(182 days)
P890019
Not Found
No
The device description details a standard enzyme immunoassay (EIA) process involving chemical reactions and spectrophotometric measurement. There is no mention of AI, ML, or any computational analysis beyond comparing absorbance values to a cutoff. The performance studies describe traditional statistical analysis of agreement and variability.
No
The device is an in vitro diagnostic test for the detection of Hepatitis A Virus antibodies, used as an aid in diagnosis, not for treating or preventing the disease.
Yes
The "Intended Use" section explicitly states that the kit is "intended for use in the qualitative detection of total antibodies... as an aid in the diagnosis of acute or past Hepatitis A Virus (HAV) infection." This directly indicates its diagnostic purpose.
No
The device is an in vitro enzyme immunoassay kit, which is a laboratory test that involves physical reagents and procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the MONOLISA™ Anti-HAV EIA is an "in vitro enzyme immunoassay kit intended for use in the qualitative detection of total antibodies... in human... serum or plasma". This clearly indicates that the device is used outside of the body to examine specimens from the human body.
- Device Description: The description details a laboratory-based assay procedure involving patient specimens, reagents, and spectrophotometric measurement, which is characteristic of an in vitro diagnostic test.
- Performance Studies: The document describes extensive performance studies conducted on human specimens (serum and plasma) to evaluate the device's accuracy in detecting anti-HAV antibodies. These studies are typical for IVD devices seeking regulatory approval.
N/A
Intended Use / Indications for Use
The MONOLISA™ Anti-HAV EIA is an in vitro enzyme immunoassay kit intended for use in the qualitative detection of total antibodies (anti-HAV IgG and IgM) to Hepatitis A virus (anti-HAV) in human (adult and pediatric) serum or plasma (EDTA, Heparin, Citrate, ACD. This assay is not intended for screening blood or solid or soft tissue donors.
The MONOLISA™ anti-HAV EIA is indicated for use as an aid in the diagnosis of acute or past Hepatitis A Virus (HAV) infection or as an aid in the identification of HAV-susceptible individuals for vaccination. However, any diagnosis should take into consideration the patient’s clinical history and symptoms, as well as serological data. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, and core blood or neonatal specimens.
Product codes
LOL
Device Description
The MONOLISA™ Anti-HAV EIA is an enzyme immunoassay (competitive assay format) for the detection of total antibodies to Hepatitis A virus. In the assay procedure, patient specimens, a calibrator and controls are incubated with HAV antigen in microwells that have been coated with mouse monoclonal anti-Hepatitis A antibodies to HAV present in a specimen or control will complex with the HAV antigen reagent and with antibodies coated on the microwells. Excess sample and HAV Viral antigen reagent are removed by a wash step. The conjugate (containing horseradish peroxidase-labeled mouse monoclonal antibody to HAV) is subsequently added to the microwells and incubated. The conjuqate binds to the HAV antigen bound to the microwell in the absence of antibodies to HAV from the specimen. Excess conjugate is removed by a wash step, and a TMB Chromogen / Substrate solution is added to the microwells and allowed to incubate. If a sample does not contain anti-HAV antibodies, the bound enzyme (HRP) causes the colorless tetramethylbenzidine (TMB) in the Chromogen solution to change to blue. The blue color turns yellow after the addition of a Stopping Solution. If a sample contains anti-HAV antibodies, the Chromogen / Substrate Solution in the well remains colorless during the substrate incubation, and after the addition of the Stopping Solution. The color intensity is measured spectrophotometrically. Absorbance value readings for patient specimens are compared to the Cutoff value determined by the mean of the Calibrator absorbance values.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance: A multi-center prospective and retrospective study was conducted to evaluate the clinical performance of the MONOLISA™ Anti-HAV EIA assay among individuals with signs or symptoms and those at high risk of Hepatitis infection. Specimens were collected in 3 different geographical areas: 404 specimens were collected in the US and 928 were collected in Europe (France and Italy).
- The US population consisted of 174 subjects with signs and symptoms of Hepatitis and 230 subjects from the high-risk group for Hepatitis A. The mean age was 38 for symptomatic subjects (ranging from 17 to 72 years) and 45 for high-risk subjects (ranging from 18 to 70 years).
- The European population consisted of 252 specimens collected from patients with signs and symptoms of Hepatitis, 62 specimens from a high-risk population, 345 from an asymptomatic hospitalized population, 34 from healthcare workers, and 151 from patients who had recovered HAV infection. The mean age for symptomatic patients was 53 (ranging from 1 to 105 years), and 40 for high-risk subjects (ranging from 21 to 75 years).
Vaccinated subjects: 62 pre- and post-vaccination samples from 38 individuals were tested.
- 14 individuals received TWINRIX® vaccine.
- 20 samples from 10 subjects (aged 24 to 45 years) received HAVRIX® vaccine.
