Access anti-HAV

K243846 · Beckman Coulter, Inc. · LOL · Sep 9, 2025 · Microbiology

Device Facts

• Record ID: K243846
• Device Name: Access anti-HAV
• Applicant: Beckman Coulter, Inc.
• Product Code: LOL · Microbiology
• Decision Date: Sep 9, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3310
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Access anti-HAV assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of total antibodies (anti-HAV IgG and IgM) to hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, sodium citrate, acid-citrate-dextrose (ACD), and citrate phosphate-dextrose (CPD)] using the Dxl 9000 Access Immunoassay Analyzer. The Access anti-HAV assay is indicated as an aid in the diagnosis of current or past HAV infection in persons with risk factors and/or signs or symptoms of hepatitis A, when used in conjunction with other serological and clinical information. The assay may also be used in the identification of HAV susceptible individuals and to determine the presence of an antibody response to HAV in vaccine recipients. This assay is not intended for use for screening donors of blood or blood products or human cells, tissues, or cellular or tissue-based products (HCT/Ps).

Device Story

Access anti-HAV is a two-step competitive chemiluminescent immunoassay performed on the DxI 9000 Access Immunoassay Analyzer. Patient serum or plasma samples are incubated with HAV antigen-coated paramagnetic particles; anti-HAV antibodies in the sample bind to the antigen. After washing, a monoclonal anti-HAV antibody alkaline phosphatase conjugate is added, competing with patient antibodies for the antigen. A second wash removes unbound materials, followed by the addition of a chemiluminescent substrate. The luminometer measures light production, which is inversely proportional to the amount of anti-HAV antibody in the sample. Results are compared to a stored cutoff value to provide a qualitative assessment. Used in clinical laboratories by trained personnel to aid in HAV diagnosis and vaccine response monitoring. Benefits include rapid, automated detection of HAV antibodies to support clinical decision-making.

Clinical Evidence

Clinical performance evaluated in a multi-center study (n=860: 760 prospective, 100 retrospective). Prospective cohort included patients with signs/symptoms of HAV (n=265) and increased risk (n=495). Adult PPA was 98.5% (472/479) and NPA was 98.9% (260/263). Pediatric PPA was 100% (101/101) and NPA was 100% (17/17). Vaccine response study (n=59) showed 100% seroconversion post-vaccination. Analytical sensitivity is 18 mIU/mL. No significant interference from common substances or cross-reactivity observed (except one HSV-1 sample).

Technological Characteristics

Paramagnetic particle-based competitive CLIA. Reagents: liquid ready-to-use. Analyte: total anti-HAV (IgG/IgM). Detection: luminometer. Calibration: 1-point (positive). Traceability: NIBSC 97/646. Compatible with serum, serum separator, and various plasma tubes (Li-Heparin, Na-Citrate, ACD, CPD). Software: DxI 9000 system-controlled, automated calibration evaluation and result interpretation.

Indications for Use

Indicated for pediatric (2-21 years) and adult patients with risk factors or signs/symptoms of hepatitis A to aid in diagnosis of current/past infection, identify HAV-susceptible individuals, and assess antibody response in vaccine recipients. Not for blood/tissue donor screening.

Regulatory Classification

Identification

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

Special Controls

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

Predicate Devices

• Elecsys Anti-HAV II (K190428)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number

K243846

B Applicant

Beckman Coulter Inc.

C Proprietary and Established Names

Access anti-HAV

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LOL, QCH | Class II | 21 CFR 866.3310 - Hepatitis A Virus (HAV) Serological Assays | MI - Microbiology |

## II Submission/Device Overview:

A Purpose for Submission:

Clearance for marketing of Access anti-HAV Assay, Access anti-HAV QC and Access Anti-HAV Calibrator.

B Measurand:

Total (IgG and IgM) antibodies to Hepatitis A Virus.

C Type of Test:

Chemiluminescent immunoassay (CLIA).

## III Intended Use/Indications for Use:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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# A Intended Use(s):

The Access anti-HAV assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of total antibodies (anti-HAV IgG and IgM) to hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, sodium citrate, acid-citrate-dextrose (ACD), and citrate phosphate-dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer.

The Access anti-HAV assay is indicated as an aid in the diagnosis of current or past HAV infection in persons with risk factors and/or signs or symptoms of hepatitis A, when used in conjunction with other serological and clinical information. The assay may also be used in the identification of HAV susceptible individuals and to determine the presence of an antibody response to HAV in vaccine recipients.

