← Product Code [CFF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF) · K082388 # MINICAP IMMUNOTYPING, MODEL: 2300 (K082388) _Sebia · CFF · Apr 14, 2009 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K082388 ## Device Facts - **Applicant:** Sebia - **Product Code:** [CFF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF.md) - **Decision Date:** Apr 14, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5510 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Intended Use The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP System, SEBIA, for capillary electrophoresis. It is used in conjunction with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The MINICAP performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (lg G), aipha (Iq A) and mu (Ig M) heavy chains, and kappa and lambda (free and bound) light chains, respectively. The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm. The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspected monoclonal proteins. For In Vitro Diagnostic Use. ## Device Story MINICAP IMMUNOTYPING is an in vitro diagnostic kit for identifying monoclonal proteins in human serum. It utilizes capillary zone electrophoresis on the SEBIA MINICAP System. The process involves mixing serum samples with specific antisera (IgG, IgA, IgM, Kappa, Lambda) and an ELP solution. The system automatically performs sample dilution, injection into silica capillaries, and high-voltage protein separation in an alkaline buffer (pH 9.9). Proteins are detected via absorbance at 200 nm. The system generates electrophoregrams; clinicians visually compare antisera patterns against a reference ELP pattern. Disappearance or decrease of a monoclonal fraction in the presence of specific antisera indicates a gammopathy. The device is intended for clinical laboratory use, providing automated, qualitative analysis to assist in diagnosing monoclonal gammopathies. ## Clinical Evidence Bench testing only. Analytical performance included precision/reproducibility studies using normal and pathological serum samples (IgG, IgA, IgM), confirming concordant results across different reagent lots. Detection limit is 25 mg/dL. Interference testing showed no effect from hemoglobin, cholesterol, or triglycerides. Method comparison study (n=69) against the predicate device demonstrated 100% qualitative agreement. ## Technological Characteristics Capillary zone electrophoresis system using silica capillaries. Reagents include specific antisera for IgG, IgA, IgM, Kappa, and Lambda. Detection via 200 nm absorbance. Operates in alkaline buffer (pH 9.9). Automated sample dilution and loading. System uses 2 parallel capillaries. Software-controlled automation for barcode reading, dilution, and analysis. ## 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 ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k082388 B. Purpose for Submission: New device C. Measurand: Monoclonal Immunoglobulins (IgG, IgA, IgM, Kappa, Lambda) in serum D. Type of Test: Capillary Zone Electrophoresis E. Applicant: SEBIA, INC. F. Proprietary and Established Names: MINICAP IMMUNOTYPING (PN 2300) G. Regulatory Information: 1. Regulation section: 21 CFR § 866.5510 Immunoglobulins (A, G, M, D, E) Immunological Test Systems 21 CFR § 866.5550 Immunoglobulin (light chain specific) Immunological Test 21 CFR § 862.1630 Electrophoretic, Protein Fractionation 2. Classification: Class II 3. Product code: CFF - Immunoelectrophoretic, Immunoglobulins (G, A, M) DFH – Kappa, Antigen, Antiserum, Control DEH – Lambda, Antigen, Antiserum, Control CEF – Electrophoretic, Protein Fractionation 4. Panel: Immunology (82) Clinical Chemistry (75) H. Intended Use: 1. Intended use: The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP System, SEBIA, for capillary electrophoresis. It is used in conjunction with the MINICAP PROTEIN (E) 6 kit, SEBIA, designed for serum proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The MINICAP system performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa and lambda (free and bound) light chains respectively. The proteins, separated in silica capillaries, are directly detected by their absorbance at {1} 200 nm. The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspected monoclonal proteins. For in vitro diagnostic use only. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): The device is for prescription use only. 4. Special instrument requirements: This device has been validated for use with the SEBIA MINICAP System (capillary electrophoresis) which was cleared in k082227. # I. Device Description: The MINICAP IMMUNOTYPING kit (PN 2300) kit contains seven ready to use components: sample diluent supplied in 6 vials, $4\mathrm{mL}$ each; ELP Solution supplied in 1 vial, $1.2\mathrm{mL}$ ; and 5 antisera tubes with specific antibodies against gamma (IgG), alpha (IgA) mu (IgM) heavy chains and kappa (free and bound) light chains, and lambda (free and bound) light chains, supplied in 1 tube, $1.2\mathrm{mL}$ each. # J. Substantial Equivalence Information: 1. Predicate device name(s): CAPILLARYS IMMUNOTYPING, PN 2100 2. Predicate 510(k) number(s): k042939 