← Product Code [JZG](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG) · K072078 # QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 (K072078) _Biokit, S.A. · JZG · Dec 19, 2007 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K072078 ## Device Facts - **Applicant:** Biokit, S.A. - **Product Code:** [JZG](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG.md) - **Decision Date:** Dec 19, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5630 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglubulin concentration in human serum, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease. ## Device Story Quantia Beta-2 Microglobulin is a latex particle-enhanced immunoturbidimetric assay; utilizes polystyrene latex particles coated with rabbit IgG anti-human Beta-2-microglobulin. Device processes human serum, plasma (EDTA), or urine samples on the Abbott AEROSET instrument. When sample mixes with reagent, Beta-2-microglobulin causes agglutination; turbidity measured to quantify concentration. Used in clinical laboratory settings by trained personnel. Output provided in mg/L; aids clinicians in diagnosing active rheumatoid arthritis and kidney disease. Benefits include standardized quantitative assessment of renal function and inflammatory status. ## Clinical Evidence No clinical studies were performed. Analytical performance was established via bench testing, including precision (CLSI EP5-A), linearity (CLSI EP6-A), and interference testing (CLSI EP7-A). Method comparison study using 110 urine samples (range 0.01–18.85 mg/L) demonstrated a slope of 1.088 and correlation coefficient (r) of 0.9894 against the predicate device. ## Technological Characteristics Latex particle-enhanced immunoturbidimetric assay. Reagents: sodium dihydrogen phosphate dihydrate, polyethylene glycol, sodium azide, and polystyrene latex particles coated with rabbit IgG anti-human Beta-2-microglobulin. Dimensions/form factor: 4 bottles R1 (6 mL), 4 bottles R2 (3 mL). Energy source: optical turbidimetry via AEROSET instrument. Connectivity: instrument-specific. Sterilization: not applicable (reagent kit). ## 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 - IL Test Beta-2-Microglobulin ([K943686](/device/K943686.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} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k072078 B. Purpose for Submission: Addition of the urine matrix to the assay procedure C. Measurand: Beta-2-microglobulin D. Type of Test: Latex particle enhanced immunoturbidimetric assay E. Applicant: Biokit S.A. F. Proprietary and Established Names: Quantia Beta-2 Microglobulin G. Regulatory Information: | Product Code | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | System, Test, Beta-2-Microglobulin Immunological (JZG) | Class II | 21 CFR 866.5630, Beta-2-microglobulin immunological test system. | 82 IMMUNOLOGY (IM) | H. Intended Use: 1. Intended use(s): The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglobulin concentration in human serum, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease. The Quantia Beta-2 Microglobulin is intended to be used with the already cleared Quantia PROTEINS Control (k050596) and the Beta-2 Microglobulin Standard (k050613). 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: The reagents are for use on the Abbott AEROSET® instrument I. Device Description: The Quantia Beta-2 Microglobulin kit contains 4 bottles of Reagent 1 (R1) (6 mL each) and 4 bottles of Reagent 2 (R2) (3 mL each). R1 buffer is sodium dihydrogen {1} phosphate dihydrate with polyethylene glycol and preservative (sodium azide). R2 is a suspension of polystyrene latex particles of uniform size coated with the IgG fraction of rabbit anti-human Beta-2-microglobulin specific serum with preservative (sodium azide). J. Substantial Equivalence Information: | Predicate: IL Test Beta-2-Microglobulin | K943686 | | --- | --- | | | | | Similarities: | | | The Quantia Beta-2 Microglobulin and the IL Test Beta-2-Microglobulin are both manufactured by Biokit and are both intended for the quantitative in vitro diagnostic determination of beta-2-microglobulin. They also use the same methodology: Particle Enhanced Immunoturbidimetry. The Quantia Beta-2 Microglobulin and the IL Test Beta-2-Microglobulin, have the same composition: Latex Reagent Suspension of polystyrene latex particles coated with rabbit IgG anti-human Beta-2 Microglobulin in a buffer containing bovine serum albumin and < 0.1 % w/w sodium azide; and Reaction Buffer Phosphate buffer 40mM containing bovine serum albumin and sodium azide < 0.1 % w/w. | | | Differences: | | | Specimen type: both assays can use serum and urine as samples. They differ in the plasma types. The device can use EDTA and the predicate can use EDTA and sodium heparin. | | K. Standard/Guidance Document Referenced (if applicable): | STANDARDS | | --- | | Title and Reference Number | | CLSI Interference Testing in Clinical Chemistry; Approved Guideline (EP 7-A) | | CLSI Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP09-A2) | | CLSI Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline (EP5-A) | L. Test Principle: When a sample containing Beta-2 Microglobulin is mixed with the reagent, a clear agglutination occurs which can be measured by turbidimetry. Results are expressed in mg/L of Beta-2-microglobulin based on the 1st WHO International Standard (B2M) established in 1985. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: CLSI EP5-A was followed. {2} | Samples/Runs | Mean (mg/L) | CV (%) Within Run | CV (%) Total | | --- | --- | --- | --- | | 2/40 | 0.066 | 4.2 | 5.4 | | 2/40 | 0.094 | 1.7 | 3.1 | | 2/40 | 0.204 | 1.5 | 2.6 | | 2/40 | 0.302 | 1.6 | 2.3 | b. Linearity/assay reportable range: Linearity was assessed according to CLSI EP6-A. The overall reportable range for serum, plasma and urine is 0.025 to 96 mg/L. The assay was linear from 0.025 to 1.6 mg/L (the reportable range for urine samples) with the automatic rerun capability (Dilution Protocol 2); from 0.25 to 16 mg/L without the automatic rerun capability; and from 16 to 96 mg/L with the automatic rerun capability (Dilution Protocol 1). Prozone The manufacturer was asked to run a sample higher than 114 mg/L to demonstrate the instrument give a result of >16 mg/L. They tested samples from 80.4 to 200.9 mg/L. In all cases the instrument gave a result of >96 (serum linearity upper limit) and triggered the Dilution Protocol 1. The assay did not demonstrate prozone effect with specimens up to 200 mg/L. c. Traceability, Stability, Expected values (controls, calibrators, or methods): The assay calibrators are standardized against WHO reference material B2M. Stability of the reagents was established at 19 months by testing 4 different lots. Reagents should be stored at 2-8°C. d. Detection limit: The limit of quantitation (LOQ) was defined as the minimum quantity of analyte that can be measured with a within-run CV below 20% and an error below 20%. The LOQ for the assay was determined to be 0.25 mg/L without the automatic rerun capability and 0.025 mg/L with the automatic rerun capability for serum, plasma and urine. This was established by running serial dilutions of the 4 mg/L calibrator. Through 0.025 mg/L the %CV ranged from 1.0 to 5.5% and error ranged from 3.8 to 9.3%. The limit of detection (LOD) was defined as the mean reported value + 2SD for a sample free of analyte. The LOD was determined to be 0.046 mg/L without the rerun capability and 0.025 mg/L (LOQ) with the automatic rerun capability. e. Analytical specificity: CLSI guideline EP7-A was followed. | Substance tested | Concentration (mg/dL) | Outcome | | --- | --- | --- | | Conjugated bilirubin | 20.9 | No interference | | Ascorbic acid | 20 | Interference below 10% | | Hemoglobin | 23.6 | Interference below 10% | | Protein (IgG) | 100 | No interference | Urine pH showed no significant positive or negative influence on the result. {3} f. Assay cut-off: See Expected values/Reference range 2. Comparison studies: a. Method comparison with predicate device: The comparison studies were performed using 110 urine samples with values ranging from 0.01 to 18.85 mg/L. The required specifications were: Slope 1.0 ± 0.20; and correlation coefficient r ≥ 0.950. The following results were obtained: AEROSET versus ILab 900 | Parameter | Outcome | | --- | --- | | Slope | 1.088 (95% CI: 1.061 to 1.127) | | Intercept | -0.001 (95% CI: -0.003 to 0.002) | | Range (mg/L) | 0.01- 18.85 | | Mean x (mg/L) | 2.47 | | Mean y (mg/L) | 2.467 | | R | 0.9894 | b. Matrix comparison: Urine was the only matrix compared. 3. Clinical studies: a. Clinical Sensitivity: Not determined b. Clinical specificity: Not determined c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not determined 5. Expected values/Reference range: Concentrations of Beta-2-microglobulin in urine from healthy subjects averaged 0.098 mg/L with an upper normal limit of 0.32 mg/L (literature). 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 substantially equivalent decision. --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K072078](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K072078) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com