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510(k) Data Aggregation
(30 days)
LIAISON Anti-HAV; LIAISON XS
The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family*. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients.
This assay is not intended for screening blood or solid or soft tissue donors.
The DiaSorin LIAISON® XS Analyzer is a fully automated, closed, continuous loading of samples and reagents in vitro diagnostic immunoassay system utilizing chemiluminescent technology to provide rapid sample results. The analyzer uses DiaSorin proprietary reagents in which chemiluminescence of an analyte is measured in a sample by the reaction of a magnetic particle solid phase coated with antigen or antibody and a chemiluminescent tracer. The LIAISON® XS Analyzer is intended for use in professional clinical laboratories only.
The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. The assay uses magnetic particles (solid phase) coated with IgG antibodies to HAV (mouse monoclonal), and a mouse monoclonal anti-HAV antibody conjugate linked to an isoluminol derivative (isoluminolantibody conjugate).
The provided text describes a 510(k) premarket notification for a modified medical device, the LIAISON® XS Analyzer, used with the LIAISON® Anti-HAV assay. However, the document does not contain specific details about acceptance criteria, reported device performance (in terms of sensitivity, specificity, etc.), sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for either test or training sets.
The submission is for a device modification (moving fluid canisters onboard) to an already cleared device (K210272). The focus of the provided text is on demonstrating that these modifications do not negatively impact the device's performance or safety/effectiveness, rather than a full de novo performance study of the Anti-HAV assay itself.
Therefore, most of the requested information cannot be extracted from this document. The "Summary of Performance Data" section states that "Non-clinical verification and validation activities conducted with the LIAISON® XS Analyzer demonstrate that the modified device met predetermined acceptance criteria," but it does not specify what those criteria were or quantitatively report the performance. It merely lists the types of studies conducted.
Here is what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list the acceptance criteria or quantitative performance results (e.g., sensitivity, specificity, accuracy) for the LIAISON Anti-HAV assay after the modifications. It broadly states: "Non-clinical verification and validation activities conducted with the LIAISON® XS Analyzer demonstrate that the modified device met predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device." And "Testing verified all acceptance criteria were met."
The primary goal of this 510(k) is to demonstrate that the modifications to the analyzer (moving fluid canisters onboard) do not alter the safety and effectiveness of the existing cleared device. The previous clearance (K210272) would have contained the detailed performance data for the LIAISON® Anti-HAV assay itself.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in this document. The document refers to "non-clinical verification and validation activities" which are typically internal testing, not necessarily clinical studies with patient test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable and not provided. This information would be relevant for a de novo clinical study with expert ground truth, which is not the focus of this modification submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The LIAISON® XS Analyzer is an in vitro diagnostic immunoassay system, not an AI-assisted diagnostic tool that requires human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The LIAISON® Anti-HAV assay on the LIAISON® XS Analyzer is a standalone diagnostic test. Its performance is evaluated based on its accuracy in detecting antibodies, as indicated by the chemiluminescence signal, and does not involve human interpretation of complex images or signals in the same way an AI algorithm might. The document does not provide the specific performance metrics (e.g., sensitivity, specificity, NPV, PPV) for this standalone device in the context of this specific 510(k) submission, as it refers to these having been established in the previous clearance (K210272).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated in this specific document. For an immunoassay like this, the ground truth for clinical studies would typically be established through a combination of:
- Established reference methods: Usually another FDA-cleared or gold standard HAV antibody test.
- Clinical diagnosis: Based on patient symptoms, epidemiological information, and other laboratory markers.
- Seroconversion panels: Well-characterized samples from individuals demonstrating progression of infection or immune response.
Since this 510(k) is for a modification to an existing device, it relies on the ground truth established during the original clearance of the LIAISON® Anti-HAV assay.
8. The sample size for the training set
Not applicable and not provided. Immunoassays are not "trained" in the same way machine learning models are. Performance characteristics are established through various analytical and clinical studies.