This assay is not intended for use for screening donors of blood or blood products or human cells, tissues, or cellular or tissue-based products (HCT/Ps).

# B Indication(s) for Use:

Same as intended use.

# 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-HAV assay is a two-step competitive immunoassay for the qualitative detection of total antibodies (anti-HAV IgG and IgM) to hepatitis A virus (HAV) using the DxI 9000 Access Immunoassay. It requires Access anti-HAV (reagent packs), Access anti-HAV Calibrator (C1), and Access anti-HAV QC (QC1-QC2). All reagents are provided in a liquid ready-to-use format. Each reagent kit contains two reagent packs. Calibrator contains one positive sample. Assay calibration can be performed when prompted by the DxI 9000 analyzer or when requested by the operator. Assay calibration data are automatically evaluated by the system, using acceptance criteria defined by the assay protocol file. The calibration acceptance criteria are automatically applied to the data and acceptance or rejection of data occurs without operator intervention. A current (or active) assay calibration is required for each assay that is to be performed.

QC kit contains 2 levels, positive and negative, three vials per level. The final QC value assignment is embedded in the barcode on the Access anti-HAV QC card provided with the QC kit. The analyte in the Access anti-HAV QC is traceable to the manufacturer's working

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calibrators. Traceability process is standardized to the Second International Reference Standard for Anti-Hepatitis A Immunoglobulin, Human (NIBSC: 97/646). Traceability process is based on EN ISO 17511.

Other items required to run the assay using the DxI 9000 Immunoassay analyzer include Lumi-Phos PRO substrate and UniCel DxI Wash Buffer II.

## B Principle of Operation:

Paramagnetic particles coated with hepatitis A virus antigen and sample are added to a reaction vessel. Anti-HAV antibodies in the patient sample bind to the coated antigen. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. A monoclonal anti-HAV antibody alkaline phosphatase conjugate is added to the reaction vessel and the conjugate competes with the bound patient antibodies to affix the HAV antigen coated on the particles. After a second incubation and a wash step, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is compared to the cut-off value defined during calibration. The qualitative assessment is automatically determined from a stored calibration. Results (Signal/Cutoff (S/CO)) are reported to be "reactive" or "nonreactive" as a function of their relationship with the "cutoff". When signal less than the cutoff the result is reported as "reactive", when signal is greater than or equal to the cutoff the result is reported as "nonreactive". Test results can be reviewed using the appropriate screen.

## Results interpretation:

Test results are determined automatically by the system software as follows.

≥ 1.00 S/CO Non-reactive

< 1.00 S/CO Reactive

## C Instrument Description Information:

1. Instrument Name:

DxI 9000 Immunoassay Analyzer

2. Specimen Identification:

Total (IgG and IgM) antibodies to Hepatitis A Virus 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, sodium citrate, acid-citrate-dextrose (ACD), and citrate phosphate-dextrose (CPD)]

4. Calibration:

Access anti-HAV Calibrator consists of 1 level (positive) provided as liquid ready-to-use

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5. Quality Control:

Access anti-HAV QC kit contains positive control and negative control as liquid ready-to-use

V Substantial Equivalence Information:

A Predicate Device Name(s):

Elecsys Anti-HAV II

B Predicate 510(k) Number(s):

K190428

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K243846 Candidate | K190428 Predicate |
| --- | --- | --- |
| Device Trade Name | Access anti-HAV | Elecsys Anti-HAV II |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The Access anti-HAV assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of total antibodies (anti-HAV IgG and IgM) to hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, sodium citrate, acid-citrate-dextrose (ACD), and citrate phosphate-dextrose (CPD)] using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HAV assay is indicated as an aid in the diagnosis of current or past HAV infection in persons with risk factors and/or signs or symptoms of hepatitis A, when used in conjunction with other serological and clinical information. The assay may also be used in the identification of HAV susceptible individuals and to determine the presence of an antibody response to HAV in vaccine recipients. This assay is not intended for use for screening donors of blood or blood | Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to hepatitis A virus (HAV) in human pediatric (ages 2 through 21 years) and adult serum and plasma (Li heparin, potassium EDTA, Na citrate, Na heparin). The assay, in conjunction with other serological and clinical information, is indicated as an aid in the clinical laboratory diagnosis of acute or past hepatitis A virus infection in persons with signs or symptoms of hepatitis and in persons at increased risk for hepatitis A infection, or as an aid to identify HAV susceptible individuals and to determine the presence of an antibody response to HAV in vaccine recipients. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e immunoassay analyzers. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. This |

