Elecsys Anti-HAV IgM

K260048 · Roche Diagnostics · LOL · Apr 7, 2026 · Microbiology

Device Facts

• Record ID: K260048
• Device Name: Elecsys Anti-HAV IgM
• Applicant: Roche Diagnostics
• Product Code: LOL · Microbiology
• Decision Date: Apr 7, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3310
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) from adult and pediatric (2 to 21 years of age) patients with signs and symptoms of hepatitis or persons who may be at risk for hepatitis A infection. The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus (HAV) infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HAV. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

Device Story

Elecsys Anti-HAV IgM is a qualitative electrochemiluminescence immunoassay (ECLIA) for detecting IgM antibodies to HAV in human serum/plasma. Used on cobas e immunoassay analyzers in clinical laboratories. Principle: μ-capture immunoassay; sample pretreated to block IgG; biotinylated monoclonal h-IgM-specific antibodies, HAV antigen, and ruthenium-labeled anti-HAV antibody form sandwich complex; complexes captured on streptavidin-coated magnetic microparticles; voltage applied to electrode triggers chemiluminescent emission measured by photomultiplier. Results calculated automatically by comparing sample signal to calibrated cutoff. Aids clinicians in diagnosing acute/recent HAV infection when combined with other clinical data.

Clinical Evidence

Clinical performance evaluated in 123 pediatric subjects; 100% negative percent agreement (95% CI: 97.0-100). Positive percent agreement not applicable due to zero reactive samples in cohort. Supplemental study using 30 spiked pediatric samples confirmed performance equivalence to adult samples (percent difference ≤ 20%).

Technological Characteristics

Qualitative μ-capture ECLIA; utilizes biotin-streptavidin magnetic microparticle capture; ruthenium-labeled monoclonal antibody; chemiluminescence detection. Analyzers: cobas e series. Sample matrices: serum, potassium EDTA, lithium heparin, sodium heparin, sodium citrate. Automated signal processing.

Indications for Use

Indicated for adult and pediatric (2-21 years) patients with signs/symptoms of hepatitis or at risk for HAV infection to aid in diagnosis of acute/recent HAV infection.

Regulatory Classification

Identification

HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors.

Special Controls

*Classification.* Class II (special controls). The special control is “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.” See § 866.1(e) for the availability of this guidance document.

Predicate Devices

• Access anti-HAV IgM (K251995)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K260048

B Applicant

Roche Diagnostics

C Proprietary and Established Names

Elecsys Anti-HAV IgM

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| SEI | Class II | 21 CFR 866.3310
Hepatitis A virus (HAV)
serology assay | MI - Microbiology |

## II Submission/Device Overview:

A Purpose for Submission:

Addition of pediatric patients (2 through 21 years of age) to the intended use population.

B Measurand:

IgM antibodies to hepatitis A virus

C Type of Test:

Qualitative electrochemiluminescence immunoassay (ECLIA)

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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III Intended Use/Indications for Use:

A Intended Use(s):
Immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) from adult and pediatric (2 to 21 years of age) patients with signs and symptoms of hepatitis or persons who may be at risk for hepatitis A infection. The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus (HAV) infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HAV.

The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

B Indication(s) for Use:
See Intended Use

C Special Conditions for Use Statement(s):
Rx – For Prescription Use Only

D Special Instrument Requirements:
For use with e cobas immunoassay analyzers.

IV Device/System Characteristics:

A Device Description:
The Elecsys Anti-HAV IgM immunoassay utilizes a μ-capture test concept based on a monoclonal h-IgM directed biotinylated antibody, cell culture derived Hepatitis A Virus and a ruthenylated monoclonal antibody directed to HAV. Capture of formed immune complexes from the reaction mixture is based on biotin binding to streptavidin-coated magnetic microparticles which are collected on a measuring cell electrode. Signal generation is triggered by the application of a voltage to the electrode (electrochemiluminescence technology). Results are determined automatically by comparing the signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration. The Elecsys Anti-HAV IgM test kit includes 2 Anti-HAV IgM calibrators, one consisting of human serum negative for anti-HAV IgM and one positive calibrator consisting of Anti-HAV IgM in human serum. PreciControl Anti-HAV IgM is also available and is packaged and sold separately. The Elecsys PreciControl Anti-HAV IgM contains control serum based on human serum in the negative and positive concentration ranges. The controls are used for monitoring the accuracy of Elecsys Anti-HAV IgM immunoassays.

B Principle of Operation:
The Elecsys Anti-HAV IgM immunoassay employs electrochemiluminescence technology and is a qualitative serological, μ-capture assay. Total duration of the assay is 18 minutes.

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1st incubation: Pretreatment of $10~\mathrm{uL}$ of the automatically 1:400 diluted sample (using Diluent Universal) with anti-Fdy reagent to block specific IgG in the presence of monoclonal anti-HAV antibodies labeled with ruthenium complex. $^{a)}$

2nd incubation: After addition of biotinylated monoclonal h-IgM-specific antibodies, HAV antigen, and streptavidin-coated microparticles, the anti-HAV IgM antibodies present in the sample form a sandwich complex with the HAV antigen and the ruthenium-labeled anti-HAV antibody 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/ProCell 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

The cutoff for the Elecsys Anti-HAV IgM assay was initially established by measuring a total of 1004 samples including 575 negative from post acute, dialysis, hospitalized, routine samples with request for anti-HAV IgM testing, samples from blood donors and 429 positive samples from seroconverters $< 90$ days (commercial sources), HAV follow-ups after infection $< 90$ days and samples suspected for HAV obtained from several European sites. The distribution of positive, equivocal and negative results was compared with the AxSym HAVAB-M 2.0 assay and the cutoffs were set as noted below. The result of a sample is given in the form of a cutoff index (signal sample/cutoff).

