(108 days)
The LIAISON® HAV IgM assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum and sodium heparin plasma using the LIAISON® Analyzer. Assay results, in conjunction with other serological and clinical information, may be used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis as an aid in the laboratory diagnosis of acute or recent HAV infection. 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 HAV IgM (negative and reactive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® HAV IgM assay.
The method for qualitative determination of HAV IgM is an antibody capture chemiluminescence immunoassay (CLIA). IgG to human IgM (mouse monoclonal) is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to HAV is linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, IgM antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with HAV antigen just added and the immune complex thus formed reacts with IgM already bound to the solid phase. After each 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 indicative of anti-HAV IgM present in calibrators, samples or controls.
Here's a summary of the acceptance criteria and study details for the LIAISON® HAV IgM device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section. However, the "Conclusion" section summarizes the achieved performance which implies these were the target performance metrics for demonstrating equivalence. The "Comparative Clinical Trials" section details the studies that generated these performance metrics.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance | Study Type |
|---|---|---|---|
| Overall Agreement (Prospective: "At Risk" and "HAV Testing" populations) | High agreement with predicate ELISA | 99.9% (95% CI = 99.1 - 100%) | Comparative Clinical Trial (Prospective) |
| Overall Agreement (Pediatric Population) | High agreement with predicate ELISA | 100.0% (95% CI = 97.3 - 100%) | Comparative Clinical Trial (Prospective) |
| Reactive Percent Agreement (Retrospective: Acute HAV Infection) | High agreement with predicate ELISA | 96.7% (95% CI = 92.7 - 98.9%) | Comparative Clinical Trial (Retrospective) |
| Analytical Sensitivity (Seroconversion Panels) | Equivalent to or more sensitive than predicate assay | Equivalent to or more sensitive than comparator assay | Analytical Sensitivity (Seroconversion Panels) |
| Reproducibility (Overall %CV) | Low coefficient of variation (typical for diagnostic assays) | Ranged from 10.7% to 54.2% across various samples (lower for reactive, higher for negative/equivocal) | Reproducibility/Precision Study |
| Cross-Reactivity | No false positives for tested interfering substances | 0 reactive results out of 195 samples for various organisms/conditions | Cross-Reactivity Study |
| Interference from other substances (Hemoglobin, Lipemia, Bilirubin, Albumin, Gamma Globulin) | No impact on results at specified concentrations | No impact at: Hemoglobin (1000 mg/dL), Lipemia (3000 mg/dL), Icterus (20 mg/dL), Albumin (5 g/dL), y-Globulin (4 g/dL) | Potentially Interfering Substances Study |
2. Sample Size Used for the Test Set and Data Provenance:
- Prospective Studies:
- Individuals sent to the lab for HAV testing: 500 samples (from Northeastern US).
- Individuals At Risk for Viral Hepatitis: 239 individuals (from various locations based on at-risk groups like homosexual males, healthcare workers, commercial sex workers, drug users, prison inmates, dialysis patients, hemophiliacs).
- Pediatric Population: 108 prospectively collected samples (from children in the United States).
- Retrospective Study:
- Acute HAV Infection: 123 samples (including 42 acute pediatric samples from Egypt).
- Seroconversion Panels: 5 commercially available panels.
- Reproducibility Study: A coded panel of 12 frozen "engineered" serum samples.
- Cross-Reactivity Study: 195 samples from individuals with various organisms/conditions.
- Potentially Interfering Substances Study: Not explicitly stated, implied to be laboratory-prepared samples.
- Data Provenance: Mixed.
- Prospective: Northeastern US (for general HAV testing population), United States (for pediatric), and various unspecified locations (for at-risk groups).
- Retrospective: Egypt (for some pediatric acute HAV cases), and generally from individuals with acute HAV infection (locations not fully specified beyond that).
- Seroconversion panels: Commercially available.
- Reproducibility: Samples prepared by DiaSorin S.p.A.
- Cross-Reactivity: No specific country of origin mentioned for these diverse samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document doesn't mention the use of experts to establish ground truth for the test set. Instead, the LIAISON® HAV IgM assay performance was compared against a "Comparator ELISA," which is an FDA-approved method (DiaSorin Inc. ETI-HA-IGMK Plus Kit). This indicates that the ground truth was established by the results of this predicate device, implying its established validity.
