Access anti-HBc Total

K253687 · Beckman Coulter, Inc. · SEI · Feb 19, 2026 · Microbiology

Device Facts

• Record ID: K253687
• Device Name: Access anti-HBc Total
• Applicant: Beckman Coulter, Inc.
• Product Code: SEI · Microbiology
• Decision Date: Feb 19, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3173
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Access anti-HBc Total assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of total antibodies to hepatitis B virus core antigen (anti-HBc) 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, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD) and citrate phosphate dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HBc Total assay may be used as an aid in the laboratory diagnosis of acute, chronic or resolved hepatitis B virus (HBV) infection of individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, including pregnant women, when used in conjunction with other laboratory results and clinical information. The Access anti-HBc Total assay is for use on the DxI 9000 Access Immunoassay Analyzer only. This assay is not intended for the screening of blood, plasma, and cell or tissue donors.

Device Story

The Access anti-HBc Total assay is a two-step competitive chemiluminescent immunoassay (CLIA) performed on the DxI 9000 Access Immunoassay Analyzer. Patient serum or plasma is incubated with paramagnetic particles coated with HBc antigen; patient anti-HBc antibodies bind to the solid phase. Alkaline phosphatase-conjugated HBc monoclonal antibodies are added, competing with patient antibodies for binding sites. After washing, a chemiluminescent substrate is added; light output is measured by a luminometer. The system software automatically compares light production to a stored calibration curve to determine a Signal/Cutoff (S/CO) ratio. Results are reported as reactive (< 1.00 S/CO) or nonreactive (≥ 1.00 S/CO). The device is used in clinical laboratory settings by trained personnel to aid in the diagnosis of HBV infection. The output provides clinicians with qualitative serological status, which, when combined with other laboratory markers and clinical information, informs the diagnosis and management of HBV infection.

Clinical Evidence

Clinical performance was evaluated in a multi-center study of 2,391 prospectively collected specimens (adults, pediatric, pregnant). The study compared the Access anti-HBc Total assay to an FDA-approved reference assay. Overall PPA was 98.4% (95% CI: 96.67-99.21%) and NPA was 98.9% (95% CI: 98.37-99.30%). Subgroup analysis confirmed performance across HBV classifications (acute, chronic, recovery, immune). Analytical sensitivity was 0.69 IU/mL. No cross-reactivity was observed with various viral antibodies or autoimmune conditions. Interference testing showed no impact from common endogenous/exogenous substances.

Technological Characteristics

Two-step competitive chemiluminescent immunoassay (CLIA) using paramagnetic particles. Instrumentation: DxI 9000 Access Immunoassay Analyzer. Sample types: serum, SST, plasma (Li-Heparin, EDTA, Citrate, ACD, CPD). Detection: luminometer-based light measurement. Software: automated result interpretation based on stored calibration. Sterilization: N/A (reagents). Connectivity: integrated with DxI 9000 analyzer, compatible with DxA 5000 automation line.

Indications for Use

Indicated for the qualitative detection of total (IgG and IgM) antibodies to hepatitis B virus core antigen (anti-HBc) in human pediatric (2-21 years) and adult serum and plasma. Used as an aid in the diagnosis of acute, chronic, or resolved HBV infection in individuals with signs/symptoms of hepatitis or at risk for HBV infection, including pregnant women. Not for blood, plasma, or tissue donor screening.

Regulatory Classification

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

• Architect CORE (P080023)

Submission Summary (Full Text)

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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number

K253687

B Applicant

Beckman Coulter Inc.

C Proprietary and Established Names

Access Anti-HBc Total

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| SEI, QCH | Class II | 21 CFR 866.3173 – Hepatitis B Virus (HBV) Antibody Assay | MI - Microbiology |

## II Submission/Device Overview:

A Purpose for Submission:

To obtain clearance for marketing the Access anti-Hepatitis B core (anti-HBc) Total Assay, Access Anti-HBc Total Calibrator, and Access Anti-HBc Total Quality Control (QC).

B Measurand:

Total (IgG and IgM) antibodies to Hepatitis B core.

C Type of Test:

Chemiluminescent immunoassay (CLIA).

## III Intended Use/Indications for Use:

A Intended Use(s):

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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See Indications for Use below.

## B Indication(s) for Use:

**Access anti-HBc Total assay.**

The Access anti-HBc Total assay is a paramagnetic particle, chemiluminescent immunoassay for the *in vitro* qualitative detection of total antibodies to hepatitis B virus core antigen (anti-HBc) 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, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD) and citrate phosphate dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer.

The Access anti-HBc Total assay may be used as an aid in the laboratory diagnosis of acute, chronic or resolved hepatitis B virus (HBV) infection of individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, including pregnant women, when used in conjunction with other laboratory results and clinical information.

The Access anti-HBc Total assay is for use on the DxI 9000 Access Immunoassay Analyzer only.

This assay is not intended for the screening of blood, plasma, and cell or tissue donors.

**Access anti-HBc Total Calibrator.**

The Access anti-HBc Total Calibrator is intended to calibrate the Access anti-HBc Total assay for the *in vitro* qualitative detection of hepatitis B virus core total antibodies (anti-HBc) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer.

**Access anti-HBc Total QC.**

The Access anti-HBc Total QC is intended for monitoring system performance of the Access anti-HBc Total assay. The Access anti-HBc Total QC is for use on the DxI 9000 Access Immunoassay Analyzer.

## C Special Conditions for Use Statement(s):

Rx – For Prescription Use Only

## D Special Instrument Requirements:

For Use with the DxI 9000 Analyzer from Beckman Coulter, Inc.

