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

Intended 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

February 19, 2026

Beckman Coulter, Inc.
Fatima Pacheco
Staff Regulatory Affairs Specialist
1000 Hazeltine Dr.
Chaska, Minnesota 55318

Re: K253687
Trade/Device Name: Access anti-HBc Total
Regulation Number: 21 CFR 866.3173
Regulation Name: Hepatitis B virus antibody assays
Regulatory Class: Class II
Product Code: SEI
Dated: November 21, 2025
Received: November 21, 2025

Dear Fatima Pacheco:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253687 - Fatima Pacheco
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K253687 - Fatima Pacheco
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Uwe Scherf -S

Uwe Scherf, M.Sc., Ph.D.
Director
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253687 | |
| Device Name Access anti-HBc Total | |
| Indications for Use (Describe) 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. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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BECKMAN COULTER

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K253687
Date Prepared: February 18, 2026

## Submitter Name and Address:
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska, MN 55318

## Primary Contact:
Fatima Pacheco
Staff Regulatory Affairs
Email: [e-mail]

## Device Trade Name:
Access anti-HBc Total

## Common Name:
Qualitative and Quantitative Hepatitis B virus antibody assays

## Classification Regulation:
21 CFR 866.3173

## Class:
II

## Classification Product Code:
SEI

## Predicate Device
Device Name: ARCHITECT CORE
510(k) Numbers: P080023

## Purpose for Submission:
New device market clearance of Access anti-HBc Total assay for use on the Dxl 9000 Immunoassay Analyzer

## Device Description

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). The Access anti-HBc Total assay is a two-step competitive immunoassay. 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.

Access anti-HBc Total 510(k) Summary
Page 1 of 14

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Quality control (QC) materials simulate the characteristics of patient samples and are essential for monitoring the system performance of the Access anti-HBc Total immunoassay. In addition, they are an integral part of good laboratory practices. When performing assays with Access reagents for anti-HBc Total, include quality control materials to validate the integrity of the assay. The assayed values should fall within the acceptable range if the test system is working properly.

The Access anti-HBc Total reagents are provided in liquid ready-to-use format designed for optimal performance on the Beckman Coulter DxI 9000 Access Immunoassay Analyzer only. Each reagent kit contains two reagent packs. The Access anti-HBc Total Calibrator kit contains one vial, and the Access anti-HBc Total QC kit contains three vials, each of anti-HBc total positive control and anti-HBc total negative control. Other items needed to run the assay include Lumi-Phos PRO (chemiluminescent substrate) and UniCel DxI Wash Buffer II.

## Intended 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.

## Substantial Equivalence Information

The Access anti-HBc Total and ARCHITECT CORE reagents employ prepackaged reagents for use on automated test systems. A comparison of the key device features, including similarities and differences of these assays, is shown in the following table.

Access anti-HBc Total 510(k) Summary
Page 2 of 14

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Comparison Table

| Features / Characteristics | Candidate Device
Access anti-HBc Total | Primary Predicate (P080023)
ARCHITECT CORE | Comment |
| --- | --- | --- | --- |
| Reagent Intended Use and Clinical Indications | 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 Dxl 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 Dxl 9000 Access Immunoassay Analyzer only.
This assay is not intended for the screening of blood, plasma, and cell or tissue donors. | 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. | Similar |
| Calibrator and QC Intended Use | 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 Dxl 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 Dxl 9000 Access Immunoassay Analyzer. | 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. | Similar |
| Operating Principle | Two-step competitive | Two-step immunoassay | Similar |
| Analyte Measured | anti-HBc | Same | Same |
| Assay Type | Qualitative | Same | Same |
| Detection Method | Automated, Chemiluminescence | Automated, CMIA | Similar |