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| | products or human cells, tissues, or cellular or tissue-based products (HCT/Ps). | assay has not been FDA cleared or approved for the screening of blood or plasma donors. |
| --- | --- | --- |
| Principle | Competitive CLIA | Competitive eCLIA (electro CLIA) |
| Analyte | aHAV IgM and IgG | aHAV IgM and IgG |
| Assay Type | Qualitative | Qualitative |
| Controls | 2 levels, 1 Positive, 1 Negative | 2 levels, 1 Positive, 1 Negative |
| Result interpretation | ≥ 1.00 S/CO Non-reactive
< 1.00 S/CO Reactive | COI > 1.0 Non-reactive
COI ≤ 1.0 Reactive |
| Reference standard (NIBSC code: 97/646) | Second International Standard for Anti-Hepatitis A, Immunoglobulin, Human, NIBSC code: 97/646 | Second International Standard for Anti-Hepatitis A, Immunoglobulin, Human, NIBSC code: 97/646 |
| General Device Characteristic Differences | | |
| Instruments | DxI 9000 | Cobas e 601 |
| Calibration Method | 1-point (positive), sold separately | 2-point (positive and negative), packed in kit |
| Matrices (compatible anticoagulants) | Serum, Serum separator tube, Plasma (Lithium Heparin, Lithium Heparin separator tube Sodium Citrate, Acid Citrate Dextrose (ACD), Citrate Phosphate Dextrose (CPD)) | Human serum, plasma (Li-Heparin, potassium EDTA, Na-Citrate, Na-Heparin) |
| Units | S/CO | COI (cutoff indices) |
| Volume of specimen needed | 55 uL | 20 uL |
| Time to result | 41 min | 18 min |
| Reagent On-board stability | 21 days | 8 weeks |
| Calibration frequency | 28 days | 8 weeks |

VI Standards/Guidance Documents Referenced:

1. Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays; 2006.
2. CLSI EP05-A3 (R2019): Evaluation of Precision of Quantitative Measurement Procedures; 2019.
3. CLSI EP07-A3: Interference Testing in Clinical Chemistry; 2018.

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4. CLSI EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples, Third Edition; 2018.
4. CLSI EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition; 2008.
5. CLSI EP24-A2: Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline – Second Edition; 2011.
6. CLSI EP25: Evaluation of Stability of In Vitro Medical Laboratory Reagents – Second Edition; 2023.
7. CLSI EP37: Supplemental Tables for Interference Testing in Clinical Chemistry – First Edition; 2018.
8. CLSI EP41, Collection of Diagnostic Venous Blood Specimens – Seventh Edition; 2017.
9. GP44-A4 (Formerly H18-A4): Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition; 2014.
10. ISO 15223-1: Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements – Fourth Edition; 2021.
11. 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.
12. IEC 62304: Medical device software - Software life cycle processes – Edition 1.1; 2015.
13. IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices Edition 1; 2015.

## VII Performance Characteristics (if/when applicable):

### A Analytical Performance:

1. **Precision/Reproducibility:**

A. Precision.

Within-laboratory precision of the Access anti-HAV assay was evaluated at one internal site on one Dxl 9000 Analyzer. 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 2 reagent pack lots and 2 calibrator lots. The precision study results are summarized in table 1.

Table 1: Within-laboratory precision study results

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B. Reproducibility.

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-HAV reagent pack, Access anti-HAV Calibrator, and Access anti-HAV QC. Samples were tested in 3 replicates per run, 2 runs per day, for 5 days. The reproducibility study results are summarized in table 2.