## IV Device/System Characteristics:

### A Device Description:

The Access anti-HBc Total assay is a two-step competitive immunoassay for the qualitative detection of total antibodies (anti-HBc IgG and IgM) to hepatitis B core antigen of hepatitis B virus (HBV) using the DxI 9000 Analyzer. The Access anti-HBc Total assay requires Access anti-HBc Total (reagent packs), Access anti-HBc Total Calibrator (C1), and Access anti-HBc Total QC (QC1-QC2).

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# B Principle of Operation:

Paramagnetic particles coated with HBc antigen and sample are added to a reaction vessel. Anti-HBc antibodies present in the patient sample bind to the antigen-coated particles during the incubation, after which the material bound to the solid phase are held in a magnetic field while unbound materials are washed away. Alkaline phosphatase coupled to HBc monoclonal antibodies is added and this conjugate competes with the patient antibodies bound to the HBc antigens coated on the particles.

After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. A chemiluminescent substrate is then added to the vessel and light generated by the reaction is measured with a luminometer. The light production is compared to the cutoff value defined during calibration of the instrument. The qualitative assessment is automatically determined from a stored calibration.

# Results interpretation:

Test results are determined automatically by the system software. Results (Signal/Cutoff (S/CO)) are reported as reactive or nonreactive as follows:

| Result (S/CO) | Interpretation | Reporting Instructions |
| --- | --- | --- |
| < 1.00 | Reactive | Report result as reactive for anti-HBc Total antibodies |
| ≥ 1.00 | Nonreactive | Report result as nonreactive for anti-HBc Total antibodies |

# C Instrument Description Information:

1. Instrument Name:
DxI 9000 Immunoassay Analyzer

2. Specimen Identification:
Total (IgG and IgM) antibodies to Hepatitis B core antigen in human serum and plasma

3. Specimen Sampling and Handling:
Collection tubes include serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K₂) EDTA, tripotassium (K₃) EDTA, sodium citrate, acid-citrate-dextrose (ACD), and citrate phosphate-dextrose (CPD)].

4. Calibration:
Access anti-HBc Total Calibrator consists of 1 level (positive) (C1) provided as liquid ready-to-use.

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5. Quality Control:

Access anti-HBc Total QC consist of a negative (QC1) and a positive (QC2) control provided as liquid ready-to-use.

V Substantial Equivalence Information:

A Predicate Device Name(s):

Architect CORE

B Predicate 510(k) Number(s):

P080023

C Comparison with Predicate(s):

| Device & Predicate Device(s): | P080023
Predicate | K253687
Candidate |
| --- | --- | --- |
| Device Trade Name | ARCHITECT CORE | ACCESS Anti-HBc Total |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The ARCHITECT CORE assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG and IgM antibodies to hepatitis B core antigen (anti-HBc) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, sodium heparin) and neonatal serum. It is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information. | The Access anti-HBc Total assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of total antibodies to hepatitis B virus core antigen (anti-HBc) 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, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD) and citrate phosphate dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HBc Total assay may be used as an aid in the laboratory diagnosis of acute, chronic or resolved hepatitis B virus (HBV) infection of individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, including pregnant women, when used in conjunction with |

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| | Calibrator: The ARCHITECT CORE Calibrator is used for the calibration of the ARCHITECT i System when the system is used for the qualitative detection of IgG and IgM antibodies to hepatitis B core antigen (anti-HBc) with the ARCHITECT CORE Reagent Kit. The performance of the ARCHITECT CORE Calibrator has not been established with any other anti-HBc assays.

QC: The ARCHITECT CORE Controls are used for monitoring the performance of the ARCHITECT i System when used for the qualitative detection of IgG and IgM antibodies to hepatitis B core antigen (anti-HBc) with the ARCHITECT CORE Reagent Kit. The performance of the ARCHITECT CORE Controls has not been established with any other anti-HBc assays. | other laboratory results and clinical information.
The Access anti-HBc Total assay is for use on the DxI 9000 Access Immunoassay Analyzer only.
This assay is not intended for the screening of blood, plasma, and cell or tissue donors.

Calibrator: The Access anti-HBc Total Calibrator is intended to calibrate the Access anti-HBc Total assay for the in vitro qualitative detection of hepatitis B virus core total antibodies (anti-HBc) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer.

QC: The Access anti-HBc Total QC is intended for monitoring system performance of the Access anti-HBc Total assay. The Access anti-HBc Total QC is for use on the DxI 9000 Access Immunoassay Analyzer. |
| --- | --- | --- |
| Analyte Measured | Anti-HBc IgG and IgM | same |
| Assay Type | Qualitative | same |
| Detection Method | Automated, chemiluminescent Microparticle Immunoassay (CMIA) | similar: automated, chemiluminescent |
| Reagent, Calibrator, and QC Format | Liquid, ready to use | same |
| Control(s) | 2-levels, 1 Neg. Control, 1 Pos. Control | same |
| Sample Type | Serum and Plasma | same |
| Compatible Anticoagulants | Human serum, plasma (dipotassium EDTA, Lithium Heparin, Sodium Heparin) | Human serum, Serum separator tube, Plasma [Lithium Heparin, Lithium Heparin separator tube, Dipotassium EDTA, Tripotassium EDTA, Sodium Citrate, Acid Citrate Dextrose (ACD) Citrate Phosphate Dextrose (CPD)] |
| General Device Characteristic Differences | | |

