← Product Code [JZG](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG) · K032692 # DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (K032692) _Dako A/S · JZG · Jan 22, 2004 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K032692 ## Device Facts - **Applicant:** Dako A/S - **Product Code:** [JZG](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG.md) - **Decision Date:** Jan 22, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5630 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use For in vitro diagnostic use. DakoCytomation Beta-2-Microglobulin Kit is intended for the quantitative determination of beta-2-microglobulin in human serum and plasma by rate nephelometry on IMMAGE® Immunochemistry Systems. Measurement of beta-2-microglobulin aids in the diagnosis of patients with active rheumatoid arthritis and kidney disease. ## Device Story Microparticle immunoassay for quantitative determination of beta-2-microglobulin (B2M) in human serum and plasma. Kit contains polystyrene particles coupled with polyclonal rabbit anti-human B2M antibodies. Patient specimen mixed with particles; reaction forms agglutinates measured via rate nephelometry on Beckman Coulter IMMAGE® immunochemistry system. Concentration determined by interpolation of calibration curve. Used in clinical laboratory settings by trained personnel. Output provides B2M concentration levels to assist clinicians in diagnosing rheumatoid arthritis and kidney disease. ## Clinical Evidence Bench testing only. Precision evaluated using modified NCCLS EP10-A2 (total CV 3.8-5.3%). Linearity established from 0.5-20 mg/L (r=0.997). Method comparison with predicate (n=65) showed slope 1.17, intercept 0.70, r=0.997. Matrix comparison (serum vs EDTA/heparin plasma) showed high correlation (r > 0.996). No clinical sensitivity or specificity data provided. ## Technological Characteristics Microparticle immunoassay; polystyrene particles coupled with polyclonal rabbit anti-human B2M antibody. Detection via rate nephelometry. Energy source: IMMAGE® immunochemistry system. Reagents preserved with sodium azide. Calibration via internal reference material. Software: embedded instrument-specific processing. ## Regulatory Identification A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. ## Predicate Devices - IMx B2 Microglobulin ([K890421](/device/K890421.md)) ## 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} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE A. 510(k) Number: k032692 B. Analyte: Beta-2-Microglobulin C. Type of Test: Quantitative D. Applicant: DakoCytomation E. Proprietary and Established Names: DakoCytomation Beta-2-Microglobulin kit F. Regulatory Information: 1. Regulation section: 21 CFR §866.5630 2. Classification: Class II 3. Product Code: JZG 4. Panel: Immunology 82 G. Intended Use: 1. Intended use(s)/Indication for use (s): DakoCytomation Beta-2-Microglobulin kit is intended for quantitative determination of beta-2-Microglobulin in human serum and plasma by rate nephelometry on IMMAGE® immunochemistry systems. Measurement of Beta-2-microglobulin aids in the diagnosis of patients with active rheumatoid arthritis and kidney disease. Indication for use is the same as intended use. 2. Special condition for use statement(s): The device is for prescription use only 3. Special instrument Requirements: Beckman Coulter IMMAGE® {1} Page 2 of 5 # H. Device Description: The device is a microparticle immunoassay. Contains polystyrene particles of uniform size coupled with polyclonal rabbit antibody against human beta -2-microglobulin. A reaction between the immunoparticles with beta-2-microglobulin molecules in the patient specimen results in the formation of agglutinates. The instrument shows a response to this reaction. The beta-2-microglobulin concentration in the patient specimen is determined by interpolation of a calibration curve. The kit contains one 5ml of vial of polystyrene particles coupled with rabbit antibody against human beta-2-microglobulin preserved with 15 mmol/L sodium azide; calibrators 1-6 in buffer, pH 7.4 containing bovine serum albumin and preservative; high and low controls and reaction buffer. A value assignment sheet is provided. The range is established by each laboratory. The kit components should be stored at 2-8 degrees centigrade. # I. Substantial Equivalence Information: 1. Predicate device name(s): Abbott's IMx beta -2-microglobulin assay 2. Predicate K number(s): K890421 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | | DakoCytomation's β 2 M | Abbott's IMX β 2M | | Intended use/indication for usedication for use | Quantitative measurement of β 2 M as an aid in the diagnosis of rheumatoid arthritis and kidney disease | Same | | Differences | | | | Item | Device | Predicate | | Analyzer | Beckman Coulter IMMAGE® | Abbott's IMX® | | Matrix | Serum and heparinized or EDTA plasma | Serum, plasma and urine | | Method | Nephelometry | MEIA | | Antibody | Polyclonal | monoclonal | | Lower limit of detection | 0.3 mg/L | 0.05 mg/L | | Assay range | 0.3-20 mg/L | 0-40 mg/L | | Reference interval | 1.16-2.52 mg/L for age 20-50 1.42-3.21 mg/L for >50 years of age | < 1.9 mg/L | {2} Page 3 of 5 J. Standard/Guidance Document Referenced (if applicable): NCCLS EP10-A2 for precision K. Test Principle: Nephelometry L. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Total precision was determined using modified NCCLS EP 10-A2 (because of calibration stability claim). With the modified protocol 3 samples were mixed with repetition of the sequence to get a total of 6 determinations of each sample in each run. This was repeated 6 times with a calibration performed before each run, total of 36 determinations. | | | | Within run | | Total | | | --- | --- | --- | --- | --- | --- | --- | | Sample | data points | mean value | SD | CV | SD | CV | | Serum level 1 | 36 | 1.77mg/L | 0.084 | 4.7% | 0.094 | 5.3% | | Serum level 2 | 36 | 3.70 mg/L | 0.094 | 2.5% | 0.149 | 4.0% | | Serum level 3 | 36 | 7.19 mg/L | 0.194 | 2.7% | 0.275 | 3.8% | b. Linearity/assay reportable range: A serum pool was diluted with IMMAGE diluent 1 to get 6 concentrations of $\beta$ 2 microglobulin ranging from $1.1\mathrm{mg / L}$ to $17.3\mathrm{mg / L}$. Samples were tested in quadruplicate. A linear regression plot was generated. $\mathrm{Y} = 0.996\mathrm{X} + 0.21$; $\mathrm{r} = 0.997$. Measuring range $= 0.5 - 20\mathrm{mg / L}$. c. Traceability (controls, calibrators, or method): The assay is calibrated with an internal reference material, purified from samples obtained from patients with tubular proteinuria, in bovine serum albumin (stored frozen). For each new lot of product, the internal reference material is used for calibrator value assignment. d. Detection limit/functional sensitivity: The detection limit was estimated to be $0.3\mathrm{mg / L}$, taking the mean beta-2-M + 3 SD of 20 replicates of a zero standard. e. Analytical specificity: Not provided f. Assay cut-off: Not provided 2. Comparison studies: a. Method comparison with predicate device: {3} Page 4 of 5 Method comparison was assessed by Deming regression analysis. Samples concentrations ranged from 0.58 to 14.56 mg/L. Sixty-five serum samples were used. Five serum pools (2 different samples per pool) were prepared to provide high concentration samples. Seven samples were in-house samples of healthy adults and the remaining samples were anonymous surplus hospital samples with no patient information. It is not known whether multiple samples from the same patient are included. Serum and plasma samples were from in-house draws. Heparin and EDTA plasma samples were from 47 healthy adults. 38 paired samples were spiked with purified B2M at concentrations ranging from approximately 25 mg/L to 15 mg/L. The B2M recovery between DakoCytomation’s assay and Abbott’s assay is reflected in the reference intervals. The 95th percentile ranges are: Abbott’s B2M assay: <1.9 mg/L DakoCytomation’s B2M assay: 1.16-2.52 mg/L age 20-50 years 1.42-3.21 mg/L age > 50 years. Slope = 1.17 ± 0.02 (95% CI) and intercept = 0.70 ± 0.15 (95% CI). Mean for DakoCytomation’s assay is 6.40 mg/L and for the predicate is 4.87 mg/L. Correlation coefficient r = 0.9970 b. Matrix comparison: Test results of Beta 2 Microglobulin EDTA plasma (1.15 units) vs serum showed (Deming regression) Y = 1.04 X - 0.16; r = 0.997. Sodium heparin (14 units/mL) vs serum results: Y = 1.01 X + 0.01; r = 0.9968 Lithium heparin (14 units/mL) vs serum: y = 1.02 x - 0.07; r = 0.9981. (Serum = x and plasma = y). 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): None 4. Clinical cut-off: Not provided 5. Expected values/Reference range: 1.16-2.52 mg/L for 20-50 years of age 1.42-3.21 for over 50 years of age. {4} Page 5 of 5 ## M. Conclusion: DakoCytomation’s Beta 2 Microglobulin assay, intended for the quantitative determination of beta-2- microglobulin in human serum and plasma by rate nephrometry on IMMAGE® immunochemistry systems and indicated as an aid in the diagnosis of patients with active rheumatoid arthritis and kidney disease, is substantially equivalent to Abbott’s IMX® Beta 2 microglobulin assay with the same indication. --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K032692](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K032692) **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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