4. Adjudication Method for the Test Set:
No adjudication method is described. The comparison is directly between the LIAISON® HAV IgM assay and the Comparator ELISA.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No MRMC study was mentioned. This device is an in vitro diagnostic (IVD) assay, not typically subject to MRMC studies designed for imaging or clinical interpretation where human readers are involved. It's an automated assay reporting a result without human interpretation of raw data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are standalone performance studies for the LIAISON® HAV IgM assay. The device measures IgM antibodies in a sample and provides a qualitative result (Reactive, Equivocal, Negative) without a human interpreting the raw chemiluminescence signal to assign the final diagnosis. The intended use clearly states it's for in vitro diagnostic use, producing results in conjunction with other serological and clinical information.
7. The Type of Ground Truth Used:
The primary ground truth used for the comparative clinical trials was the result from an FDA-approved comparator ELISA assay (DiaSorin Inc. ETI-HA-IGMK Plus Kit). For the acute HAV infection cases, the samples were from individuals "who had an (Acute) HAV infection," implying a clinical diagnosis potentially confirmed by other means, but the direct comparison was still against the predicate ELISA. For seroconversion panels, these are well-characterized commercial panels with known seroconversion profiles.
8. The Sample Size for the Training Set:
The document does not explicitly mention a "training set" or "validation set" in the context of machine learning model development. This is a traditional IVD assay, not an AI/ML diagnostic. The clinical trials described are for performance evaluation against a predicate.
9. How the Ground Truth for the Training Set Was Established:
As this is not an AI/ML diagnostic, there is no explicit "training set" or associated ground truth establishment process for machine learning. The device's performance was evaluated against an established FDA-approved method (predicate ELISA) and known seroconversion panels.
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5.0 510(k) SUMMARY
NOV - 3 2008
Carol A. DePouw Regulatory Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285
Phone (651) 351-5850 Fax (651) 351-5669 Email: carol.depouw@diasorin.com
NAME OF DEVICE:
SUBMITTED BY:
Trade Name:
| Common Names/Descriptions: | He |
|---|---|
| ---------------------------- | ---- |
Classification Names:
Product Code:
PREDICATE DEVICES
LIAISON® HAV IgM
patitis A Virus (HAV Serological Reagents)
Hepatitis A Test (Antibody and IgM Antibody)
LOL
DiaSorin Inc. ETI-HA-IGMK Plus Kit (PMA #P890014/S002)
DEVICE DESCRIPTION:
INTENDED USE: The LIAISON® HAV IgM assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum and sodium heparin plasma using the LIAISON® Analyzer. Assay results, in conjunction with other serological and clinical information, may be used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis as an aid in the laboratory diagnosis of acute or recent HAV infection.
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 HAV IgM (negative and Reactive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® HAV IgM assay.
KIT DESCRIPTION: The method for qualitative determination of HAV IgM is an antibody capture chemiluminescence immunoassay (CLIA). lgG to human IgM (mouse monoclonal) is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to HAV is linked to an isoluminol derivative
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(isoluminol-antibody conjugate). During the first incubation, IgM antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with HAV antigen just added and the immune complex thus formed reacts with IgM already bound to the solid phase. After each 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 indicative of anti-HAV IgM present in calibrators, samples or controls.
PERFORMANCE DATA:
COMPARATIVE CLINICAL TRIALS: Prospective and Retrospective studies were performed to evaluate the performance of the LIAISON® HAV IgM assay among individuals who were sent to the lab for Hepatitis A testing and those at high risk for viral hepatitis.
The prospective study consisted of 500 samples from Individuals who were sent to the lab for HAV testing, 239 individuals at risk for viral hepatitis, and 108 Pediatric patients. The retrospective study consisted of 123 samples from individuals with an Acute Hepatitis A infection including 42 pediatric patients with an acute infection.
Prospective
Individuals sent to the Lab for HAV testing
A total of 500 samples collected from the Northeastern US were included in this study. Of the samples from individuals sent to the lab for HAV testing, 59.8% were female (n=299) ranging in age from 20 - 101 yrs. and 40.2% were male (n=201) ranging in age from 17 to 89.
Individuals At Risk for Viral Hepatitis
A total of 239 individuals at risk for viral hepatitis due to lifestyle, behavior or occupation were included in this study. The 239 individuals were from the following at risk groups: homosexual males (n=38), healthcare workers (n=10), Commercial sex workers (n=34), drug users (n=77), prison inmates (n=49), dialysis patients (n=25) and hemophiliacs (n=6). Of the at risk individuals, 29.7% were females (n=71), ranging in age from 17 to 79, and 43.1% were males (n=103) ranging in age from 16 to 79. The age and gender were unknown for the remaining 27.2% (n=65).