Access anti-HBc Total 510(k) Summary

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Access anti-HBc Total 510(k) Summary
Page 4 of 14

| Features / Characteristics | Candidate Device Access anti-HBc Total | Primary Predicate (P080023) ARCHITECT CORE | | | Comment |
| --- | --- | --- | --- | --- | --- |
| Reagent, Calibrator, and QC format | Liquid, ready to use | Same | | | Same |
| Calibrator(s) | 1-level C1 (positive) | 2 levels Calibrator 1 (positive) | | | Same |
| Control(s) | 2-levels 1 Negative, 1 Positive | 2-levels 1 Negative Control, 1 Positive Control | | | Same |
| Sample Type | Serum and Plasma | Same | | | Same |
| Compatible Anticoagulants | 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)] | Human serum, plasma (dipotassium EDTA, Lithium Heparin, Sodium Heparin) | | | Similar |
| Sample Volume | 105 μL | 75 μL | | | Different |
| Instrumentation | Dxl 9000 Access Immunoassay Analyzer | ARCHIECT i Systems | | | Different |
| Test Result Reporting | ≥ 1.00 S/CO Non-reactive < 1.00 S/CO Reactive | Initial Results | | | Different |
| | | Initial Result (S/CO) | Interpretation | Retest Procedure | |
| | | < 0.80 | Nonreactive | No retest required. | |
| | | 0.80 to < 1.21 | Grayzone | Retest same specimen in duplicate. | |
| | | > 1.21 | Reactive | Retest same specimen in duplicate. | |
| | | Final Interpretation | | | |
| | | Initial Interpretation | Results with Retest | Final Interpretation | |
| | | Nonreactive | No retest required | Nonreactive | |
| | | Grayzone | If 2 of 3 results are < 1.00 S/CO | Nonreactive | |
| | | | If 2 of 3 results are ≥ 1.00 S/CO | Reactive | |
| | | Reactive | If both retest results are < 1.00 S/CO | Nonreactive | |

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Access anti-HBc Total 510(k) Summary
Page 5 of 14

| Features / Characteristics | Candidate Device Access anti-HBc Total | Primary Predicate (P080023) ARCHITECT CORE | | | Comment |
| --- | --- | --- | --- | --- | --- |
| | | | If 2 of 3 of the results are ≥ 1.00 S/CO | Reactive | |
| Traceability/ Standardization | Calibrator is traceable to the manufacturer's working calibrator. | ARCHITECT CORE Calibrator is standardized against the reference standard of the Paul Ehrlich Institute Germany. | | | Same |
| Time to Result | ~ 36 minutes | ~ 29 minutes | | | Different |
| Reagent Storage and Stability | Unopened at 2 to 10°C up to stated expiration date | Unopened at 2 to 8°C up to stated expiration date | | | Similar |
| Reagent In-use (On-board) Stability | 45 days | 30 days | | | Different |
| Calibration Frequency | 56 days | 30 days | | | Different |

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# Summary of Studies

# Clinical Performance

# Expected Results

The US study population represented $58.8\%$ White, $26.1\%$ Black or African American, $4.2\%$ Asian, $1.8\%$ American Indian or Alaska Native, $0.2\%$ Native Hawaiian or other Pacific Islander, and $8.9\%$ from unknown/other or unwilling to answer. $33.2\%$ of the prospective study population was of Hispanic ethnicity. The majority of patients were female (58.4% female and 41.6% male) from the following states: Arizona (585, 24.5%), California (118, 4.9%), Connecticut (125, 5.2%), Florida (304, 12.7%), Georgia (61, 2.6%), Idaho (71, 3.0%), Minnesota (68, 2.8%), North Carolina (1, 0.0%), New Jersey (91, 3.8%), New York (444, 18.6%), Ohio (8, 0.3%), Pennsylvania (58, 2.4%), South Carolina (33, 1.4%), Tennessee, (39, 1.6%), Texas (380, 15.9%), and Virginia (5, 0.2%). Each sample was tested at one of three clinical sites located in Minneapolis, MN; Louisville, KY; or Baltimore, MD using the Access anti-HBc Total assay and a commercially available anti-HBc Total assay.