9. How the ground truth for the training set was established
Not applicable and not provided (see point 8).
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(8 days)
LIAISON Anti-HAV
The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients.
This assay is not intended for screening blood or solid or soft tissue donors.
The DiaSorin LIAISON® XS Analyzer is a fully automated, closed, continuous loading of samples and reagents in vitro diagnostic immunoassay system utilizing chemiluminescent technology to provide rapid sample results. The analyzer uses DiaSorin proprietary reagents in which chemiluminescence of an analyte is measured in a sample by the reaction of a magnetic particle solid phase coated with antigen or antibody and a chemiluminescent tracer. The LIAISON® XS Analyzer is intended for use in professional clinical laboratories only.
The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. The assay uses magnetic particles (solid phase) coated with IgG antibodies to HAV (mouse monoclonal), and a mouse monoclonal anti-HAV antibody conjugate linked to an isoluminol derivative (isoluminol-antibody conjugate).
The information provided pertains to the DiaSorin LIAISON® Anti-HAV assay running on the LIAISON® XS Analyzer. This premarket notification is a "Special 510(k)" for device modifications to the existing LIAISON® XS analyzer (K193532), primarily addressing improvements in reliability related to the reagent pipettor. The LIAISON® Anti-HAV assay component and procedures themselves remain unchanged.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance criteria | Reported Device Performance | Acceptance criteria met? |
|---|---|---|---|
| Analytical Sensitivity, as concentration at cut off threshold vs WHO standard preparation | Analytical sensitivity in the range 15.5 - 21.5 mIU/ml | Run 1: 21 mIU/mL | |
| Run 2: 20 mIU/mL | Yes | ||
| Total precision, as value of the percentage coefficient of variation (CV) | ≤14.5% | 3.3 - 7.2% | Yes |
| Positive agreement | ≥95% | 97.0% | Yes |
| Negative agreement | ≥95% | 98.2% | Yes |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set for the immunometrical performance assessment.
- Data Provenance: Not specified. It's unclear if the data is retrospective or prospective, or the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of in vitro diagnostic device (immunoassay). Ground truth for these assays is typically established by reference methods or clinical diagnosis, not by experts reviewing images or other data.
4. Adjudication method for the test set
Not applicable for this type of in vitro diagnostic device. Result determination is quantitative or qualitative based on the assay's output measurements against a defined cutoff, not through expert adjudication of individual cases.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging devices or AI-assisted diagnostic tools where human readers interpret results. The LIAISON® Anti-HAV assay is an automated chemiluminescent immunoassay.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance presented in Table 6-3 represents the standalone performance of the LIAISON® Anti-HAV assay on the modified LIAISON® XS Analyzer. This device is an automated immunoassay system, and its output is directly interpreted as a qualitative detection of antibodies.
7. The type of ground truth used
The ground truth for the immunometrical performance assessment:
- Analytical Sensitivity: Established against a "WHO standard preparation."
- Positive/Negative Agreement: Implied to be established against a reference method or clinical diagnosis for Hepatitis A infection, as is standard for serological assays. The document does not explicitly name the specific reference method used for establishing positive and negative agreement.
8. The sample size for the training set
The document does not provide information regarding a separate "training set" or its sample size. For an immunoassay like this, the development likely involves optimization and validation steps, but not a distinct "training set" in the machine learning sense. The performance data presented is for the evaluation of the validated device.
9. How the ground truth for the training set was established
As there is no explicit mention of a training set in the context of machine learning, there is no information on how its ground truth was established. The development of such an assay involves careful analytical and clinical validation, ensuring its performance aligns with established diagnostic standards.
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(73 days)
LIAISON Anti-HAV Assay
The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presponse to HAV in vaccine recipients.
The assay is not intended for screening blood or solid or soft tissue donors.