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Intended Use | For the detection and the characterization of monoclonal proteins (immunotyping) in human serum | Same | | Methodology | Capillary electrophoresis | Same | | Technology | SIFE/s: Capillary Electrophoretic Migration with Immunofixation by Subtraction (Immunotyping). | Same | | Absorbance wave length | 200 nm | Same | | Sample type | Serum | Same | | Introduction of the sample into the automatic system | Continuous loading | Same | | Sample identification | Yes | Same | | Antisera Specificity | Antibody specificity to heavy chains (IgG, IgA, IgM) and to light chains (Kappa, Lambda). | Same | | Antisera Storage | 2 – 8°C | Same | | Buffer pH | pH 9.9 | Same | {2} | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Lowest detectible Limit | 25 mg/dL | Same | | Results | Qualitative Interpretation | Same | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Instrument | MINICAP System | CAPILLARYS System | | Number of separation units | 2 parallel capillaries | 6 parallel capillaries | | Number of analysis (throughput) | 2 samples/hour | 8 samples/hour | | Immunotyping antisera | Antisera tubes | Antisera segments | | Buffer reagent | 2 vials of 250 mL | 2 vials of 700 mL | | Wash solution | 1 vial of 25 mL Stock solution | 1 vial of 75 mL Stock solution | | Serum sample volume required for dilution: dependent on immunoglobulin concentration) | <0.8 g/dL Ig: 30 μL of serum required to make 1:10 dilution | <0.8 g/dL Ig: 40 μL of serum required to make 1:10 dilution | | | 0.8-2.0g/dL Ig: 15 μL of serum to make 1:20 dilution; and | 0.8-2.0g/dL Ig: 20 μL of serum to make 1:20 dilution; and | | | >2.0g/dL Ig: 10 μL of serum to make 1:40 dilution | >2.0g/dL Ig: 20 μL of serum to make 1:40 dilution | # K. Standard/Guidance Document Referenced (if applicable): Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 11, 2005. # L. Test Principle: Protein electrophoresis is a well established technique routinely used in clinical laboratories for screening serum samples for protein abnormalities. The MINICAP System, SEBIA, for capillary electrophoresis has been developed to provide complete automation of this testing with fast separation and good resolution. In many aspects, the methodology can be considered as an intermediary between classical zone electrophoresis and liquid chromatography. The MINICAP System uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation also occurs according to the electrolyte pH and electroosmotic flow. In capillary electrophoresis, abnormal fractions in serum protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones, are always suspected {3} of being monoclonal proteins (M-proteins, paraproteins, monoclonal immunoglobulins) and therefore, an indication of monoclonal gammopathies. With MINICAP IMMUNOTYPING procedure, the immunotyping is performed with specific antibodies to identify these abnormal fractions. The MINICAP system has 2 capillaries functioning in parallel. In this system, a sample dilution is prepared and injected simultaneously by aspiration at the anodic end of the 2 capillaries, 3 times successively. For the immunotyping, the reference pattern (ELP pattern) is obtained by injection of the sample mixed with ELP solution in a capillary providing a complete electrophoretic pattern of sample proteins. The antisera patterns are obtained with the 5 following analyses, by injection in capillaries of the previously diluted samples mixed with specific antisera against gamma (Ig G), alpha (Ig A), mu (Ig M) heavy chains, and against free and bound Kappa and Lambda light chains. A high voltage protein separation is then performed and direct detection of the proteins is made at 200 nm at the cathodic end of the capillary. The capillaries are immediately washed with a Wash Solution and prepared for the next analysis with buffer. The superimposition of the antisera patterns with the ELP pattern allows for visualization of the disappearance and / or the decrease of a monoclonal fraction on the antiserum pattern and to indicate a gammopathy. NOTE: In MINICAP IMMUNOTYPING procedure, proteins are detected in the following order from cathode to anode: gamma globulins, beta-2 globulins, beta-1 globulins, alpha-2 globulins, alpha-1 globulins and albumin with each zone containing one or more proteins. The antigen - antibody complex (between the serum sample immunoglobulins and the specific antiserum) has a very anodic mobility (between alpha-1 zone and albumin or more anodic than albumin). M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Study Design: Within run reproducibility - Four serum samples were run 6 times within a run and the run was repeated with a different lot number antiserum. The four samples were comprised of one normal sample and three pathological samples: monoclonal IgG Lambda, IgA Kappa, and IgM Kappa. According to the identified monoclonal protein, the concordant and reproducible within-run results were obtained. Between run reproducibility - Three serum samples were run 4 times and repeated in 3 runs on 3 different lot number antisera. The three samples were comprised of one IgG Kappa, one IgM Kappa and one IgA Lambda (with two monoclonal components) and had a total Ig levels between 0.8 g/dL to 2 g/dL. According to the identified monoclonal component characterization, the concordant and reproducible between-run results were obtained. 