Table 2. Reproducibility study results

| | | | Between-Site | | Between-Day | | Between-Run | | Repeatability (Within-Run) | | 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 | 1.51 | 0.08 | 5.3 | 0.01 | 0.6 | 0.00 | 0.0 | 0.07 | 4.9 | 0.11 | 7.2 |
| S2 | 90 | 1.05 | 0.05 | 4.7 | 0.03 | 2.7 | 0.01 | 0.7 | 0.03 | 3.0 | 0.07 | 6.2 |
| S3 | 90 | 0.44 | 0.02 | 3.6 | 0.01 | 1.6 | 0.01 | 1.6 | 0.02 | 3.6 | 0.02 | 5.6 |
| S4 | 90 | 0.15 | 0.01 | 7.3 | 0.00 | 1.6 | 0.00 | 1.5 | 0.01 | 5.8 | 0.01 | 9.6 |
| P1 | 90 | 1.56 | 0.09 | 5.9 | 0.00 | 0.0 | 0.04 | 2.3 | 0.07 | 4.7 | 0.12 | 7.8 |
| P2 | 90 | 1.10 | 0.06 | 5.8 | 0.01 | 1.0 | 0.01 | 1.1 | 0.04 | 4.1 | 0.08 | 7.2 |
| P3 | 90 | 0.66 | 0.03 | 4.0 | 0.01 | 1.2 | 0.01 | 1.3 | 0.02 | 3.1 | 0.04 | 5.4 |
| P4 | 90 | 0.00 | 0.00 | N/A | 0.00 | N/A | 0.00 | N/A | 0.00 | N/A | 0.00 | N/A |

2. Linearity:

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N/A.

# 3. Analytical Specificity/Interference:

A. Cross-reactivity.

Potential cross-reactivity in the Access anti-HAV assay was evaluated using specimens with viral antibodies and from patients with related conditions. The anti-HAV total status of each specimen was verified using commercially available comparator anti-HAV Total assay. One out of twelve anti-HSV-1 IgG specimens was positive by Access anti-HAV but negative by the comparator assay. All other specimens were negative for anti-HAV by both assays. The cross-reactants, numbers of samples, and study results are summarized in table 3.

Table 3. Cross-reactivity of Access anti-HAV assay

| Category | Number of Samples Tested | Number of Reactive Samples by Access anti-HAV | Number of Non-Reactive Samples by Access anti-HAV |
| --- | --- | --- | --- |
| Viral Infections | | | |
| Cytomegalovirus (CMV) | 10 | 0 | 10 |
| Epstein-Barr Virus (EBV) | 10 | 0 | 10 |
| Herpes Simplex Virus-1 (HSV-1) | 12 | 1 | 11 |
| Herpes Simplex Virus-2 (HSV-2) | 10 | 0 | 10 |
| Toxoplasmosis | 12 | 0 | 12 |
| Viral Related Diseases | | | |
| Hepatitis B Virus (HBV) | 10 | 0 | 10 |
| Human Immunodeficiency Virus (HIV) | 15 | 0 | 15 |
| Hepatitis C Virus (HCV) | 10 | 0 | 10 |
| Varicella Zoster Virus (VZV) | 10 | 0 | 10 |
| Rubella | 12 | 0 | 12 |
| Measles | 11 | 0 | 11 |
| Mumps | 10 | 0 | 10 |
| Other Related Diseases | | | |
| Alcoholic Liver Disease (ALD) | 10 | 0 | 10 |
| Primary Biliary Cirrhosis (PBC) | 10 | 0 | 10 |
| Auto-Immune Diseases (Heterophile) | | | |
| Human Anti-Mouse Antibody (HAMA) | 11 | 0 | 11 |
| Anti-Nuclear Antibody (ANA) | 10 | 0 | 10 |
| Rheumatoid Factor (RF) | 13 | 0 | 13 |
| Systemic Lupus Erythematosus (SLE) | 13 | 0 | 13 |
| Multiple Myeloma | 10 | 0 | 10 |

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| Pregnant Women | | | |
| --- | --- | --- | --- |
| Pregnancy Multipara | 10 | 0 | 10 |
| Pregnancy First Trimester (T1) | 10 | 0 | 10 |
| Pregnancy Second Trimester (T2) | 10 | 0 | 10 |
| Pregnancy Third Trimester (T3) | 10 | 0 | 10 |

## B. Interference.

Potential interference of endogenous and exogenous substances was evaluated using three serum samples: negative for anti-HAV (≥1.25 S/CO), high negative (~1.1-1.3 S/CO) and low positive (~0.65-0.95 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 4.