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| Assay Type | noncompetitive | competitive |
| --- | --- | --- |
| Sample Volume | 75 μL | 105 μL |
| Calibrator(s) | 2-level Calibrator 1 (positive) | 1-level Calibrator 1 (positive) |
| Instrumentation | ARCHITECT i Systems | DxI 9000 Access Immunoassay Analyzer |
| Target population | Adult and pediatrics | Adult, pediatrics, pregnant women |
| | As aid in the diagnosis of acute, chronic, or resolved hepatitis B virus (HBV) infection | As aid in the laboratory diagnosis of acute, chronic or resolved hepatitis B virus (HBV) infection of individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection |

VI Standards/Guidance Documents Referenced:

1. CLSI EP05-A3 (R2019): Evaluation of Precision of Quantitative Measurement Procedures; 2019.
2. CLSI EP07-A3: Interference Testing in Clinical Chemistry; 2018.
3. CLSI EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples, Third Edition; 2018.
4. CLSI EP24-A2: Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline – Second Edition; 2011.
5. CLSI EP25-A: Evaluation of Stability of In Vitro Medical Laboratory Reagents – Second Edition; 2023.
6. CLSI EP37: Supplemental Tables for Interference Testing in Clinical Chemistry – First Edition; 2018.
7. GP44-A4 (Formerly H18-A4): Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition; 2014.
8. ISO 14971: Medical devices – Application of risk management of medical devices – Third Edition; 2019.
9. ISO 15223-1: Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements – Fourth Edition; 2021.
10. ISO 17511: In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators trueness control materials and human samples – second edition; 2020.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

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# A. Precision.

Within-laboratory precision of the Access anti-HBc Total assay was evaluated at one internal site on three Dxl 9000 Analyzers. Four serum and four plasma specimens (2 reactive and 2 non-reactive for each matrix) were tested in 3 replicates per run, 2 runs per day, for 20 days, using 3 lots of Access anti-HBc Total reagent kit and 2 Access anti-HBc Total Calibrator lots. The precision study results are summarized in Table 1.

Table 1. Access Anti-HBc Total within-laboratory precision study results

| Sample | N | Mean (S/CO) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Between- Reagent Lot | | Between- Instrument | | Within Laboratory | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD (S/CO) | %CV | SD (S/CO) | %CV | SD (S/CO) | %CV | SD (S/CO) | %CV | SD (S/CO) | %CV | SD (S/CO) | %CV |
| QC1 | 2,160 | 6.24 | 0.170 | 2.7 | 0.225 | 3.6 | 0.099 | 1.6 | 0.156 | 2.5 | 0.093 | 1.5 | 0.350 | 5.6 |
| QC2 | 2,160 | 0.31 | 0.015 | N/A | 0.018 | N/A | 0.000 | N/A | 0.009 | N/A | 0.010 | N/A | 0.027 | N/A |
| S1 | 2,160 | 5.14 | 0.146 | 2.8 | 0.209 | 4.1 | 0.048 | 0.9 | 0.138 | 2.7 | 0.122 | 2.4 | 0.318 | 6.2 |
| S2 | 2,160 | 1.20 | 0.046 | 3.9 | 0.060 | 5.0 | 0.020 | 1.7 | 0.032 | 2.7 | 0.016 | 1.4 | 0.087 | 7.2 |
| S3 | 2,160 | 0.85 | 0.031 | 3.7 | 0.044 | 5.2 | 0.018 | 2.2 | 0.021 | 2.4 | 0.011 | 1.3 | 0.061 | 7.2 |
| S4 | 2,160 | 0.10 | 0.005 | N/A | 0.004 | N/A | 0.003 | N/A | 0.003 | N/A | 0.002 | N/A | 0.008 | N/A |
| P1 | 2,160 | 5.21 | 0.135 | 2.6 | 0.158 | 3.0 | 0.138 | 2.6 | 0.141 | 2.7 | 0.107 | 2.1 | 0.306 | 5.9 |
| P2 | 2,160 | 1.16 | 0.051 | 4.4 | 0.050 | 4.3 | 0.049 | 4.2 | 0.033 | 2.8 | 0.015 | 1.3 | 0.094 | 8.1 |
| P3 | 2,160 | 0.82 | 0.035 | 4.3 | 0.029 | 3.5 | 0.040 | 4.8 | 0.022 | 2.7 | 0.010 | 1.2 | 0.065 | 7.9 |
| P4 | 2,160 | 0.09 | 0.005 | N/A | 0.003 | N/A | 0.004 | N/A | 0.003 | N/A | 0.002 | N/A | 0.008 | N/A |

Note: %CV are not meaningful when S/CO approaches zero. Results are noted as N/A.

Within-laboratory precision of the Access anti-HBc Total assay on the Automation Line DxA 5000 total laboratory automation system coupled to the DxI 9000 Access Immunoassay Analyzer was evaluated at one internal site on one DxI 9000 Analyzer. The same panel samples used for the within-laboratory precision study were tested in 3 replicates per run, 2 runs per day, for 20 days, using 1 reagent pack lot and 1 calibrator lot. The precision study results are summarized in Table 2.