- 14 purchased post-vaccination samples were from individuals vaccinated with HAVRIX® and 6 were from individuals vaccinated with VAQTA® from Merck & Co.
Results from US specimens (N=404):
- Positive percent agreement: 98.8% (237/240) with 95% CI: 96.4 - 99.7
- Negative percent agreement: 92.6% (151/163) with 95% CI: 87.5 - 96.1
Results from European specimens (N=844):
- Positive percent agreement: 99.7% (610/612) with 95% CI: 98.8 – 99.9
- Negative percent agreement: 98.7% (227/230) with 95% CI: 96.2 – 99.7
Acute HAV Infection (N=84): All 84 samples (45 adults, 39 pediatrics) were reactive.
- Positive agreement: 100% (84/84) with 95% CI: 96.5% to 100%.
Performance in pediatric subjects (N=60):
- Positive percent agreement: 100% (29/29) with 95% CI: 90.2 - 100.
- Negative percent agreement: 96.8% (30/31) with 95% CI: 83.3 - 99.9.
Study on Vaccinated Subjects:
- In pre-vaccination samples, overall agreement with comparative assay for 21/22 (95.5%) samples.
- For TWINRIX® post first dose vaccination, MONOLISA™ Anti-HAV EIA demonstrated reactivity in 9/14 (64.3%) samples vs. 10/14 (71.4%) for reference method.
- For HAVRIX® post-vaccination, MONOLISA™ Anti-HAV EIA demonstrated reactivity in 18/18 (100%) samples vs. 18/18 (100%) for reference method.
- For VAQTA® post-vaccination, MONOLISA™ Anti-HAV EIA demonstrated reactivity in 6/6 (100%) samples vs. 6/6 (100%) for reference method.
Seroconversion Panels: 6 commercially available HAV seroconversion panels were tested. The sensitivity of the MONOLISA™ Anti-HAV EIA was equivalent to or more sensitive than the comparative assay.
Cross Reactivity Study: 255 specimens from 16 groups of potential cross-reactivity were tested. 7 samples were discrepant (4 reactive on MONOLISA™ Anti-HAV EIA, nonreactive on comparative assay; 3 nonreactive on MONOLISA™ Anti-HAV EIA, reactive on comparative).
Precision Study (Within-Laboratory Precision): A 21-member panel (serum and plasma samples at 3 levels) was tested.
- Negative Control C0: Total CV (%) 8.1%
- Positive Control C1: Total CV (%) 12.3%
- Serum 1: Total CV (%) 7.7%
- Serum 2: Total CV (%) 11.0%
- Serum 3: Total CV (%) 10.3%
- Other panel members (EDTA, Sodium Citrate, Sodium Heparin, Lithium Heparin, ACD) showed total CVs ranging from 7.5% to 11.8%.
Reproducibility Study: A 6-member panel was tested in triplicate, once a day for 3 days on 3 lots at 3 clinical trial sites. Total CVs ranged from 15.5% (P1) to 18.9% (P6).
Reproducibility study on Negative and Positive Controls:
- Negative Control: Total %CV 8.7%
- Positive Control: Total %CV 10.8%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
P890019
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo consists of the text "BIO+RAD" in a bold, sans-serif font. The text is white and is set against a black, rounded rectangle.
MONOLISA™ Anti-HAV EIA 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: | K 063318 |
|---|---|
| 510(k) Summary Report Date: | April, 2007 |
| MANUFACTURER INFORMATION | |
| MANUFACTURER ADDRESS: | Bio-Rad |
| 3, Boulevard Raymond Poincaré | |
| 92430 Marnes-la-Coquette, France | |
| TELEPHONE : | 00 33 1 47 95 60 00 |
| ESTABLISHMENT REG. NUMBER : | 8023060 |
| OWNER/OPERATOR : | Bio-Rad |
| 3, Boulevard Raymond Poincaré | |
| 92430 Marnes-la-Coquette, France | |
| OWNER/ OPERATOR NUMBER : | 8023061 |
| OFFICIAL CORRESPONDENT | |
| ADDRESS : | Bio-Rad |
| 3, Boulevard Raymond Poincaré | |
| 92430 Marnes-la-Coquette, France | |
| TELEPHONE: | 00 33 1 47 95 60 00 |
| OFFICIAL CORRESPONDENT : | Mrs. Sylvie Confida |
| TELEPHONE : | |
| FAX : | 00 33 1 47 95 61 38 |
| 00 33 1 47 95 62 42 | |
| CLASSIFICATION INFORMATION |
| COMMON NAME: | Total Antibody to Hepatitis A Virus |
|---|---|
| PRODUCT TRADE NAME: | MONOLISA™ Anti-HAV EIA |
| DEVICE CLASS: | Class II LOL |
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CLASSIFICATION PANEL :
Immunology and Microbiology Devices
REGULATION NUMBER : 21 CFR 866.3310
LEGALLY MARKETED EQUIVALENT (SE) DEVICE
