Assay IgE calibrator. IgE standardization procedure for the calibrator was provided. First, a primary standard was prepared using the 2nd WHO International Reference Preparation NIBSC Code No. 75/502 according to package insert. Secondary standards using pooled plasma with high IgE value were prepared. IgE values for the secondary standards were then evaluated. The standard curves were prepared using 4 different lots of assay reagents and used to calculate the mean value of the primary standard (n=5). Value assignment for the calibrator was based on the value of the primary standard measured previously. Accelerated stability studies were performed and the following results were obtained: - The IgE assay reagent and calibrator is stable for at least 12 months when stored unopened at 4°C – 10°C. - The IgE assay reagent and calibrator is stable for at least 1 month when stored opened at 4°C (tightly capped). d. Detection limit: The analytical sensitivity is defined as the lowest IgE concentration that the analyzer can distinguish using a mean±2 standard deviation (SD). The lowest IgE sample that had an absorbance range (mean±2 SD) above the absorbance range for saline was 10 IU/mL. e. Analytical specificity Interference Study: The following interference samples were diluted serially with serum diluent. IgE was measured in each of the 6 diluted samples and the % recovery calculated based on IgE concentration of the serum. No interference was observed up to the measured concentration of each interferent. Bilirubin F (18.5 mg/dL) Bilirubin C (21.6 mg/dL) Hemoglobin (467 mg/dL) RF sample (500 IU/mL) Sodium citrate (15.0 mg/mL) f. Assay cut-off: See Expected Values section. 2. Comparison studies: a. Method comparison with predicate device: The Kamiya K-ASSAY® Total IgE assay was compared to the Pharmacia Unicap Total IgE assay. 80 serum samples were tested on the Roche Hitachi 917. Sixty one of the samples were single donor serum from male and female adults obtained from Blood Services. 19 samples were from healthy Japanese female adults. No other demographic information was available. A linear regression equation of y = 0.98x + 10.62 was obtained, where y is the 4 {4} Kamiya K-Assay® and x is Pharmacia Unicap. The correlation coefficient R was 0.9928. The 95% CI of the slope is 0.72 to 1.25 and the 95% CI of the y-intercept is -15.43 to 36.65 IU/mL. The standard error is 94.11 IU/mL. b. Matrix comparison: Fifty one serum and sodium citrate plasma samples covering the entire measuring range of the Kamiya K-Assay® Total IgE Assay were run using on the Roche Hitachi 917. The regression equation showed y = 1.1944x + 9.1707, R = 0.9992, where y is plasma IgE values and x is serum IgE values. The 95% CI of the slope is 1.18 to 1.21 and 95% CI of the y-intercept is 1.32 to 17.02 IU/mL. The standard error is 25.63 IU/mL. 3. Clinical studies: a. Clinical Sensitivity: Not provided b. Clinical specificity: Not provided c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: 413 random, non-pooled individual human serums were used in this study. This data was collected from Japanese patients. The top 35.9% was excluded from the data. Japanese Ministry of Health, Labor, and Welfare performed a study on 36,506 individuals and found that 35.9% of healthy populations were clinically allergic. The mean ±1.96 standard deviations of the corrected population were set to be the normal range which is less than 178 IU/mL. The exact percentage of the allergic population in the U.S has not been defined. A reference range for U.S. populations (<300 IU/mL) cited in the literature (Jacobs DS, et al, "Laboratory Test Handbook, 4th edition" 1996, p409) has been added to the package insert. A statement has been added to the Limitations of the Procedure that states the reference range was calculated using Japanese adults. 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. --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K042241](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGC/K042241) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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