The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. The assay uses magnetic particles (solid phase) coated with IqG antibodies to HAV (mouse monoclonal), and a mouse monoclonal anti-HAV antibody conjugate linked to an isoluminol derivative (isoluminol-antibody conjuqate). The first incubation step consists of adding the HAV antigen to calibrators, samples or controls, during which anti-HAV present in calibrators, samples or controls binds to a fixed and limited amount of HAV. thus forming an HAV-anti-HAV immune complex. After this step the second incubation follows and it involves addition of magnetic microparticles and conjugate into the cuvette, during which the antibody conjugate and the solid-phase antibody compete with anti-HAV present in the specimen for HAV. This allows the conjugate to bind to the solid phase and to form a sandwich. If all HAV added is sequestered in an HAV-anti-HAV immune complex during the first incubation, no sandwich is formed during the second incubation. After the second incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely indicative of anti-HAV present in calibrators, samples or controls.
Here's an analysis of the provided text regarding the DiaSorin Inc. LIAISON® Anti-HAV device, outlining acceptance criteria and study details:
Acceptance Criteria and Device Performance
The provided document describes two main performance studies: a Method Comparison study and a Reproducibility study. The "acceptance criteria" are implied by the reported agreement percentages and coefficient of variation (%CV) values, which are generally expected to be high for agreement and low for variation in diagnostic assays.
Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | ||
| Negative Agreement | High agreement (e.g., >85-90%) with predicate. | 97.4% (38/39) 95% Cl: 86.8% to 99.5% |
| Positive Agreement | High agreement (e.g., >85-90%) with predicate. | 96.7% (58/60) 95% Cl: 88.6% to 99.1% |
| Overall Agreement | High agreement (e.g., >90%) with predicate. | 97.0% (96/99) 95% Cl: 91.5% to 99.0% |
| Reproducibility | ||
| Repeatability (within Day) | Low %CV (e.g., |
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(140 days)
LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparinized plasma samples using the automated LIAISON® Analyzer. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV Infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients.
This assay is not intended for screening blood or solid or soft tissue donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations.
The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.
The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. The assay uses magnetic particles (solid phase) coated with IgG antibodies to HAV (mouse monoclonal), and a mouse monoclonal anti- HAV antibody conjugate linked to an isoluminol derivative (isoluminol-antibody conjugate).
The first incubation step consists of adding the HAV antigen to calibrators, samples or controls, during which anti-HAV present in calibrators, samples or controls binds to a fixed and limited amount of HAV, thus forming an HAV-anti-HAV immune complex.
After this step the second incubation follows and it involves addition of magnetic microparticles and conjugate into the reaction module, during which the antibody conjugate and the solid-phase antibody compete with anti-HAV present in the specimen for HAV. This allows the conjugate to bind to the solid phase and to form a sandwich. If all HAV added is sequestered in an HAV-anti-HAV immune complex during the first incubation, no sandwich is formed during the second incubation. After the second incubation, the unbound material is removed with a wash cycle.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminolantibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely indicative of anti-HAV present in calibrators, samples or controls.
The provided text describes the performance data for the DiaSorin LIAISON® Anti-HAV assay. However, it does not explicitly state specific acceptance criteria (e.g., "Positive agreement must be >= 95%"). Instead, it reports the observed performance (percent agreement and confidence intervals) which implies these results were deemed acceptable by the regulatory body for 510(k) clearance based on substantial equivalence to a predicate device.
Therefore, the table below will present the reported device performance, and the description will elaborate on the various studies conducted to demonstrate this performance.
Acceptance Criteria and Study Details for DiaSorin LIAISON® Anti-HAV Assay
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria (e.g., "The positive agreement must be at least X%") are not stated in the provided document, the table will reflect the reported performance that was found to be sufficient for substantial equivalence. The document presents "Percent Agreement" values along with their 95% Confidence Intervals as the primary performance metrics. The underlying acceptance for these values is implicit through the 510(k) clearance process, which confirms the device is safe and effective as a predicate device.