Table 2. Access Anti-HBc Total within-laboratory precision study results on the Automation Line DxA 5000 total laboratory automation system

| Sample | Mean (S/CO) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within Laboratory | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | SD (S/CO) | %CV | SD (S/CO) | %CV | SD (S/CO) | %CV | SD (S/CO) | %CV |
| QC1 | 6.71 | 0.217 | 3.2 | 0.168 | 2.5 | 0.108 | 1.6 | 0.295 | 4.4 |
| QC2 | 0.32 | 0.015 | 4.5 | 0.016 | 4.9 | 0.000 | 0.0 | 0.022 | N/A |
| S1 | 5.17 | 0.201 | 3.9 | 0.180 | 3.5 | 0.038 | 0.7 | 0.272 | 5.3 |
| S2 | 1.18 | 0.048 | 4.1 | 0.051 | 4.3 | 0.029 | 2.4 | 0.076 | 6.4 |
| S3 | 0.83 | 0.033 | 4.0 | 0.044 | 5.3 | 0.022 | 2.6 | 0.059 | 7.2 |
| S4 | 0.10 | 0.006 | 6.3 | 0.005 | 5.6 | 0.002 | 2.0 | 0.008 | N/A |
| P1 | 5.33 | 0.146 | 2.7 | 0.210 | 3.9 | 0.072 | 1.3 | 0.266 | 5.0 |
| P2 | 1.15 | 0.050 | 4.4 | 0.057 | 4.9 | 0.016 | 1.4 | 0.077 | 6.7 |
| P3 | 0.82 | 0.042 | 5.1 | 0.049 | 5.9 | 0.000 | 0.0 | 0.064 | 7.8 |
| P4 | 0.09 | 0.006 | 6.8 | 0.005 | 5.4 | 0.000 | 0.0 | 0.008 | N/A |

# B. Reproducibility

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A 5-day reproducibility study was performed at 3 testing sites (1 instrument per site). Four serum and four plasma specimens (2 reactive and 2 non-reactive for each matrix) were tested using one lot of Access anti-HBc Total reagent kit, Access anti-HBc Total Calibrator, and Access anti-HBc Total QC. Samples were tested in 3 replicates per run, 2 runs per day, for 5 days. The reproducibility study results are summarized in Table 3.

Table 3. Access Anti-HBc Total reproducibility study results

| Sample | N | Mean (S/CO) | Repeatability (Within Run) | | Between-Run | | Between-Day | | Between-Site | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD (S/CO) | %CV | SD (S/CO) | %CV | SD (S/CO) | %CV | SD (S/CO) | %CV | SD (S/CO) | %CV |
| S1 | 90 | 5.02 | 0.204 | 4.1% | 0.041 | 0.8% | 0.056 | 1.1% | 0.076 | 1.5% | 0.228 | 4.5% |
| S2 | 90 | 1.20 | 0.059 | 4.9% | 0.005 | 0.4% | 0.030 | 2.5% | 0.043 | 3.6% | 0.079 | 6.6% |
| S3 | 90 | 0.85 | 0.051 | 5.9% | 0.000 | 0.0% | 0.008 | 0.9% | 0.027 | 3.1% | 0.058 | 6.8% |
| S4 | 90 | 0.10 | 0.007 | N/A | 0.001 | N/A | 0.001 | N/A | 0.006 | N/A | 0.010 | N/A |
| P1 | 90 | 5.21 | 0.172 | 3.3% | 0.109 | 2.1% | 0.031 | 0.6% | 0.148 | 2.8% | 0.254 | 4.9% |
| P2 | 90 | 1.15 | 0.065 | 5.6% | 0.056 | 4.9% | 0.000 | 0.0% | 0.062 | 5.4% | 0.105 | 9.2% |
| P3 | 90 | 0.81 | 0.037 | 4.5% | 0.028 | 3.5% | 0.022 | 2.7% | 0.038 | 4.6% | 0.064 | 7.8% |
| P4 | 90 | 0.09 | 0.007 | N/A | 0.003 | N/A | 0.001 | N/A | 0.005 | N/A | 0.009 | N/A |

Note: %CV are not meaningful when S/CO approaches zero. Results are noted as N/A.

# 2. Linearity:

N/A

# 3. Analytical Specificity/Interference:

# A. Cross-reactivity

Potential cross-reactivity in the Access anti-HBc Total assay was evaluated using specimens with viral antibodies and from patients with related conditions. The anti-HBc total status of each specimen was verified using a commercially available comparator anti-HBc total assay. No cross-reactivity was observed. The cross-reactants, numbers of samples, and study results are summarized in Table 4.

Table 4. Cross-reactivity of Access anti-HBc Total assay

| Category | Number of Samples Tested | Number of Reactive Samples by Access anti-HBc Total | Number of Nonreactive Samples by Access anti-HBc Total |
| --- | --- | --- | --- |
| Epstein-Barr virus (EBNA IgG or VCA IgG) | 10 | 0 | 10 |
| Cytomegalovirus (CMV) | 10 | 0 | 10 |
| Herpes simplex virus (HSV 1/2) | 10 | 0 | 10 |
| Human immunodeficiency virus (HIV) | 10 | 0 | 10 |
| Hepatitis A virus (HAV) | 10 | 0 | 10 |
| Hepatitis C virus (HCV) | 10 | 0 | 10 |
| Hepatitis E virus (HEV) | 10 | 0 | 10 |