The data for the combined populations are shown in Table 1.
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| LIAISON®HAV IgM | Comparator ELISA | Total | ||
|---|---|---|---|---|
| Reactive | Equivocal | Negative | ||
| Reactive | 0 | 0 | 1 | 1 |
| Equivocal | 0 | 0 | 0 | 0 |
| Negative | 0 | 0 | 738 | 738 |
| Total | 0 | 0 | 739 | 739 |
| Table 1: HAV testing population and At risk | |||
|---|---|---|---|
| population comparison of LIAISON® HAV IgM and the Comparator ELISA |
| Negative Percent Agreement | Exact 95% Confidence Interval | |
|---|---|---|
| Negative | 738/739 99.9% | 99.4 – 100% |
Pediatric Population
One hundred eight (108) prospectively collected pediatric samples were tested. The 108 pediatric samples were collected from children in the United States. Of these 108 samples 57.4% were female (n=62) and 42.6% were male (n=46), ranging in age from 2 to 17.
The results are presented in the Table 2.
Table 2: Pediatric Population Comparison of LIAISON® HAV IgM and Comparator ELISA
| LIAISON®HAV IgM | Comparator ELISA | Total | ||
|---|---|---|---|---|
| Reactive | Equivocal | Negative | ||
| Reactive | 0 | 0 | 0 | 0 |
| Equivocal | 0 | 0 | 0 | 0 |
| Negative | 0 | 0 | 108 | 108 |
| Total | 0 | 0 | 108 | 108 |
| Negative Percent Agreement | Exact 95% Confidence Interval | ||
|---|---|---|---|
| Negative | 108/108 | adversions of analy of the first from Public Print Prints of Prints of Prints of Property of Children Comments of Children Comments of Children Comments of Children100% | Acres and any of the first of the first and the comments97.3 — 100% |
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Acute HAV Infection;
A retrospective population was tested which consisted of 123 samples from individuals who had an (Acute) HAV infection. Of these 123 samples, 42 were acute pediatrics collected from children in Eqypt. There were 32.5% females (n=40) ranging in age from 4 to 51, 51.2% males (n=63) ranging in age from 4 to 51. For 15.5% of the samples gender and age were unknown. One sample (0.8%) age 18, but gender was unknown. The results are presented in the Table 3.
| LIAISON®HAV IgM | Comparator ELISA | Total | ||
|---|---|---|---|---|
| Reactive | Borderline | Negative | ||
| Reactive | 119 | 4 | 0 | 123 |
| Equivocal | 0 | 0 | 0 | 0 |
| Negative | 0 | 0 | 0 | 0 |
| Total | 119 | 4 | 0 | 123 |
Table 3: Comparison of LIAISON® HAV IgM and the Comparator ELISA
| and and the will be will be will be the world and the world and the world be and the comments of the count | Reactive Percent Agreement | Exact 95% Confidence Interval | |
|---|---|---|---|
| Reactive | 119/123 | 96.7% | 92.7 - 98.9% |
Conclusion: The LIAISON® HAV IgM assay showed equivalent performance to the FDA approved comparison method. The LIAISON® HAV IgM demonstrated overall agreement with the Comparator ELISA as follows:
Prospective Population "At Risk" and "HAV Testing" - 99.9% (95% Cl = 99.1 - 100%) Pediatric Population - 100.0% (95% Cl = 97.3 - 100%) Retrospective Population Acute HAV Infection - 96.7% (95% Cl = 92.7 - 98.9%)
The results demonstrate that the LIAISON® HAV IgM assay can be used with the LIAISON® Analyzer for the qualitative detection of IgM antibodies to hepatitis A virus.
EXPECTED VALUES :
Prevalence
The expected prevalence results of the LIAISON® HAV IgM assay were determined in 802 apparently healthy adults from the Western (historically high prevalence) and the Eastern (historically lower prevalence) regions of the U.S. Three hundred one (301) samples were from the Western U.S. and 501 were samples from the Eastern U.S.
Of the Western U.S. individuals 53.8% were females (n=162) ranging in age from 9 to 87 and 46.2% were males (n=139) ranging in age from 16 to 76. The majority of the individuals were Caucasian (60.8%), with other ethnic groups represented as follows: Hispanic (17.6%), African Americans (15.3%), Asian (6.0%) and Middle Eastern (0.3%). In the study group from the Western region, none of the individuals were found to be reactive for HAV IgM antibodies.