4 {4} b. Linearity/assay reportable range: Not applicable. c. Traceability, Stability, Expected values (controls, calibrators, or methods): No reference standards and method available. d. Detection limit: MINICAP IMMUNOTYPING detection limit results are listed below: | Sample No. | Monoclonal component | | | Detection limit (mg/dL) | | --- | --- | --- | --- | --- | | | Type | | Concentration (g/dL) (in the original serum) | | | 1 | Ig A, L | Alpha | 2.7 | 25 | | | | Lambda | | 25 | | 2 | Ig G, K | Gamma | 2.9 | 25 | | | | Kappa | | 25 | | 3 | Ig M, K | Mu | 1.7 | 25 | | | | Kappa | | 25 | The detection limit of a monoclonal component is about $25\mathrm{mg / dL}$ e. Analytical specificity: Interference by endogenous substances: Seven samples comprised of one normal and six pathological sera (IgGκ, IgGλ, IgAκ, IgAλ IgMκ, IgMλ) were spiked with endogenous substances namely hemoglobin, total cholesterol and total triglyceride and tested on MINICAP Immunotyping device. No effects were observed with hemoglobin (up to 4 g/L), total cholesterol (up to 3.17 g/L) and total triglyceride (up to 10.16 g/L). The package insert states to avoid aged improperly stored serum samples, beta fractions would be modified and to avoid plasma samples, fibrinogen migrates in beta-2 position (shoulder on beta-2); interferences due to bilirubin have not been studied for the MINICAP IMMUNOTYPING PROCEDURE; it is advised to observe the serum sample features; when an interferent fraction is suspected, it is recommended to perform again the analysis on the serum sample or to use complementary studies with other techniques. f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: Study design: A total of 69 serum samples (57 pathological and 12 normal) were performed on MINICAP IMMUNOTYPING using the MINICAP System and on the CAPILLARYS IMMUNOTYPING kits using the CAPILLARYS System. The study demonstrated $100\%$ agreement between the two methods (see results below). {5} | Qualitative Results | Total | Complete Agreement | | --- | --- | --- | | Normal | 12 | 12 | | IgG κ | 23 | 23 | | IgG κ + 2 κ (not GAM) | 1 | 1 | | IgG λ | 15 | 15 | | IgA κ | 5 | 5 | | IgA κ (Biclonal) | 3 | 3 | | IgA κ (Biclonal) | 2 | 2 | | IgM κ | 6 | 6 | | IgM λ | 1 | 1 | | IgM λ + 2 IgM λ | 1 | 1 | | Grand Total | 69 | 69 | b. Matrix comparison: Not applicable. 3. Clinical studies: a. Clinical Sensitivity: Not given. b. Clinical specificity: Not given. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Same as Expected values/Reference range. 5. Expected values/Reference range: Absence of monoclonal immunoglobulins. N. Instrument Name: MINICAP System, SEBIA PN 1230 O. System Descriptions: 1. Modes of Operation: Batch mode with the following sequence of automated steps: Bar code reading of serum sample tubes (up to 18), reagent tubes and rotating sampler Sample dilution from primary tubes in reagent cups Capillary washing Injection of diluted samples Protein separation and direct detection of the separated proteins on capillaries 2. Software: The SEBIA MINICAP operating system software is designed to work with the instrumentation, MINICAP. The MINICAP instrumentation directed by the PHORESIS software is fully automated in the performance of the sample identification by barcode labelling, dilution, testing, and calculation of results. The PHORESIS software utilizes Windows 98 or XP as the operating system with {6} Intel based processors with Visual Basic as the programming language. FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☐ X or No ☐ 3. Specimen Identification: Bar Code Reader 3. Specimen Sampling and Handling: Fresh serum samples are recommended for analysis. Samples may be stored for up to 10 days between 2 and 8°C. For longer storage, samples should be frozen within 8 hours of collection. Frozen sera are stable for one month. Undiluted serum samples from primary tubes are automatically diluted according to the Immunoglobulin (Ig) concentration: 1:10 dilution on <0.8 g/dL Ig using 30 μL of serum to make dilution; 1:20 dilution on 0.8-2.0 g/dL using 15 μL of serum; and 1:40 dilution on >2.0 g/dL using 10 μL of serum. 5. Calibration: Not applicable. 6. Quality Control: It is necessary to use the ELP solution as the reference electrophoretic pattern of the sample proteins. Superimposition of the antisera patterns with the ELP pattern allows for visualization of the disappearance and/or the decrease of a monoclonal fraction of the antiserum pattern and to indicate a gammopathy. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: None. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 7 --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K082388](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFF/K082388) **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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