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| Category | Number of Samples Tested | Number of Reactive Samples by Access anti-HBc Total | Number of Nonreactive Samples by Access anti-HBc Total |
| --- | --- | --- | --- |
| Alcoholic liver disease | 10 | 0 | 10 |
| Primary biliary cirrhosis | 10 | 0 | 10 |
| Flavivirus (Zika) | 10 | 0 | 10 |
| Flavivirus (Dengue) | 10 | 0 | 10 |
| Flavivirus (West Nile) | 10 | 0 | 10 |
| Influenza post-vaccination | 10 | 0 | 10 |
| HAMA | 10 | 1 | 9 |
| Anti-nuclear antibody (ANA) | 10 | 0 | 10 |
| Rheumatoid Factor | 10 | 0 | 10 |
| Systemic lupus erythematosus (SLE) | 10 | 0 | 10 |
| Multiple Myeloma | 10 | 0 | 10 |
| Pregnancy multipara | 10 | 0 | 10 |
| Pregnancy first trimester | 10 | 0 | 10 |
| Pregnancy second trimester | 10 | 0 | 10 |
| Pregnancy third trimester | 10 | 0 | 10 |
| Syphilis | 10 | 0 | 10 |
| Toxoplasmosis | 10 | 0 | 10 |
| Transplant recipient | 10 | 0 | 10 |
| Dialysis patients | 10 | 0 | 10 |
| Hemophiliac / Clotting factor | 10 | 0 | 10 |
| anti-E.coli | 10 | 0 | 10 |
| Rubella | 10 | 0 | 10 |
| Varicella Zoster Virus (VZV) | 10 | 0 | 10 |
| Measles | 10 | 0 | 10 |
| Mumps | 10 | 0 | 10 |

# B. Interference

Potential interference of endogenous and exogenous substances was evaluated using three plasma samples: negative for anti-HBc $(\geq 1.30~\mathrm{S / CO})$ , high negative $(\sim 1.1 - 1.3~\mathrm{S / CO})$ and low positive $(\sim 0.7 - 0.9~\mathrm{S / CO})$ . Each sample was spiked with each of the potential interfering substances, tested in 5 replicates, and compared to controls (sample without interferents). Of the compounds tested, none were found to cause interference using the highest test concentrations indicated in Table 5.

Table 5. Interfering Substances

| Potential Interferent | Concentration Tested |
| --- | --- |
| Hemoglobin | 500 mg/dL |
| Total Protein | 15 g/dL |
| Bilirubin conjugated | 40 mg/dL |
| Bilirubin unconjugated | 40 mg/dL |
| Triglycerides (Intralipid) | 19.20 mmol/L (2.000 mg/dL) |
| Aspirin (acetylsalicylic acid) | 167 μmol/L |
| Salicylic acid | 207 μmol/L |

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| Potential Interferent | Concentration Tested |
| --- | --- |
| Acetaminophen (paracetamol) | 1,030 μmol/L |
| Ibuprofen | 1,060 μmol/L |
| Atorvastatin | 1.34 μmol/L |
| Lisinopril | 0.607 μmol/L |
| Levothyroxine | 0.552 μmol/L |
| Metformin | 92.9 μmol/L |
| Amlodipine | 0.183 μmol/L |
| Omeprazole | 24.3 μmol/L |
| Sertraline | 3.03 μmol/L |
| Cholesterol | 400 mg/dL |

## C. Hook effect.

N/A

4. Assay Reportable Range:

N/A

5. Stability (Controls, Calibrators, or Methods):

### Reagent Stability

Reagent real time stability, in-use stability, and stored curve stability studies supported the following stability claims:

| Stability Study | Reagent | Storage temperature | Supported claim |
| --- | --- | --- | --- |
| Shelf-life | Access anti-HBc Total | 2-10°C | 365 days |
| | Access anti-HBc Total Calibrator | 2-10°C | 365 days |
| | Access anti-HBc Total QC | 2-10°C | 296 days |
| Open vial | Access anti-HBc Total | 2-10°C | 45 days |
| | Access anti-HBc Total Calibrator | 2-10°C | 180 days |
| | Access anti-HBc Total QC | 2-10°C | 62 days |
| Stored curve | Access anti-HBc Total | N/A* | 56 days |

*Stored curve stability study was executed with the calibration curve stored on the DxI 9000 Access Immunoassay Analyzer.

### Sample Stability

A study was conducted to evaluate the effect of sample handling and storage conditions at room temperature (20 – 25°C), refrigerated (2 - 8°C), and frozen (≤ -18°C). It also evaluated sample stability after multiple freeze/thaw cycles. Sample stability studies support the following stability claims:

| Storage Condition | Claimed Stability |
| --- | --- |

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| Room Temp Storage (20-25° C) | Up to 3 Days |
| --- | --- |
| Refrigerated Storage (2-8° C) | Up to 7 Days |
| Frozen Storage (≤-20° C) | Up to 30 Days |
| Freeze/Thaw Cycles | No more than 4 cycles |

## 6. Analytical Sensitivity:

### A. Analytical sensitivity at cut-off

The Access anti-HBc Total assay was designed to have an analytical sensitivity of less than 1.40 IU/mL using the 1st International Standard (IS) material for Anti-HBc, NIBSC code: 95/522.

A series of dilutions were prepared using the 1st IS for Anti-HBc with target concentrations in the range of 0.1-1.0 IU/mL, using three reagent and three calibrator lots on two DxI 9000 Access Immunoassay Analyzers. The analytical sensitivity for each reagent/calibrator lot combination was determined using a quadratic model (2nd order polynomial) of log-transformed S/CO measurements versus the IS anti-HBc concentrations (IU/mL). The point estimate of the IS concentration corresponding to 1.00 S/CO was used in the analytical sensitivity estimation. The maximum overall analytical sensitivity results determined in this study are summarized below.

| Standard | Analytical Sensitivity |
| --- | --- |
| 1st International Standard NIBSC code: 95/522 | 0.69 IU/mL (95% CI: 0.69 - 0.69 IU/mL) |

### B. Seroconversion

Commercially available patient seroconversion panels were tested using the Access anti-HBc Total assay and a reference assay to determine the seroconversion sensitivity of the assay. Equivalent detection with no difference in bleed number was observed in 4 of the 7 panels and earlier detection by the Access anti-HBc Total assay was observed in 3 panels. The results are summarized in Table 6.