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Of the Eastern U.S. individuals 46.5% were females (n=233) ranging in age from 17 to 83, and 53.5% were males (n=268) ranging in age from 17 to 82. The majority of the individuals were Caucasian (69.9%), with other ethnic groups represented as follows: Hispanic (14.0%), African American (12.1%) and Asian (4.0%).
In the study group from the Eastern region none of the individuals were found to be reactive for HAV IqM antibodies.
The expected results for the Western and Eastern regions of the U.S. are presented in the tables below.
| N | Negative | Equivocal | Reactive | ReactivePrevalence | |
|---|---|---|---|---|---|
| Total | 301 | 301 | 0 | 0 | NA |
| Gender | |||||
| Female | 162 | 162 | 0 | 0 | NA |
| Male | 139 | 139 | 0 | 0 | NA |
| Age range (years) | N | (-) | (E) | (+) | |
| ≤18 | 12 | 12 | 0 | 0 | NA |
| <10 | 1 | 1 | 0 | 0 | NA |
| 10 - 19 | 15 | 15 | 0 | 0 | NA |
| 20 - 29 | 81 | 81 | 0 | 0 | NA |
| 30 - 39 | 68 | 68 | 0 | 0 | NA |
| 40 - 49 | 52 | 52 | 0 | 0 | NA |
| 50 - 59 | 48 | 48 | 0 | 0 | NA |
| 60 - 69 | 31 | 31 | 0 | 0 | NA |
| ≥ 70 | 5 | 5 | 0 | 0 | NA |
Expected results for the LIAISON® HAV IgM assay from the Western U.S. (n=301)
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| N | Negative | Equivocal | Reactive | ReactivePrevalence | |
|---|---|---|---|---|---|
| Total | 501 | 501 | 0 | 0 | NA |
| Gender | |||||
| Female | 233 | 233 | 1 | 44 | NA |
| Male | 268 | 268 | 0 | 56 | NA |
| Age range (years) | N | (-) | (E) | (+) | |
| ≤18 | 46 | ||||
| <10 | 0 | ||||
| 10 - 19 | 49 | 49 | 0 | 0 | NA |
| 20 - 29 | 39 | 39 | 0 | 0 | NA |
| 30 - 39 | 78 | 78 | 0 | 0 | NA |
| 40 - 49 | 107 | 107 | 0 | 0 | NA |
| 50 - 59 | 142 | 142 | 0 | 0 | NA |
| 60 - 69 | 52 | 52 | 0 | 0 | NA |
| ≥ 70 | 34 | 34 | 0 | 0 | NA |
Expected results for the LIAISON® HAV IgM assay from the Eastern U.S. (n=501)
SEROCONVERSION PANEL:
Analytical Sensitivity as Seroconversion Panel Performance
Five commercially available HAV seroconversion panels were tested using LIAISON® HAV IgM and the FDA approved comparator assay to determine the sensitivity of the assay. The results are summarized in the following table:
| DiaSorin LIAISON HAV IgM* | Comparator Assay* | |||||
|---|---|---|---|---|---|---|
| Panel ID | Post Bleed Dayof EarliestReactive Result | Post BleedDay of LastReactiveResult | Post Bleed Dayof EarliestReactive Result | Post Bleed Dayof Last ReactiveResult | Difference inDays from LastReactive Result | |
| PHT901seroconversion | 12 | 17 | 12 | 17 | 0 | |
| PHT902seroconversion | 16 | 21 | 16 | 21 | 0 | |
| RP004seroconversion | 6 | 62 | 6 | 62 | 0 | |
| RP013seroconversion | 8 | 189 | 8 | 189 | 0 | |
| HAV01seroconversion | 0 | 77 | 0 | 91 | 14 |
- Only reactive results were used; equivocal results were not used to determine a reactive result.
The sensitivity of the LIAISON® HAV IgM was equivalent to or more sensitive than the comparator assay in the five seroconversion panels tested.
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REPRODUCIBILITY: A 5 day reproducibility/precision study was conducted at three external laboratories. The CLSI document EP15-A2 was consulted in the preparation of the testing protocol.
A coded panel comprised of 12 frozen "engineered" serum samples was prepared by DiaSorin S.p.A. and provided to the sites. The coded panel samples were prepared by spiking reactive samples into negative sample to achieve high negative, low reactive and high reactive results. The two negative panel samples were not spiked. The LIAISON® Control HAV IgM set were also included in the 5 day study.