DiaSorin ETI-AB-HAVK PLUS PMA Number : P890019 Decision Date : 12/12/2005
DEVICE DESCRIPTION
The MONOLISA™ Anti-HAV EIA is an enzyme immunoassay (competitive assay format) for the detection of total antibodies to Hepatitis A virus. In the assay procedure, patient specimens, a calibrator and controls are incubated with HAV antigen in microwells that have been coated with mouse monoclonal anti-Hepatitis A antibodies to HAV present in a specimen or control will complex with the HAV antigen reagent and with antibodies coated on the microwells. Excess sample and HAV Viral antigen reagent are removed by a wash step. The conjugate (containing horseradish peroxidase-labeled mouse monoclonal antibody to HAV) is subsequently added to the microwells and incubated. The conjuqate binds to the HAV antigen bound to the microwell in the absence of antibodies to HAV from the specimen. Excess conjugate is removed by a wash step, and a TMB Chromogen / Substrate solution is added to the microwells and allowed to incubate. If a sample does not contain anti-HAV antibodies, the bound enzyme (HRP) causes the colorless tetramethylbenzidine (TMB) in the Chromogen solution to change to blue. The blue color turns yellow after the addition of a Stopping Solution. If a sample contains anti-HAV antibodies, the Chromogen / Substrate Solution in the well remains colorless during the substrate incubation, and after the addition of the Stopping Solution. The color intensity is measured spectrophotometrically.
Absorbance value readings for patient specimens are compared to the Cutoff value determined by the mean of the Calibrator absorbance values.
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KIT COMPONENTS
| Component | Description |
|---|---|
| R1 Microwell Strip Plates | Two (2) x 12 strips of 8 wells coated with monoclonal anti-HAV |
| antibodies. | |
| R2 Wash Solution | |
| Concentrate (30x) | One (1) 120 mL bottle, Tris-buffer containing NaCl and Tween 20. |
| C0 Negative Control | One (1) 1.5 mL vial, containing human serum, negative for total anti- |
| HAV antibodies, HBs antigen, anti-HCV antibodies and anti-HIV-1/ | |
| HIV-2 antibodies. Preservatives : Sodium azide (=90 | Female |
| Male | |
| Total |
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| MONOLISAT™ Anti-HAV EIA | ||||||||
|---|---|---|---|---|---|---|---|---|
| Gender | Reactive | Borderline | Nonreactive | |||||
| Age Range | N | % | N | % | N | % | Total | |
| =90 | Female | 0 | N/A | 0 | N/A | 1 | 100.0% | 1 |
| Male | 0 | N/A | 0 | N/A | 0 | N/A | 0 | |
| Unknown | Female | 0 | N/A | 0 | N/A | 1 | 100.0% | 1 |
| Total | 92 | 37.6% | 1 | 0.4% | 152 | 62.0% | 245 |
Table 6: Expected Results for MONOLISA™ Anti-HAV EIA in subjects from the Western US (N= 245)
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| MONOLISAT™ Anti-HAV EIA | ||||||||
|---|---|---|---|---|---|---|---|---|
| Age Range | Gender | Reactive | Borderline | Nonreactive | Total | |||
| N | % | N | % | N | % | |||
| 80 | Female | 0 | N/A | 0 | N/A | 0 | N/A | 0 |
| Male | 0 | N/A | 0 | N/A | 0 | N/A | 0 | |
| Total | 28 | 45.2% | 0 | N/A | 34 | 54.8% | 62 |
.
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PERFORMANCE CHARACTERISTICS
Clinical performance
A multi-center prospective and retrospective study was conducted to evaluate the clinical performance of the MONOLISA™ Anti-HAV EIA assay among individuals with signs or symptoms and those at high risk of Hepatitis infection. Specimens were collected in 3 different geographical areas: 404 specimens were collected in the US and 928 were collected in Europe (France and Italy).
The US population consisted of 174 subjects with signs and symptoms of Hepatitis.
Of these, 60% were male and 40% were female, and they ranged in age from 17 to 72 years (mean age of 38). The group was Caucasian (13.2%), Black or African American (4.6%), Hispanic or Latino (2.9%), and Asian (41.9%), with 1.1% represented by multiple ethnic groups. The remaining 36.8% were unknown. Among these 174 subjects, 23 (13.2%) were pediatric samples.