Table 6. Seroconversion Sensitivity Results

| Panel ID | First anti-HBc Total positive result from initial draw date | | Access anti-HBc Total vs reference assay |
| --- | --- | --- | --- |
| | Access anti-HBc Total assay (days) | Reference assay (days) | Difference in bleed number for the first reactive bleed* |
| HBV-6281 | 41 | 41 | 0 |
| HBV-9092 | 85 | 85 | 0 |
| HBV-9093 | 49 | 49 | 0 |
| HBV-9072 | 159 | >159** | ≤-1** |
| HBV-001 | 29 | 29 | 0 |
| HBV-002 | 56 | 59 | -1 |
| HBV-004 | 65 | 71 | -1 |

* The difference in bleed number is compared to the reference assay. For example, -1 indicates that the reference assay required 1 additional bleed before reactivity was determined compared to the Access anti-HBc Total assay.
**The panel never seroconverted from a nonreactive status to a reactive status with the reference anti-HBc Total assay.

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# B Comparison Studies:

# 1. Method Comparison with Predicate Device:

A multi-center study was conducted using the DxI 9000 Access Immunoassay Analyzer to evaluate the ability of the Access anti-HBc Total assay to detect anti-HBc Total in serum specimens from the intended use population. The study consists of a qualitative method comparison agreement with a reference assay (FDA-approved Anti-HBc Total assay). A total of 2,391 prospectively collected specimens from individuals at increased risk for hepatitis B or with signs and symptoms of hepatitis were tested and included:

2,065 adult samples (non-pregnant)
155 pediatric samples (2-21 years)
171 pregnant women samples.

The HBV classification was determined for each specimen based on the reactivity patterns of 6 HBV serological marker results (HBsAg, HBeAg, anti-HBc IgM, total anti-HBc, anti-HBe, and anti-HBs).

The negative percent agreement (NPA) and positive percent agreement (PPA) results for the prospectively collected non-pregnant adults, pediatric non-pregnant, pregnant, and combined for all cohorts are presented in Tables 7-12.

Table 7. Percent Agreement between Access Anti-HBc Total and Comparator Anti-HBc Total Final Interpretation by HBV Disease Classification: Non-Pregnant Adult at Increased Risk and/or Signs and Symptoms Cohort (n=2,065)

| HBV Classification | PPA | | NPA | |
| --- | --- | --- | --- | --- |
| | % (n/N) | 95% CI | % (n/N) | 95% CI |
| Acute | 100.0% (1/1) | (20.7-100.0%) | 100.0 (2/2) | (34.2-100.0%) |
| Recovery | 99.5% (196/197) | (97.2-99.9%) | 25.0 (1/4) | (4.6-69.9%) |
| Chronic | 96.8% (92/95) | (91.1-98.9%) | 0 (0/0) | N/A |
| Immune due to natural infection | 97.5% (119/122) | (93.0-99.2%) | 0 (0/0) | N/A |
| Immune due to HBV Vaccination | 0 (0/0) | N/A | 98.4% (692/703) | (97.2-99.1%) |
| Not previously infected | 0 (0/0) | N/A | 99.2 (922/929) | (98.5-99.6%) |
| Not interpretable/Unknown profilea | 100.0 (7/7) | (64.6-100.0%) | 100.0 (3/3) | (43.9-100.0%) |
| Missing test datab | 100.0 (1/1) | (20.7-100.0%) | 100.0 (1/1) | (20.7-100.0%) |
| Total | 98.3% (416/423) | 96.6-99.2% | 98.7% (1,621/1,642) | 98.1-99.2% |

a Samples were classified as "Not Interpretable" if their HBV seroprofile was predefined in the study protocol, and "Unknown" if not predefined. For data presentation, these are grouped as "Not Interpretable/Unknown", due to both groups having atypical seropatterns not aligning with HBV classification criteria.

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b Samples were classified as "Missing Test Data" if insufficient volume was available to determine the HBV classification.

Table 8. Percent Agreement between Access Anti-HBc Total and Comparator Anti-HBc Total Final Interpretation by HBV Disease Classification: Pediatric Population (n=155)

| HBV Classification | PPA | | NPA | |
| --- | --- | --- | --- | --- |
| | % (n/N) | 95% CI | % (n/N) | 95% CI |
| Recovery | 100.0 (1/1) | (20.7-100.0%) | 0 (0/0) | N/A |
| Immune due to natural infection | 100.0 (2/2) | (34.2-100.0%) | 0 (0/0) | N/A |
| Immune due to HBV Vaccination | 0 (0/0) | N/A | 100.0 (56/56) | (93.6-100.0%) |
| Not Previously Infected | 0 (0/0) | N/A | 100.0 (95/95) | (96.1-100.0%) |
| Not interpretable/Unknown profilea | 0 (0/0) | N/A | 100.0 (1/1) | (20.7-100.0%) |
| Total | 100.0 (3/3) | (43.85-100.0%) | 100.0 (152/152) | (97.54-100.0%) |

a Samples were classified as "Not Interpretable" if their HBV seroprofile was predefined in the study protocol, and "Unknown" if not predefined. For data presentation, these are grouped as "Not Interpretable/Unknown", due to both groups having atypical seropatterns not aligning with HBV classification criteria.