| Potential interferent | Concentration tested |
| --- | --- |
| Hemoglobin | 1.0 g/dL |
| Total Protein | 15 g/dL |
| Bilirubin Conjugated | 43 mg/dL |
| Bilirubin Unconjugated | 43 mg/dL |
| Triglycerides Intralipids | 3,854 mg/dL (37 mmol/l) |
| Aspirin (acetylsalicylic acid) | 3.00 mg/dL (167 μmol/L) |
| Salicylic acid | 2.86 mg/dL (207 μmol/L) |
| Acetaminophen (paracetamol) | 15.6 mg/dL (1030 μmol/L) |
| Ibuprofen | 21.9 mg/dL (1060 μmol/L) |
| Atorvastatin | 0.075 mg/dL (1.34 μmol/L) |
| Lisinopril | 0.0246 mg/dL (0.607 μmol/L) |
| Levothyroxine | 0.0429 mg/dL (0.552 μmol/L) |
| Metformin | 1.20 mg/dL (92.9 μmol/L) |
| Amlodipine | 0.0075 mg/dL (0.183 μmol/L) |
| Omeprazole | 0.84 mg/dL (24.3 μmol/L) |
| Sertraline | 0.0927 mg/dL (3.03 μmol/L) |

## C. Hook effect.

To evaluate whether high levels of analyte in patient specimens cause hook effect, three specimens with S/CO below 0.1 were serially diluted to cover the assay range of S/CO values, and tested each with three reagent lots, in three replicates, on three instruments. No hook effect was observed for this assay.

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4. Assay Reportable Range: N/A (qualitative assay).

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

A. Stability (Controls, Reagent, Calibrator, Calibration Curve, Sample Handling). Stability studies supported the following stability claims.

| Study | Storage temperature | Supported claim |
| --- | --- | --- |
| QC Shelf-life | 2-10°C | 270 days |
| QC Open vial | 2-10°C | 90 days |
| Reagent Shelf-life | 2-10°C | 180 days |
| Reagent Open vial | 2-10°C | 21 days |
| Calibrator Shelf-life | 2-10°C | 180 days |
| Calibrator Open vial | 2-10°C | 125 days |
| Calibration curve | | 28 days |
| Sample stability | 25°C | 72 hours |
| | 2-10°C | 7 days |
| | Freeze/Thaw cycles | N=5 |

B) Fresh/frozen sample stability.

The equivalency of fresh and frozen samples was demonstrated using 56 serum samples. One aliquot of each sample was stored at 2-8°C and the other one was stored frozen at ≤ -18°C. The frozen aliquots were thawed and tested in parallel with the refrigerated samples. Passing-Bablok regression analysis was applied to evaluate the frozen sample results against the fresh sample results for all samples combined and for the reactive samples separately.

6. Detection Limit: (N/A)

7. Analytical Sensitivity:

A. Analytical sensitivity at cut-off.

The assay cut-off was evaluated using 118 positive and 65 negative patient specimens from individuals at risk for HAV infection and with signs and symptoms of HAV infection. The cut-off was set at 1.0 S/CO.

The concentration of the Second International Standard for Anti-Hepatitis A, Immunoglobulin (NIBSC Code: 97/64) at the assay cut-off was evaluated using serial dilutions of the international standard prepared in serum and plasma samples. Samples were tested with the Access anti-HAV assay for seven days, two runs per day using 3 lots of calibrator and 3 lots of reagents. Regression analysis demonstrated the concentration at the assay cutoff (1.00 S/CO) was 18.0 mIU/mL.

B. Seroconversion.

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Seroconversion sensitivity of the Access anti-HAV was evaluated in comparison to a commercially available anti-HAV assay using four seroconversion panels obtained from commercial vendors. For each panel, the number of days to the first reactive result was the same between the comparator and the candidate assay. The results are summarized in table 5.

Table 5. Seroconversion sensitivity results

| | First anti-HAV positive result from initial draw date | | Access anti-HAV vs reference assay |
| --- | --- | --- | --- |
| Panel ID | Access anti-HAV (days) | Reference assay (days) | Difference in bleed number for the first reactive bleed |
| 0615-0026 | 10 | 10 | 0 |
| HAV002SCP | 109 | 109 | 0 |
| HAV003SCP | 56 | 56 | 0 |
| SCP-HAV-002 | 5 | 5 | 0 |

# 8. Within-assay carryover.

To evaluate within-assay carryover, alternating high positive and negative samples were tested in multiple runs using the Access anti-HAV assay. None of the results from negative sample obtained after testing a positive sample became positive.

# B Comparison Studies.

# 1. Method Comparison.

The assay performance was evaluated using a total of 860 patient specimens from cohorts summarized in table 6. Composite Reference Method (CRM) was used to determine the comparator anti-HAV status. Serum samples were tested at three sites by the Access anti-HAV and at one of the sites on the comparator devices. The agreement results for all cohorts and performance for adult and pediatric populations separately are summarized in tables 6-8.

