← Product Code [SEI](/submissions/MI/subpart-d%E2%80%94serological-reagents/SEI) · K260049 # Elecsys Anti-HBc IgM (K260049) _Roche Diagnostics · SEI · Apr 7, 2026 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SEI/K260049 ## Device Facts - **Applicant:** Roche Diagnostics - **Product Code:** [SEI](/submissions/MI/subpart-d%E2%80%94serological-reagents/SEI.md) - **Decision Date:** Apr 7, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3173 - **Device Class:** Class 2 - **Review Panel:** Microbiology - **Attributes:** Pediatric ## Indications for Use Immunoassay for the in vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) from adult and pediatric (2 through 21 years of age) patients with symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis B virus (HBV) infection. The immunoassay’s performance has not been established for the monitoring of HBV disease or therapy. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e immunoassay analyzers. ## Device Story Qualitative electrochemiluminescence immunoassay (ECLIA) for detection of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum/plasma. Sample incubated with biotinylated monoclonal h-IgM-specific antibodies and ruthenium-labeled HBcAg; streptavidin-coated microparticles capture immune complexes. Microparticles magnetically captured on electrode; voltage application induces chemiluminescence measured by photomultiplier. Used on cobas e immunoassay analyzers in clinical laboratory settings. Results expressed as cutoff indices (COIs) compared against calibration values. Assists clinicians in diagnosing acute/recent HBV infection when combined with other clinical data. Benefits include standardized, automated detection of HBV-specific IgM antibodies in pediatric and adult populations. ## Clinical Evidence Prospective study of 119 pediatric participants (ages 2-21) showed 100% negative percent agreement (NPA) (95% CI: 96.9-100). No positive specimens identified in prospective cohort. Spiking study using 30 pediatric and 30 adult serum samples confirmed performance consistency, with percent difference in index values ≤±12%. ## Technological Characteristics Qualitative μ-capture ECLIA. Uses biotinylated monoclonal antibodies, ruthenium-labeled HBcAg, and streptavidin-coated microparticles. Energy source: electrical voltage for chemiluminescence induction. Platform: cobas e immunoassay analyzers. Automated specimen handling and barcode identification. Software-based result calculation via COI comparison. ## Regulatory Identification A hepatitis B virus (HBV) antibody assay is identified as an in vitro diagnostic device intended for prescription use in the detection of antibodies to HBV in human serum, plasma, or other matrices, and as a device that aids in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis B infection. Results from assays may be qualitative or quantitative, such as quantitative anti-HBs. In addition, results from an anti-HBc IgM (IgM antibodies to core antigen) assay indicating the presence of anti-HBc IgM are indicative of recent HBV infection. Anti-HBs (antibodies to surface antigen) assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown. The assay is not intended for screening of blood, plasma, cells, or tissue donors. The assay is intended as an aid in diagnosis in conjunction with clinical findings and other diagnostic procedures. ## Special Controls *Classification.* Class II (special controls). The special controls for this device are:(1) The labeling required under § 809.10(b) of this chapter must include: (i) A prominent statement that the assay is not intended for the screening of blood, plasma, cells, or tissue donors. (ii) A detailed explanation of the principles of operation and procedures for performing the assay. (iii) A detailed explanation of the interpretation of results. (iv) Limitations, which must be updated to reflect current clinical practice and disease presentation and management. The limitations must include statements that indicate: (A) When appropriate, performance characteristics of the assay have not been established in populations of immunocompromised or immunosuppressed patients or other special populations where assay performance may be affected. (B) Detection of HBV antibodies to a single viral antigen indicates a present or past infection with hepatitis B virus, but does not differentiate between acute, chronic, or resolved infection. (C) The specimen types for which the device has been cleared, and that use of the assay with specimen types other than those specifically cleared for this device may result in inaccurate assay results. (D) Diagnosis of hepatitis B infection should not be established on the basis of a single assay result but should be determined by a licensed healthcare professional in conjunction with the clinical presentation, history, and other diagnostic procedures. (E) A non-reactive assay result may occur early during acute infection, prior to development of a host antibody response to infection, or when analyte levels are below the limit of detection of the assay. (F) Results obtained with this assay may not be used interchangeably with results obtained with a different manufacturer's assay. (v) For devices intended for the quantitative detection of HBV antibodies (anti-HBs), in addition to the special controls listed in paragraphs (b)(1) and (2) of this section, labeling required under § 809.10(b) of this chapter must include: (A) The assay calibrators' traceability to a standardized reference material that FDA has determined is appropriate ( *e.g.,* a recognized consensus standard) and the limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ), linearity, and precision to define the analytical measuring interval.