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 $\geq 1.00$ .

Distribution of Access anti-HBc Total Reactive and Nonreactive Results by Age Range 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 |
| | Female | 2 | 20.0 | 8 | 80.0 | 10 |

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| Access anti-HBc Total | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Age Range (years) | Sex | Reactive | | Nonreactive | | Total |
| | | N | % | N | % | |
| 80-89 | 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 |

## Method Comparison

A multi-center study was conducted using the Dxl 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 population included 2,391 prospectively collected specimens. Of the 2,391 specimens collected, 2,065 were from non-pregnant adults classified as increased risk for hepatitis due to lifestyle, behavior, occupation, or known exposure events, or individuals with signs and symptoms of hepatitis. 171 prospective specimens were from the pregnant population with increased risk and/or showed signs and symptoms of hepatitis. Specimens from the pregnant population included 71 from the first trimester, 67 from the second trimester, and 33 from the third trimester. In addition, 155 were pediatric (2 - 21 years) specimens with increased risk and/or sign &amp; symptoms. The table below summarizes the number of specimens in each population.

| Cohort | Adult (Non-Pregnant) | Pregnant | Pediatric (Non-Pregnant) |
| --- | --- | --- | --- |
| | IR/S&S* (N) | IR/S&S (N) | IR/S&S (N) |
| Total (n=2,391) | 2,065 | 171 | 155 |

*IR/S&amp;S =Increased Risk and/or Signs &amp; Symptoms

## Comparison of Results HBV Classification Category

Access anti-HBc Total results for each HBV classification were compared with the final interpretation from the reference anti-HBc Total assay used for classification. The results for the intended use population are described in the table below.

| Cohort | Reference anti-HBc Total | | | | Total (N) |
| --- | --- | --- | --- | --- | --- |
| | Reactive | | Nonreactive | | |
| | Access anti-HBc Total | | | | |
| | Nonreactive | Reactive | Nonreactive | Reactive | |
| | (N) | (N) | (N) | (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 |

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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.

Positive percent agreement and negative percent agreement between the Access anti-HBc Total assay and the reference assay final interpretation for the intended use population is summarized in the following table.

| Total | PPA | | NPA | |
| --- | --- | --- | --- | --- |
| | % (n/N) | 95% CI | % (n/N) | 95% CI |
| 2,391 | 98.4 (422/429) | 96.67 - 99.21 | 98.9 (1,941/1,962) | 98.37 - 99.30 |

Comparison of Results - Overall Signs and Symptoms Population

| Access anti-HBc Total | Reference anti-HBc Total assay | | Total (N) |
| --- | --- | --- | --- |
| | Nonreactive (N) | Reactive (N) | |
| Nonreactive | 163 | 1 | 164 |
| Reactive | 3 | 54 | 57 |
| Total | 166 | 55 | 221 |

- % Positive Agreement = 98.2% (54/55), 95% Confidence Interval = 88.66% to 99.62%
- % Negative Agreement = 98.2% (163/166), 95% Confidence Interval = 94.82% to 99.38%

Comparison of Results - Overall Increased Risk Prospective Population

| Access anti-HBc Total | Reference anti-HBc Total assay | | Total (N) |
| --- | --- | --- | --- |
| | Reactive (N) | Nonreactive (N) | |
| Reactive | 368 | 18 | 386 |
| Nonreactive | 6 | 1,778 | 1,784 |
| Total | 374 | 1,796 | 2,170 |

- % Positive Agreement = 98.4% (368/374), 95% Confidence Interval = 96.54% to 99.26%
- % Negative Agreement = 99.0% (1,778/1,796), 95% Confidence Interval = 98.42% to 99.37%