Results
The 5 day Index results are summarized in Table 4 (combined sites). The mean Index value, standard deviation, and coefficient of variation (%CV) of the results were computed for each of the tested specimens for each of the sites.
| sample | N | mean | withinrun | betweenruns | total(by site) | betweensites | Overall | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ID# | Index | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| NC | 60 | 0.15 | 0.02 | 14.2 | 0.08 | 15.6 | 0.02 | 19.6 | 0.14 | 63.6 | 0.08 | 54.2 |
| PC | 60 | 2.17 | 0.11 | 5.2 | 0.21 | 4.7 | 0.10 | 6.5 | 0.10 | 10.3 | 0.23 | 10.7 |
| HAMu-el | 60 | 0.73 | 0.03 | 4.4 | 0.17 | 9.1 | 0.07 | 9.7 | 0.40 | 24.9 | 0.17 | 23.5 |
| HAMu-e2 | 60 | 0.81 | 0.05 | 6.9 | 0.18 | 9.9 | 0.08 | 11.6 | 0.59 | 23.2 | 0.18 | 22.6 |
| HAMu-n1 | 60 | 0.49 | 0.02 | 4.9 | 0.11 | 7.8 | 0.04 | 9.1 | 0.07 | 23.8 | 0.11 | 22.7 |
| HAMu-n2 | 60 | 0.42 | 0.02 | 4.4 | 0.09 | 7.0 | 0.03 | 8.0 | 0.09 | 23.3 | 0.09 | 21.2 |
| HAMu-P1 | 60 | 6.87 | 0.35 | 5.2 | 0.82 | 7.5 | 0.52 | 9.2 | 3.97 | 10.3 | 0.87 | 12.7 |
| HAMu-P2 | 60 | 4.48 | 0.30 | 6.7 | 0.75 | 9.7 | 0.44 | 11.3 | 0.10 | 15.8 | 0.78 | 17.4 |
| HAMu-P3 | 60 | 2.45 | 0.12 | 5.3 | 0.45 | 6.7 | 0.18 | 9.5 | 2.64 | 19.4 | 0.46 | 18.8 |
| HAMu-P4 | 60 | 2.17 | 0.09 | 4.1 | 0.33 | 7.9 | 0.18 | 8.4 | 0.71 | 14.6 | 0.34 | 15.5 |
| HAMu-P5 | 60 | 1.95 | 0.08 | 4.0 | 0.24 | 8.7 | 0.17 | 8.9 | 0.27 | 10.4 | 0.25 | 12.6 |
| HAMu-P6 | 60 | 1.53 | 0.06 | 4.0 | 0.27 | 7.1 | 0.11 | 7.6 | 0.07 | 18.9 | 0.27 | 17.4 |
| HAMu-P7 | 60 | 1.31 | 0.06 | 4.8 | 0.22 | 9.5 | 0.13 | 10.0 | 0.17 | 16.2 | 0.22 | 16.8 |
| HAMu-P8 | 60 | 1.24 | 0.07 | 5.6 | 0.28 | 12.6 | 0.15 | 12.8 | 0.12 | 22.4 | 0.28 | 22.5 |
Table 4: Combined Sites
CROSS-REACTIVITY:
The cross-reactivity study for the LIAISON® HAV IgM assay was designed to evaluate potential interference from other viruses that may cause symptoms similar to HAV infection (EBV, CMV, Rubella, Measles, Mumps, HBV, HCV), other organisms that may cause infectious disease (VZV, HSV, HIV, Toxoplasma gondii) and from other conditions that may result from atypical immune system activity (i.e. rheumatoid factor, RF, antinuclear autoantibodies, ANA, human anti-mouse antibodies,
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| Organism/Condition | N | ComparatorHAV IgM Assay | LIAISON®HAV IgM Reactive | LIAISON®HAV IgM Negative | LIAISON®HAV IgM Equivocal |
|---|---|---|---|---|---|
| IgG anti-Measles | 3 | Negative | 0 | 3 | 0 |
| IgG anti-Mumps | 8 | Negative | 0 | 8 | 0 |
| IgG anti-VCA | 3 | Negative | 0 | 3 | 0 |
| IgG anti-EA | 3 | Negative | 0 | 3 | 0 |
| IgG anti-CMV | 3 | Negative | 0 | 3 | 0 |
| IgG anti-Rubella | 2 | Negative | 0 | 2 | 0 |
| IgG anti-Toxoplasma | 3 | Negative | 0 | 3 | 0 |
| IgG anti-HSV-1/2 | 1 | Negative | 0 | 1 | 0 |
| IgG anti-HSV-2 | 6 | Negative | 0 | 6 | 0 |
| IgG anti-syphilis | 4 | Negative | 0 | 4 | 0 |
| Anti-VZV | 3 | Negative | 0 | 3 | 0 |
| Anti-HTLV I/II | 3 | Negative | 0 | 3 | 0 |
| Anti-HCV | 4 | Negative | 0 | 4 | 0 |
| Anti-Borrelia | 4 | Negative | 0 | 4 | 0 |
| Anti-HBs | 3 | Negative | 0 | 3 | 0 |
| Anti-HIV | 10 | Negative | 0 | 10 | 0 |
| Anti-Parvovirus B19 | 4 | Negative | 0 | 4 | 0 |
| IgM anti-HBc | 4 | Negative | 0 | 4 | 0 |
| IgM anti-Borrelia | 5 | Negative | 0 | 5 | 0 |
| IgM anti-CMV | 5 | Negative | 0 | 5 | 0 |
| IgM anti-EBV | 5 | Negative | 0 | 5 | 0 |
| IgM anti-HSV | 7 | Negative | 0 | 7 | 0 |
| IgM anti-Rubella | 6 | Negative | 0 | 6 | 0 |