(B) Performance results of the analytical sensitivity study testing a standardized reference material that FDA has determined is appropriate ( *e.g.,* a recognized consensus standard).(2) Design verification and validation must include the following: (i) Detailed device description, including all parts that make up the device, ancillary reagents required but not provided, an explanation of the device methodology, and design of the antigen(s) and capture antibody(ies) sequences, rationale for the selected epitope(s), degree of amino acid sequence conservation of the target, and the design and composition of all primary, secondary and subsequent standards used for calibration. (ii) Documentation and characterization ( *e.g.,* supplier, determination of identity, and stability) of all critical reagents (including description of the antigen(s) and capture antibody(ies)), and protocols for maintaining product integrity throughout its labeled shelf life.(iii) Risk analysis and management strategies, such as Failure Modes Effects Analysis and/or Hazard Analysis and Critical Control Points summaries and their impact on assay performance. (iv) Final release criteria to be used for manufactured assay lots with appropriate evidence that lots released at the extremes of the specifications will meet the identified analytical and clinical performance characteristics as well as stability. (v) Stability studies for reagents must include documentation of an assessment of real-time stability for multiple reagent lots using the indicated specimen types and must use acceptance criteria that ensure that analytical and clinical performance characteristics are met when stability is assigned based on the extremes of the acceptance range. (vi) All stability protocols, including acceptance criteria. (vii) When applicable, analytical sensitivity of the assay that is the same or better than that of other cleared or approved assays. (viii) Analytical performance studies and results for determining the limit of blank (LoB), limit of detection (LoD), cutoff, precision (reproducibility), including lot-to-lot and/or instrument-to-instrument precision, interference, cross reactivity, carryover, hook effect, seroconversion panel testing, matrix equivalency, specimen stability, reagent stability, and cross-genotype antibody detection sensitivity, when appropriate. (ix) For devices intended for the detection of antibodies for which a standardized reference material (that FDA has determined is appropriate) is available, the analytical sensitivity study and results testing the standardized reference material. Detailed documentation of that study and its results must be provided, including the study protocol, study report, testing results, and all statistical analyses. (x) For devices with associated software or instrumentation, documentation must include a detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review. (xi) Detailed documentation of clinical performance testing from a clinical study with an appropriate number of HBV reactive and non-reactive samples in applicable risk categories and conducted in the appropriate settings by the intended users. Performance must be analyzed relative to an FDA cleared or approved HBV antibody assay or a comparator that FDA has determined is appropriate. Additional relevant patient groups must be validated as appropriate. The samples must include prospective (sequential) samples for each identified specimen type and, as appropriate, additional characterized clinical samples. Samples must be sourced from geographically diverse areas. (3) For any HBV antibody assay intended for quantitative detection of anti-HBV antibodies, the following special controls, in addition to those special controls listed in paragraphs (b)(1) and (2) of this section, also apply: (i) Detailed documentation of the metrological calibration traceability hierarchy to a standardized reference material that FDA has determined is appropriate. (ii) Detailed documentation of the following analytical performance studies conducted, as appropriate to the technology, specimen types tested, and intended use of the device, including upper and lower limits of quantitation (UloQ and LloQ, respectively), linearity using clinical samples, and an accuracy study using the recognized international standard material. ## Predicate Devices - Abbott ARCHITECT CORE-M ([P060035](/device/P060035.