Analytical comparison between pediatrics and adult samples spiked with anti-HBc Total. Thirty (30) samples from anti-HBc negative pediatric patients aged 2 to 21 were tested to determine if they provided equivalent results to anti-HBc negative adult human serum pool samples (controls) when samples were spiked with the same individual anti-HBc positive sample. Samples were spiked at a target anti-HBc value between 0.60 and 0.90 and tested with the Access Anti-HBc Total assay in replicates of three. The S/CO results for each pediatric sample were compared to the result obtained on each control sample and the difference between the pediatric sample and the control ranged from -0.052 to 0.165 S/CO.

Table 9. Percent Agreement between Access Anti-HBc Total and Comparator Anti-HBc Total Final Interpretation by HBV Disease Classification: Pregnant Population (n=171)

| HBV Classification | PPA | | NPA | |
| --- | --- | --- | --- | --- |
| | % (n/N) | 95% CI | % (n/N) | 95% CI |
| Recovery | 100.0 (2/2) | (34.2-100.0%) | 0 (0/0) | N/A |
| Chronic | 100.0 (1/1) | (20.7-100.0%) | 0 (0/0) | N/A |
| Immune due to HBV Vaccination | 0 (0/0) | N/A | 100.0 (86/86) | (95.7-100.0%) |
| Not previously infected | 0 (0/0) | N/A | 100.0 (82/82) | (95.5-100.0%) |
| Total | 100.0 (3/3) | 43.85-100.0% | 100.0 (168/168) | 97.76-100.0% |

Out of 171 specimens from pregnant subjects, 21 were from pregnant pediatrics. Comparison of Access Anti-HBc Total assay results to the reference results by trimester for the specimens is shown in the following Table.

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Table 10. Pregnant Subjects Performance by Trimester

| Trimester | Total | PPA | | NPA | |
| --- | --- | --- | --- | --- | --- |
| | | % (n/N) | 95% CI | % (n/N) | 95% CI |
| First | 71 | 100.0 (2/2) | 34.24 - 100.0 | 100.0 (69/69) | 94.73 - 100.0 |
| Second | 67 | 100.0 (1/1) | 20.65 - 100.0 | 100.0 (66/66) | 94.50 - 100.0 |
| Third | 33 | 0 (0/0) | N/A | 100.0 (33/33) | 89.57 - 100.0 |
| Overall | 171 | 100.0 (3/3) | 43.85 - 100.0 | 100.0 (168/168) | 97.76 - 100.0 |

Analytical comparison between pregnant and adult non-pregnant samples spiked with anti-HBc Total.

Thirty (30) samples from anti-HBc negative pregnant patients were tested to determine if they provided equivalent results to anti-HBc negative adult human serum pool samples (controls) when samples were spiked with the same individual anti-HBc positive sample. These 30 samples were approximately distributed between the first, second and third trimester of pregnancy. Samples were spiked at target anti-HBc values between 0.60 and 0.90 S/CO and tested with the Access Anti-HBc Total assay in replicates of three. The S/CO results for each pregnant sample were compared to the result obtained on each control sample and the difference between the pregnant sample and the control ranged from -0.165 to 0.141 S/CO.

Table 11. Comparison of Access Anti-HBc Total Versus Comparator in all Population by HBV Classification (Adult, Pregnant, and Pediatric)

| Cohort | Reference anti-HBc Total Assay | | | | Total |
| --- | --- | --- | --- | --- | --- |
| | Reactive | | Nonreactive | | |
| | Access anti-HBc Total | | Access anti-HBc Total | | |
| | Nonreactive (N) | Reactive (N) | Nonreactive (N) | Reactive (N) | |
| Acute | 0 | 1 | 2 | 0 | 3 |
| Recovery | 1 | 199 | 1 | 3 | 204 |
| Chronic | 3 | 93 | 0 | 0 | 96 |
| Immune due to natural infection | 3 | 121 | 0 | 0 | 124 |
| Immune due to HBV Vaccination | 0 | 0 | 834 | 11 | 845 |
| Not Previously Infected | 0 | 0 | 1,099 | 7 | 1,106 |
| Not interpretable/Unknown profilea | 0 | 7 | 4 | 0 | 11 |
| Missing test datab | 0 | 1 | 1 | 0 | 2 |
| Total | 7 | 422 | 1,941 | 21 | 2,391 |

a Samples were classified as "Not Interpretable" if their HBV seroprofile was predefined in the study protocol, and "Unknown" if not predefined. For data presentation, these are grouped as "Not Interpretable/Unknown", due to both groups having atypical seropatterns not aligning with HBV classification criteria.
b Samples were classified as "Missing Test Data" if insufficient volume was available to determine the HBV classification.

PPA and NPA by HBV classification for the study population is presented in the Table below.

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Table 12. Percent Agreement between Access Anti-HBc Total and Comparator by HBV Disease Classification in all Population (Adult, Pregnant, and Pediatric)

| HBV Classifications | Total | PPA % (N/N), [95% CI] | NPA % (N/N), [95% CI] |
| --- | --- | --- | --- |
| Acute | 3 | 100.0% (1/1) [20.65 - 100.0%] | 100.0% (2/2) [34.24 - 100.0%] |
| Recovery | 204 | 99.5% (199/200) [97.22- 99.91%] | 25.0% (1/4) [4.56 - 69.94%] |
| Chronic | 96 | 96.9% (93/96) [91.21 - 98.93%] | N/A |
| Immune due to natural infection | 124 | 97.6% (121/124) [93.13 - 99.17%] | N/A |
| Immune due to HBV Vaccination | 845 | N/A | 98.7% (834/845) [97.68 - 99.27%] |
| Not Previously Infected | 1,106 | N/A | 99.4% (1,099/1,106) [98.70 - 99.69%] |
| Not interpretable/Unknown profilea | 11 | 100.0% (7/7) [64.57 - 100.0%] | 100.0% (4/4) [51.01 - 100.0%] |
| Missing test datab | 2 | 100.0% (1/1) [20.65 - 100.0%] | 100.0% (1/1) [20.65 - 100.0%] |
| Overall | 2,391 | 98.4% (422/429) [96.67 - 99.21%] | 98.9% (1,941/1,962) [98.37 - 99.30%] |