# Comparison of Results for Pregnant Women by Trimester

171 serum samples were prospectively collected from a pregnant population with risk factors and/or signs and symptoms of hepatitis B. Samples were tested using the Access anti-HBc Total assay and the reference anti-HBc Total assay. The results of anti-HBc Total testing at all sites combined by age group is presented in the following table.

| Age Group | Trimester | Reference anti-HBc Total assay | |
| --- | --- | --- | --- |
| | | Reactive | Nonreactive |
| | | Access anti-HBc Total | |
| | | Reactive (N) | Nonreactive (N) |
| ≤ 21 years | First | 0 | 12 |
| | Second | 0 | 5 |

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| Age Group | Trimester | Reference anti-HBc Total assay | |
| --- | --- | --- | --- |
| | | Reactive | Nonreactive |
| | | Access anti-HBc Total | |
| | | Reactive (N) | Nonreactive (N) |
| | Third | 0 | 4 |
| >21 years | First | 2 | 57 |
| | Second | 1 | 61 |
| | Third | 0 | 29 |
| Total | | 3 | 168 |

The positive percent agreement and negative percent agreement between the Access anti-HBc Total assay and the reference anti-HBc Total assay for the pregnant women population is summarized in the following table. This population included 21 pregnant subjects of pediatric age range (18 – 21 years).

| 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 | N/A | 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 |

## Comparison of Results for Pediatric Population

155 serum samples were prospectively collected from a pediatric (non-pregnant) population (2 - 21 years) with risk factors and/or signs and symptoms. Samples were tested using the Access anti-HBc Total assay and the reference anti-HBc Total assay. The results of anti-HBc Total testing are presented in the following table.

| Access anti-HBc Total | Reference anti-HBc Total assay | | Total (N) |
| --- | --- | --- | --- |
| | Reactive (N) | Nonreactive (N) | |
| Reactive | 3 | 0 | 3 |
| Nonreactive | 0 | 152 | 152 |
| Total | 3 | 152 | 155 |

- % Positive Agreement = 100.0% (3/3), 95% Confidence Interval = 43.85% to 100.0%
- % Negative Agreement = 100.0% (152/152), 95% Confidence Interval = 97.54% to 100.0%

## Seroconversion

Seven 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 the table below.

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| Panel ID | First anti-HBc Total positive result from initial draw date | | Access anti-HBc Total vs. Reference assay |
| --- | --- | --- | --- |
| | Access anti-HBc Total (days) | Reference assay (days) | Difference in bleed number from 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.

## Imprecision

The imprecision of the Access anti-HBc Total assay was evaluated in a study based on CLSI EP05-A3 guideline. The study design included two test runs per day over a minimum of 20 test days. A ten-member panel of serum (S1-S4) and plasma (P1-P4) patient samples and the two Access anti-HBc Total QC were assayed in each run in triplicate. Three lots each of Access anti-HBc Total reagent, two lots of Access anti-HBc Total Calibrator were tested on three Dxl 9000 Access Immunoassay Analyzers. The results are summarized in the following table.

| Sample | N | Mean (S/CO) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Between-Reagent Lot | | Between-Instrument | | Within Laboratory (overall) | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | 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.

## Reproducibility

A 5-day reproducibility study was performed on the Dxl 9000 Access Immunoassay analyzer based on CLSI EP05-A3 guideline. An eight-member panel of patient samples, including serum and plasma samples, were assayed at three clinical sites, using one lot of Access anti-HBc Total reagent kit, on three

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instruments (one instrument per site). Each panel member was assayed in replicates of three at two separate times per day. The results are summarized in the following table.

| | | | Repeatability Within Run | | Between Run | | Between Day | | Between Site | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean (S/CO) | 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 approached zero. Results are noted as N/A.

## Interfering Substances

Testing was performed using two negative samples (one low negative and one high negative) and one reactive (one low positive) sample with substances at the concentrations indicated. Of the compounds tested, none were found to cause interference using the highest test concentrations indicated in the table below.

| Potential Interferent | Highest Concentration Added |
| --- | --- |
| 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 |
| 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 |

The Access anti-HBc Total assay does not utilize biotin-streptavidin chemistry; as a result, it is not susceptible to biotin interference.