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} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT ## I Background Information: A 510(k) Number K260049 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys Anti-HBc IgM D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | SEI | Class II | 21 CFR 866.3173 Hepatitis B virus antibody assay | MI - Microbiology | ## II Submission/Device Overview: A Purpose for Submission: Addition of pediatric (2 through 21 years of age) population to the indications for use. B Measurand: IgM antibodies to hepatitis B core antigen (anti-HBc IgM) C Type of Test: Qualitative electrochemiluminescence immunoassay (ECLIA) ## III Intended Use/Indications for Use: Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} K260049 - Page 2 of 8 A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) from adult and pediatric (2 through 21 years of age) patients with symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis B virus (HBV) infection. The immunoassay’s performance has not been established for the monitoring of HBV disease or therapy. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e immunoassay analyzers. C Special Conditions for Use Statement(s): Rx – For Prescription Use Only D Special Instrument Requirements: For use with the cobas e immunoassay analyzers. IV Device/System Characteristics: A Device Description: The Elecsys Anti-HBc IgM immunoassay is a qualitative, serologic, μ-capture assay. The sample is incubated with biotinylated monoclonal h-IgM-specific antibodies and then with HBcAg labeled with ruthenium. Streptavidin-coated microparticles are subsequently added to capture the immune complexes. The biotinylated antibodies and ruthenium-labeled antigen form a sandwich complex with the anti-HBc IgM antibodies present in the sample. This complex then binds to the solid phase through the interaction between biotin and streptavidin. The microparticles are magnetically captured on the surface of an electrode and unbound substances are removed in a washing step. Application of a voltage to the electrode induces chemiluminescence, which is measured by a photomultiplier. Results are determined automatically by comparing the signal obtained from the sample with the signal of the cut-off value previously obtained by anti-HBc IgM calibration. Results are expressed as cutoff indices (COIs). The Elecsys Anti-HBc IgM is intended to be used with the following calibrators and controls: - AHBCIGM Cal1 and AHBCIGM Cal2 - PreciControl Anti-HBc IgM B Principle of Operation: The Elecsys Anti-HBc IgM immunoassay employs electrochemiluminescence technology and is a qualitative serological, μ-capture assay. Total duration of the assay is 18 minutes. - 1st incubation: Pretreatment of 6 μL of sample (automatically prediluted 1:400 with Diluent Universal) with anti Fdγ reagent to block specific IgG. {2} - 2nd incubation: Biotinylated monoclonal h IgM specific antibodies, HBcAg labeled with a ruthenium complex $^{a)}$ and streptavidin-coated microparticles are added to the pretreated sample. Anti HBc IgM antibodies present in the sample react with the ruthenium labeled HBcAg and the biotinylated anti h IgM to form a sandwich complex which becomes bound to the solid phase via interaction of biotin and streptavidin. - The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. - Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration. a) Tris (2,2' bipyridyl) ruthenium (II) complex (Ru(bpy)) Interpretation of results: | Initial Elecsys Anti-HBc IgM assay results | | | | | --- | --- | --- | --- | | COI | Result | Interpretation of results | Retest procedure | | < 0.9 | Non-reactiveA) | No IgM antibodies to HBc were detected | No retest required | | 0.9 ≤ COI < 1.1 | Border | Borderline zone (undetermined) | Retest in duplicate with the Elecsys Anti-HBc IgM assay | | ≥ 1.1 | Reactive | IgM antibodies to HBc detected | Presumptive evidence of IgM antibodies to HBc. Follow CDC recommendations for ancillary testing. No retest required. | A) Please note: A negative anti-HBc IgM result can indicate that the patient is either susceptible to HBV infection due to no past exposure, is chronically infected with HBV, or is immune to HBV infection due to a resolved past infection or vaccination. | Final Elecsys Anti-HBc IgM assay results | | | | | --- | --- | --- | --- | | Initial result (COI) | Result after retest (COI) | Final results | Interpretation of results | | < 0.9 | No retest required | NON-REACTIVEA) | IgM antibodies to HBc were not detected; does not exclude the possibility of exposure to HBV | | 0.9 ≤ COI < 1.1 | If 2 of the 3 results have a COI < 1.0 | NON-REACTIVE | IgM antibodies to HBc were not detected; does not exclude the possibility of exposure to HBV | | | If 2 of the 3 results have a COI ≥ 1.0 | REACTIVE | Presumptive evidence of IgM antibodies to HBc. Follow CDC recommendations for ancillary testing. | | ≥ 1.1 | No retest required | REACTIVE | Presumptive evidence of IgM antibodies to HBc. Follow CDC recommendations for ancillary testing. | A) Please note: A negative anti-HBc IgM result can indicate that the patient is either susceptible to HBV infection due to no past exposure, is chronically infected with HBV, or is immune to HBV infection due to a resolved past infection or vaccination. K260049 - Page 3 of 8 {3} K260049 - Page 4 of 8 C Instrument Description Information: 1. Instrument Name: cobas e immunoassay analyzer. 2. Specimen Identification: Automated specimen identification using barcode scanning by the instrument. 3. Specimen Sampling and Handling: Specimen sampling and handling is fully automated on the instrument. 4. Calibration: Elecsys Anti-HBc IgM reagent components contain calibrators AHBCIGM Cal1 and AHBCIGM Cal2. 