| Performance Metric Category | Reported Device Performance (Percent Agreement) | 95% Confidence Interval |
|---|---|---|
| Prospective Population | ||
| At Risk / HAV Testing (Positive) | 96.6% | 93.5% - 98.0% |
| At Risk / HAV Testing (Negative) | 99.0% | 97.9% - 99.6% |
| Pediatric Population (Positive) | 78.6% | 49.2% - 95.3% |
| Pediatric Population (Negative) | 96.8% | 92.0% - 99.1% |
| Retrospective Population | ||
| Current/Previous HAV Infection | 100.0% | 98.0% - 100% |
| Pediatric Current/Previous HAV Inf. | 100.0% | 98.0% - 100% |
Note: The low positive agreement for the Pediatric Population (78.6%) with a wide confidence interval (49.2 – 95.3%) indicates a smaller number of positive samples in that specific cohort, but was still accepted for clearance.
2. Sample Sizes and Data Provenance
- Prospective Studies:
- HAV Testing and At Risk Populations: 739 samples.
- 500 excess serum samples from individuals in the Northeastern U.S. sent for HAV testing.
- 239 samples from individuals at risk for viral hepatitis (homosexual males, healthcare workers, commercial sex workers, drug users, prison inmates, dialysis patients, hemophiliacs).
- Pediatric Population: 108 samples from children in the United States.
- Vaccine Study: 73 individuals (9 TWINRIX sets, 32 HAVRIX sets, 32 VAQTA sets of pre- and post-vaccine samples).
- HAV Testing and At Risk Populations: 739 samples.
- Retrospective Studies:
- Current/Previous HAV Infection (Adults): 109 samples from adults in Eastern U.S. and Egypt.
- Current HAV Infection (Pediatric): 42 samples from pediatric patients in Egypt.
- Expected Values (Prevalence Study): 802 apparently healthy adults (301 from Western U.S., 501 from Eastern U.S.).
Data Provenance: The data is a mix of prospective and retrospective collections. Geographically, samples were from the Northeastern U.S., other unspecified regions of the U.S. (for at-risk groups and pediatric prospective), Eastern U.S., Western U.S., and Egypt.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test sets. Instead, the "Comparator ELISA" assay is consistently referred to as the reference method for determining the true positive, negative, or equivocal status of samples. This implies that the accepted clinical standard for Hepatitis A testing at the time (the predicate ELISA assay) served as the ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving multiple experts. The comparator ELISA assay results were the reference. For samples that yielded "Equivocal" or "Borderline" results by the comparator ELISA, these were sometimes retested per the Instructions for Use of the comparator method. Samples that remained equivocal or borderline after retesting were handled as distinct categories in the comparison tables.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is an in vitro diagnostic (IVD) assay designed to be read by automated equipment (LIAISON® Analyzer) and interpreted by laboratory professionals, not primarily by human "readers" interpreting images or complex data in the same way an AI for medical imaging would. The performance is compared to a predicate assay, not human interpretation.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was done. The entire performance evaluation section ("Performance Data") describes the performance of the LIAISON® Anti-HAV assay as a standalone algorithm/device, comparing its results directly against those of a predicate ELISA assay on various sample populations. There is no human-in-the-loop component described for these performance evaluations.
7. Type of Ground Truth Used
The ground truth was established by a comparator ELISA assay, which is referred to throughout the document as the reference method. Specifically, the predicate device, DiaSorin Inc. ETI-AB-HAVK Plus assay (PMA #P890019/S05), served as the standard for comparison.
8. Sample Size for the Training Set
The document does not specify a separate "training set" size. For in vitro diagnostic (IVD) assays, the development process typically involves internal method validation and optimization by the manufacturer, rather than a distinct "training set" in the machine learning sense. The samples described in the "Performance Data" section are effectively the "test set" or clinical validation set used to demonstrate performance for regulatory submission.
9. How Ground Truth for the Training Set Was Established
As no explicit training set is mentioned in the context of machine learning, this question is not directly applicable. For the overall assay development and validation, the ground truth was established by comparison to existing, clinically accepted methods, presumably the predicate ELISA assay during earlier stages of development and optimization.
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