a Samples were classified as "Not Interpretable" if their HBV seroprofile was predefined in the study protocol, and "Unknown" if not predefined. For data presentation, these are grouped as "Not Interpretable/Unknown", due to both groups having atypical seropatterns not aligning with HBV classification criteria.
b Samples were classified as "Missing Test Data" if insufficient volume was available to determine the HBV classification.

# 2. Matrix Comparison:

To verify equivalent performance between different matrices using the Access anti-HBc Total assay on the DxI 9000 Access Immunoassay Analyzer, 54 matched donor sets consisting of 9 specimen types each were evaluated. The results from the study demonstrate the equivalency between the reference sample type (serum without gel) and the 8 serum/plasma matrices evaluated (Table 13). The results support use of human serum [serum without gel and serum separator tubes (SST)], or plasma [lithium heparin, lithium heparin with gel, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, Acid Citrate Dextrose (ACD), and Citrate Phosphate Dextrose (CPD)] sample types.

Table 13. Regression Statistics for Matrix Comparison

| Tube Types | Slope | Intercept | r* |
| --- | --- | --- | --- |
| SST vs Serum no gel | 0.998 | -0.000 | 1.00 |
| Li Heparin no Gel vs Serum no gel | 1.015 | 0.004 | 1.00 |
| Li Heparin Gel vs Serum no gel | 1.016 | 0.008 | 1.00 |
| K2 EDTA vs Serum no gel | 0.985 | 0.013 | 1.00 |
| K3 EDTA vs Serum no gel | 0.999 | 0.016 | 1.00 |
| Na Citrate vs Serum no gel | 1.020 | -0.001 | 1.00 |
| ACD vs Serum no gel | 1.021 | -0.002 | 1.00 |
| CPD vs Serum no gel | 1.045 | 0.002 | 1.00 |

\*r: Correlation coefficient

# C Clinical Studies:

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1. Clinical Sensitivity:

N/A

2. Clinical Specificity:

N/A

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

N/A

# D Expected Values/Reference Range:

The Access anti-HBc Total results for the study population for all clinical trial sites combined by age group and sex are summarized in the Table below. Samples were considered reactive if S/CO was $&lt; 1.00$ upon testing and non-reactive if S/CO was $\geq 1.00$ .

Table 14. Expected Results of Access anti-HBc Total by Age and Sex

| Access anti-HBc Total | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Age Range (years) | Sex | Reactive | | Nonreactive | | Total |
| | | N | % | N | % | |
| 2-12 | Female | 0 | 0 | 6 | 100 | 6 |
| | Male | 0 | 0 | 11 | 100 | 11 |
| 13-18 | Female | 1 | 2.9 | 33 | 97.1 | 34 |
| | Male | 0 | 0 | 24 | 100 | 24 |
| 19-21 | Female | 0 | 0 | 73 | 100 | 73 |
| | Male | 2 | 7.1 | 26 | 92.9 | 28 |
| 22-29 | Female | 6 | 2.0 | 296 | 98.0 | 302 |
| | Male | 4 | 3.6 | 106 | 96.4 | 110 |
| 30-39 | Female | 8 | 2.9 | 270 | 97.1 | 278 |
| | Male | 18 | 13.4 | 116 | 86.6 | 134 |
| 40-49 | Female | 21 | 10.8 | 173 | 89.2 | 194 |
| | Male | 42 | 25.8 | 121 | 74.2 | 163 |
| 50-59 | Female | 64 | 23.6 | 207 | 76.4 | 271 |
| | Male | 105 | 42.9 | 140 | 57.1 | 245 |
| 60-69 | Female | 47 | 27.6 | 123 | 72.4 | 170 |
| | Male | 90 | 45.7 | 107 | 54.3 | 197 |
| 70-79 | Female | 15 | 26.3 | 42 | 73.7 | 57 |
| | Male | 15 | 25.0 | 45 | 75.0 | 60 |
| 80-89 | Female | 2 | 20.0 | 8 | 80.0 | 10 |

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| | Male | 3 | 16.7 | 15 | 83.3 | 18 |
| --- | --- | --- | --- | --- | --- | --- |
| 90+ | Female | 0 | 0 | 1 | 100 | 1 |
| | Male | 0 | 0 | 5 | 100 | 5 |
| Total | | 443 | 18.5 | 1,948 | 81.5 | 2,391 |

E Other Supportive Instrument Performance Characteristics Data:

Within-Assay Sample Carryover:
Testing was conducted to assess the sample-to-sample and sample-to-reagent pack carryover on the DxI 9000 Access Immunoassay Analyzer. Sample carryover testing was completed by running a sequence of alternating low (negative) and high anti-HBc serum samples. The acceptance criteria were met. Therefore, the Access anti-HBc Total assay is not susceptible to within-assay sample carryover.

Electrical safety and electromagnetic compatibility (EMC) testing were performed, and the system was found to be acceptable.

Software and cybersecurity documentation was reviewed and found to be acceptable.

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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