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# Cross Reactivity

A total of 280 samples were tested for anti-HBc Total cross-reactivity categories on both the Access anti-HBc Total assay and reference device. The Access anti-HBc Total assay results for cross-reactivity study demonstrate no cross reactivity on the Dxl 9000 Access Immunoassay. The results are summarized in the following table.

| Category | Number of samples tested | Number of Reactive samples | Number of Nonreactive samples |
| --- | --- | --- | --- |
| Epstein-Barr virus (EBNA IgG or VCA IgG) | 10 | 0 | 10 |
| Cytomegalovirus (CMV) | 10 | 0 | 10 |
| Herpes simplex Virus-1 (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 |
| 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 (including E. coli urinary infection) | 10 | 0 | 10 |
| Rubella | 10 | 0 | 10 |
| Varicella Zoster Virus (VZV) | 10 | 0 | 10 |
| Measles | 10 | 0 | 10 |
| Mumps | 10 | 0 | 10 |

# Analytical Sensitivity

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

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This study aimed at finding the minimum analyte level (IU/mL) that scientists were still able to detect the antibody in one sample. The analytical sensitivity was determined as the intersection point of fitted model and S/CO value being 1.00. The maximum overall analytical sensitivity results determined in this study are summarized in the following table.

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

## Matrix Equivalence

A matrix equivalence study was performed using a protocol based on CLSI EP09c, 3rd Edition. Matched donor sets consisting of nine specimen types each were used for the evaluation. Serum (without gel) served as the reference sample type. The results from the study demonstrate the equivalency between the reference sample type, serum (without gel) and the eight serum/plasma matrices evaluated. The results support use of human serum (without gel), serum separator tubes, 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.

## Sample Stability

### Sample Handling Stability

Sample handling and freeze/thaw stability was established for the Access anti-HBc Total assay on the Dxl 9000 Access Immunoassay Analyzer.

The study verified the following sample handling claims.

- Up to 72 hours when stored at 20-25°C
- Up to 7 days when stored at 2-8°C
- Up to 30 days, thaw samples no more than 4 times when stored at ≤ -20°C or colder.

## Reagent Stability Studies

Access anti-HBc Total reagents shelf-life dating was established based on real time stability (RTS) studies for the Access anti-HBc Total reagent pack, Access anti-HBc Total Calibrator, and Access anti-HBc Total QC. The studies were performed to determine the shelf-life at the recommended storage condition (2-10°C), using a protocol based on CLSI EP25-ED2 guideline.

In-use studies were also performed using a protocol based on CLSI EP25-ED2 guideline. Each study included evaluation stability following simulated winter and summer transport stresses on the reagent packs, Calibrator, and QC.

## Intra-Assay Carryover

Testing was conducted to assess the sample-to-sample and sample-to-reagent pack carryover on the Access anti-HBc Total assay. Test procedures were based on CSI EP10-A3 AMD guideline. No intra-assay carryover was observed with the Access anti-HBc Total assay tested on the Dxl 9000 Access Immunoassay Analyzer.

## Hook Effect

A hook study was performed to evaluate if high levels of analyte in patient specimens result in a hook effect that changes the reported results of the Access anti-HBc Total assay on the Dxl 9000 Access Immunoassay Analyzer. The study was performed using a ten-dilution series originating from three anti-HBc Total positive samples. No hook effect (no change in result interpretation) was observed for this assay.

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# Substantial Equivalence Comparison Conclusion

The results of the non-clinical analytical and clinical performance studies demonstrate that the Beckman Coulter Access anti-HBc Total assay for use on the Dxl 9000 Access Immunoassay Analyzer is as safe, as effective, and performs as well as the predicate device.