Table 6. Access anti-HAV test agreements with CRM for all cohorts.

| Cohort/Patient Category | Reference anti-HAV CRM | | | | Total |
| --- | --- | --- | --- | --- | --- |
| | Nonreactive | | Reactive | | |
| | Access anti-HAV | | | | |
| | Nonreactive | Reactive | Nonreactive | Reactive | |
| Adult at-risk for HAV infection (prospective) | 165 | 2 | 2 | 219 | 388 |
| Adult with signs and symptoms (prospective) | 95 | 1 | 5 | 163 | 264 |
| Acute adult (retrospective) | 0 | 0 | 0 | 90 | 90 |
| Pediatric | 17 | 0 | 0 | 101 | 118 |
| Total | 277 | 3 | 7 | 573 | 860 |

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Table 7. Anti-HAV performance for adult population.

| Patient Category | NPA | | PPA | |
| --- | --- | --- | --- | --- |
| | % (n/N) | 95% CI | % (n/N) | 95% CI |
| Adult at-risk for HAV infection | 98.8 (165/167) | 95.7-99.7 | 99.1 (219/221) | 96.8-99.8 |
| Adult with signs and symptoms | 99.0 (95/96) | 94.3-99.8 | 97.0 (163/168) | 93.2-98.7 |
| Acute | N/A | N/A | 100.0 (90/90) | 95.9-100.0 |
| Overall | 98.9 (260/263) | 96.7-99.6 | 98.5 (472/479) | 97.0-99.3 |

Table 8. Anti-HAV performance for pediatric population.

| Patient Category | NPA | | PPA | |
| --- | --- | --- | --- | --- |
| | % (n/N) | 95% CI | % (n/N) | 95% CI |
| Pediatric at-risk/with signs and symptoms (prospective) | 100.0 (17/17) | 81.6-100.0 | 100.0 (91/91) | 95.9-100.0 |
| Acute pediatric (retrospective) | N/A | N/A | 100.0 (10/10) | 72.2-100.0 |
| Overall | 100.0 (17/17) | 81.6-100.0 | 100 (101/101) | 96.3-100.0 |

# Vaccine Study

A cohort of specimens collected pre- and post-HAV vaccination was evaluated using CRM and Access anti-HAV assay. Three HAV vaccines currently licensed in the U.S. were used in the study. Post-vaccination specimens were collected four to ten weeks after the complete vaccination was administered according to vaccine dosing instructions. The combined agreement results are summarized in table 9.

Table 9. Access anti-HAV test agreements with CRM for the vaccination cohort.

| Vaccine | anti-HAV CRM | | | | Total | |
| --- | --- | --- | --- | --- | --- | --- |
| | | Reactive | | Nonreactive | | |
| | | Access anti-HAV | | | | |
| | | Reactive | Nonreactive | Reactive | | Nonreactive |
| HAVRIX | Pre-vaccination | 0 | 0 | 0 | 22 | 22 |
| | Post-vaccination | 22 | 0 | 0 | 0 | 22 |
| TWINRIX | Pre-vaccination | 0 | 0 | 0 | 21 | 21 |
| | Post-vaccination | 21 | 0 | 0 | 0 | 21 |
| VAQTA | Pre-vaccination | 0 | 0 | 0 | 16 | 16 |
| | Post-vaccination | 16 | 0 | 0 | 0 | 16 |

# 2. Matrix Comparison:

To verify equivalent performance between different matrices, 65 native specimens were analyzed, 25 of which were negative and 40—positive, with S/CO values distributed along the measuring range. Each specimen was collected in all 7 types of tubes listed in the intended use and compared with serum without gel (reference matrix). Results are summarized in table 9.

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Table 9. Matrix comparison study results.

| | Sample type vs Reference (Serum no gel) | | |
| --- | --- | --- | --- |
| | Slope | 95% Interval Slope | Correlation coefficient (r) |
| Serum gel | 1.00 | 0.99 - 1.01 | 1.00 |
| Li Heparin | 1.01 | 0.99 - 1.04 | 1.00 |
| Li Heparin + gel | 1.02 | 1.00 - 1.03 | 1.00 |
| Na Citrate | 1.01 | 0.99 - 1.03 | 1.00 |
| ACD | 1.01 | 0.99 - 1.03 | 1.00 |
| CPD | 1.01 | 0.99 - 1.03 | 1.00 |

# C Clinical Studies:

1. Clinical Sensitivity:

N/A

2. Clinical Specificity:

N/A

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

N/A

# 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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