5. Quality Control: The Elecsys Anti-HBc IgM assay uses PreciControl Anti-HBc IgM for quality control. The controls 1(negative) and 2(positive), contain human serum in the negative and positive concentration ranges for anti-HBc IgM. V Substantial Equivalence Information: A Predicate Device Name(s): Abbott ARCHITECT CORE-M assay B Predicate 510(k) Number(s): P060035 C Comparison with Predicate(s): | Device & Predicate Device(s): | K260049 | P060035 | | --- | --- | --- | | Device Trade Name | Elecsys Anti-HBc IgM | Abbott ARCHITECT CORE-M | | General Device Characteristic Similarities | | | | Regulation No./Product Code | 21 CFR 866.3173/SEI | Same | | Regulation Name | Hepatitis B virus Antibody assays | Same | | Device Class | Class II | Class III | | Intended Use/Indications For Use | Immunoassay for the in vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti HBc | The ARCHITECT CORE-M assay is a chemiluminescent microparticle immunoassay (CMIA) | {4} K260049 - Page 5 of 8 | | IgM) in human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) from adult and pediatric (2 through 21 years of age) patients with symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The presence of anti HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis B virus (HBV) infection. The immunoassay's performance has not been established for the monitoring of HBV disease or therapy. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. | used for the qualitative detection of IgM antibody to hepatitis B core antigen (IgM anti-HBc) in human adult and pediatric serum or plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum on the ARCHITECT i System. The ARCHITECT CORE-M assay is to be used as an aid in the diagnosis of acute or recent hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information. | | --- | --- | --- | | Analyte Measured | Anti-HBc IgM | Same | | Test Principle | μ Capture test principle | Two-step immunoassay | | **General Device Characteristic Differences** | | | | Sample Type/Matrix | Serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) | Serum or plasma (dipotassium EDTA, lithium heparin, and sodium heparin) | | Calibrator | AHBCIGM Cal1 AHBCIGM Cal2 | ARCHITECT CORE-M Calibrators | | Controls | PreciControl Anti-HBc IgM | ARCHITECT CORE-M Controls | | Instrument Platform | Cobas e immunoassay analyzers | ARCHITECT i System | {5} VI Standards/Guidance Documents Referenced: CLSI EP05-A3: Clinical Laboratory Standards Institute. Evaluation of the Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. CLSI Guideline EP05-A3, CLSI: Wayne, PA, 2014. VII Performance Characteristics (if/when applicable): A Analytical Performance: 1. Precision/Reproducibility: See P110022. 2. Linearity: Not applicable. 3. Analytical Specificity/Interference: See P110022. 4. Detection Limit and Assay Reportable Range: Not applicable. 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): See P110022. 6. Assay Cut-Off: See P110022. B Comparison Studies: 1. Method Comparison with Predicate Device: Not applicable. See Clinical Studies below. 2. Matrix Comparison: See P110022. C Clinical Studies: 1. Clinical Sensitivity: Not Applicable. K260049 - Page 6 of 8 {6} 2. Clinical Specificity: Not Applicable. 3. Clinical Cut-Off: Not Applicable. 4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): Performance characteristics of the Elecsys Anti-HBc IgM assay in pediatric population were established with prospective and spiking studies. For the prospective study, serum samples were collected from 119 Pediatric participants (age 2 through 21 years) who presented with signs and symptoms of hepatitis or who may be at risk for HBV infection. The age distribution of the study was as follows: 31.9% (n=38) of study participants were 2-11 years old and 68.1% (n=81) were 12-21 years old. These samples were tested using the Elecsys Anti-HBc IgM assay and the results were used to calculate the percent agreement and confidence interval relative to the comparator device (Table 1-2). Table 1. Prospective pediatric study results for Elecsys Anti-HBc IgM assay. | Elecsys Anti-HBc IgM | Comparator | | | | --- | --- | --- | --- | | | Reactive | Grayzone | Nonreactive | | Reactive | 0 | 0 | 0 | | Nonreactive | 0 | 0 | 119 | | Total | 0 | 0 | 119 | Table 2. Percent agreements with confidence intervals (CI) | Age range (years) | PPA | | NPA | | | --- | --- | --- | --- | --- | | | % (n/N) | 95% CI | % (n/N) | 95% CI | | 2-11 | NA (0/0) | NA | 100 (38/38) | 90.6-100 | | 12-21 | NA (0/0) | NA | 100 (81/81) | 95.4-100 | | Total | NA | NA | 100 (119/119) | 96.9-100 | Because no positives specimens were identified in the prospective study, a spiking study was conducted to evaluate the performance of the Elecsys Anti-HBc IgM assay using 30 pediatric (age 2 through 21 years) and 30 adult (>22 years of age) serum samples spiked with anti-HBc IgM positive samples. Percent difference between the index values of pediatric (spiked) and adult (spiked) samples were calculated. The percent difference between the pediatric and adult samples was ≤±12%. D Expected Values/Reference Range: See P110022. K260049 - Page 7 of 8 {7} VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K260049 - Page 8 of 8 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SEI/K260049](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SEI/K260049) **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