Results obtained with the Elecsys Anti-HAV IgM assay can be interpreted as follows:

| Non-reactive | < 0.90 COI |
| --- | --- |
| Border | 0.90 ≤ COI < 1.10 |
| Reactive | COI ≥ 1.10 |

Samples with a $\mathrm{COI} &lt; 0.90$ are considered non-reactive in the Elecsys Anti-HAV IgM assay and no further testing is necessary. Samples with a $\mathrm{COI} \geq 1.10$ are considered reactive in the Elecsys Anti-HAV IgM assay. Samples with a COI between 0.90 and $&lt; 1.10$ are considered border (borderline). The sample should be retested in duplicate.

- If 2 of the 3 results have a $\mathrm{COI} &lt; 0.90$ , the result is interpreted as non-reactive, and no further testing is necessary.
- If 2 of the 3 results have a COI between 0.90 and $&lt; 1.10$ , the result is interpreted as borderline. It is recommended that a specimen be drawn in 2 weeks and retested.
- If 2 of the 3 results have a $\mathrm{COI} \geq 1.10$ , the result is interpreted as reactive.

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V Substantial Equivalence Information:

A Predicate Device Name(s):
Access anti-HAV IgM

B Predicate 510(k) Number(s):
K251995

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K260048 | K251995 |
| --- | --- | --- |
| Device Trade Name | Elecsys Anti-HAV IgM | Access anti-HAV IgM |
| General Device Characteristic Similarities | | |
| Regulation Number | 21 CFR 866.3310 | Same |
| Regulation Name | Hepatitis A virus (HAV) serological assays | Same |
| Regulatory Class | II | Same |
| Product Code | LOL | Same |
| Intended Use | Immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) from adult and pediatric (2 to 21 years of age) patients with signs and symptoms of hepatitis or persons who may be at risk for hepatitis A infection. The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus (HAV) infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive | The Access anti-HAV IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human pediatric (2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, and tripotassium (K3) EDTA] using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HAV IgM assay results may be used as an aid in the laboratory diagnosis of acute or recent hepatitis A virus (HAV) infection in individuals with signs and symptoms of hepatitis A |

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| | evidence of infection with HAV.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. | virus, when used in conjunction with other serological and clinical information.
This assay is not intended for use for screening donors of blood or blood products or human cells, tissues, or cellular or tissue-based products (HCT/Ps). |
| --- | --- | --- |
| Test principle | μ Capture test principle | Two-step sandwich immunoassay |
| Analyte measured | Anti-HAV IgM | Same |
| General Device Characteristic Differences | | |
| Sample type/matrix | Human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) | Serum and Plasma [Lithium Heparin, Lithium Heparin separator tube, dipotassium (K2) EDTA, and tripotassium (K3) EDTA] |
| Instrument platform | cobas e immunoassay analyzers | DxI 9000 Access Immunoassay Analyzer |
| Calibrator | AHAVIGM Cal1
AHAVIGM Cal2 | Access anti-HAV IgM Calibrator |
| Controls | PreciControl Anti-HAV IgM | Access anti-HAV IgM |

VI Standards/Guidance Documents Referenced:

Hepatitis A Virus Serological Assays - Class II Special Controls Guidance for Industry and FDA Staff

EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility: See K093955
2. Linearity:

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Not applicable.

3. Analytical Specificity/Interference: See K093955
4. Detection Limit and Assay Reportable Range: Not applicable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): See K093955
6. Assay Cut-Off: See K093955

## B Comparison Studies:

1. Method Comparison with Predicate Device:

### Clinical performance in pediatric subjects

The performance of the Elecsys Anti-HAV IgM assay on the cobas e 801 immunoassay analyzer and an FDA-approved Anti-HAV IgM reference assay was performed on 123 pediatric subjects for hepatitis from US subjects.

| | Reference Anti-HAV IgM assay final interpretation | | |
| --- | --- | --- | --- |
| Anti-HAV IgM | Reactive | Grayzone | Non-reactive |
| Reactive | 0 | 0 | 0 |
| Borderline | 0 | 0 | 0 |
| Non-reactive | 0 | 0 | 123 |
| Total | 0 | 0 | 123 |
| Percent agreement in pediatric subject population | |
| --- | --- |
| Positive percent agreement | NA (0/0) |
| 95 % confidence interval | NA |
| Negative percent agreement | 100 (123/123) |
| 95 % confidence interval | 97.0 to 100 |

Due to the low prevalence of HAV in the pediatric population, a comparative study comparing 30 spiked pediatric samples against one adult sample pool was performed with Elecsys Anti-HAV IgM. 30 pediatric samples that were anti-HAV IgM antibody negative and one adult anti-HAV IgM-negative sample pool were spiked with analyte from a high positive sample to the level of 2-4 times the cutoff to assess performance.

The percent difference between all 30 pediatric samples the adult samples met the acceptance criteria which was ≤ 20% supporting that the assay is suitable for the pediatric population.

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2. Matrix Comparison: See K093955

## C Clinical Studies:

1. Clinical Sensitivity: Not Applicable.
2. Clinical Specificity: Not Applicable.
3. Clinical Cut-Off: Not Applicable.
4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): See K093955 and below

## D Expected Values/Reference Range: See K093955

## 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.

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