| IgM anti-Toxoplasma | 5 | Negative | 0 | 5 | 0 |
| IgM anti-VZV | 6 | Negative | 0 | 6 | 0 |
| Anti-Influenza virus | 3 | Negative | 0 | 3 | 0 |
| HBsAg | 3 | Negative | 0 | 3 | 0 |
| HBeAg | 6 | Negative | 0 | 6 | 0 |
| Nucleotides | 4 | Negative | 0 | 4 | 0 |
| ENA | 4 | Negative | 0 | 4 | 0 |
| Rheumatoid Factor | 17 | Negative | 0 | 17 | 0 |
| y-globulin | 36 | Negative | 0 | 36 | 0 |
| HAMA | 12 | Negative | 0 | 12 | 0 |
| Total | 195 | 0 | 195 | 0 |
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POTENTIALLY INTERFERING SUBSTANCES:
Controlled studies were performed to determine whether the presence of hemoglobin, lipemia, bilirubin, serum albumin and gamma globulin affect assay performance. The highest concentrations which were considered not to impact results are as follows: hemolysis (at 1000 mg/dL hemoglobin), lipemia (at 3000 mg/dL triglycerides), icterus (at 20 mg/dL bilirubin), serum albumin (at 5 g/dL), y-Globulin (at 4 g/dL).
CONCLUSION:
The material submitted in this premarket notification is complete and supports a substantial equivalence decision. The labeling is sufficient and it satisfies the requirements of 21CFR 809.10
{9}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
The same to the minister the mail of the mail of the mail of the mail of the mail of the mail of the the
Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the left side of the eagle in a circular fashion.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Carol DePouw Regulatory Affairs Specialist Diasorin Inc. 1951 Northwestern Avenue P. O. Box 285 Stillwater, MN 55082-0285
NOV - 3 2008
Re: K082050
Trade/Device Name: LIAISON® HAV IgM Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A virus (HAV) serological assays Regulatory Class: Class II Product Code: LOL Dated: October 24, 2008 Received: October 27, 2008
Dear Ms. DePouw:
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 (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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
and and the first of the start of the county of the comment of the many of the may be and the may be any and
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 1egally marketed predicate device results in a classification for your device and thus, permitts your device to proceed to the market.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. , Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain (1122 general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sally attaym
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K082050
Device Name:
LIAISON® HAV IgM and LIAISON® Control HAV IqM
Indication For Use: The LIAISON® HAV IgM assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of IqM antibodies to hepatitis A virus (IgM anti-HAV) in human serum and sodium heparin plasma using the LIAISON® Analyzer. Assay results, in conjunction with other serological and clinical information, may be used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis as an aid in the laboratory diagnosis of acute or recent HAV infection.
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 HAV IgM (negative and reactive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® HAV IgM assay.
Prescription Use X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Souy attyr
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K062050
§ 866.3310 Hepatitis A virus (HAV) serological assays.
(a)
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.(b)
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.