The 230 subjects from the high-risk group for Hepatitis A include intravenous drug users (N= 55), homosexual males (N=15), sex workers (N=39), prison history (N= 92), high-risk sex partners (N=25), and high-risk occupation/health care workers (N=4). Many had more than 1 high-risk behavior or risk factor. The group was Caucasian (7.4%), Black or African American (74.3%), Hispanic or Latino (15.2%), Asian (0.4%), Native Hawaiian or other Pacific Islander (0.4%), and American Indian or Alaska native (0.9%), with the remaining (1.3%) represented by multiple ethnic groups. Of these, 81% were male and 19% were female, and they ranged in age from 18 to 70 years (mean age of 45). Among these 230 subjects, 2 (0,9%) were pediatric samples.
The European population consisted of 252 specimens collected from patients with signs and symptoms of Hepatitis. Of these, 51% were male and 49% were female, and they ranged in age from 1 to 105 years (mean age of 53).
Sixty-two (62) specimens were collected from a population at high risk for hepatitis composed of intravenous drug users (30), subjects who had clotting factor disorders (7) and MSM patients (25). The group was 87% male and 13% female, and ranged in age from 21 to 75 years (mean age of 40).
Three hundred and forty five (345) specimens were from an asymptomatic hospitalized population. Of these, 51% were male and 49% were female, and they ranged in age from 18 to 87 years (mean age of 59).
Thirfty four (34) specimens were from healthcare workers (for HAV pre-vaccination screening). One hundred and fifty one (151) patients had recovered HAV infection.
Among these 844 european samples, 35 (4.1%) were from pediatric subjects.
Vaccinated subjects:
Sixty-two (62) pre- and post-vaccination samples from 38 individuals were tested. Fourteen (14) individuals were enrolled in a vaccination program. They received the TWINRIX® vaccine, a combined Hepatitis A and Hepatitis B vaccine from GlaxoSmithKline. A pre-vaccination sample was collected the day of the first vaccination dose. A second sample was collected before the second vaccination dose was injected (one month after the first dose). A third dose of vaccine was scheduled 6 months after the first injection. The sample after the third vaccination dose was not available.
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Twenty (20) samples were collected from 10 subjects, aged 24 to 45 years, who had received the HAVRIX® vaccine. These subjects received HAVRIX® 1440, an inactivated Hepatitis A vaccine from GlaxoSmithKline, in a two-dose schedule (at 0 and 6 to 12 months). For each subject, a preand a post-vaccination specimen was obtained. All post-vaccination samples were obtained 4 weeks after vaccination.
Fourteen (14) purchased post-vaccination samples were from individuals vaccinated with HAVRIX® and 6 were from individuals vaccinated with VAQTA® from Merck &Co.
Percent Agreement
The results obtained with MONOLISA™ Anti-HAV EIA were compared with the results obtained using the comparative assay.
The positive and negative percent agreements and the 95% exact confidence between MONOLISA™ Anti-HAV EIA and the comparative assay were calculated.
To determine the percent agreement on borderline results the following criteria were used:
-
Specimens that were borderline with the comparative assay and reactive with MONOLISA™ Anti-HAV EIA were considered as false positives for MONOLISA™ Anti-HAV EIA assay.
-
Specimens that were borderline with the comparative assay and nonreactive with MONOLISA™ Anti-HAV EIA were considered as false negatives for MONOLISA™ Anti-HAV EIA.
The results obtained with the US specimens and with the European specimens are presented in the following tables.
| Table 10: MONOLISA™ Anti-HAV EIA versus the comparative assay Results in the US | |||
|---|---|---|---|
| Population (N=404) | |||
| would and the country of the contract and the contrôleant with and |
| Subject category | Comparative assay:
Positive
MONOLISA™ Anti-
HAV EIA | | | Comparative assay:
Borderline
MONOLISA™ Anti-HAV
EIA | | | Comparative assay:
Negative
MONOLISA™ Anti-
HAV EIA | | | Total |
|------------------------------------------|--------------------------------------------------------------|-----|----|---------------------------------------------------------------|-----|----|--------------------------------------------------------------|-----|-----|-------|
| | R | BRD | NR | R | BRD | NR | R | BRD | NR | |
| Subjects with signs
and symptoms | 123 | 0 | 2 | 1 | 0 | 0 | 1 | 3 | 44 | 174 |
| Subjects with high
risk for Hepatitis | 114 | 0 | 0 | 2 | 1 | 1 | 4 | 1 | 107 | 230 |
| Total | 237 | 0 | 2 | 3b | 1d | 1c | 5 | 4a | 151 | 404 |
| | Positive percent
agreement | 95% Exact
Confidence interval | Negative percent
agreement | 95% Exact
Confidence interval |
|-------|-------------------------------|----------------------------------|-------------------------------|----------------------------------|
| Total | 98,8%
(237/240) | 96.4 - 99.7 | 92.6%
(151/163) | 87.5 - 96.1 |
R : Reactive, NR : Nonreactive, BRD : Borderline
8 : the Borderline results with MONOLISA™ Anti-HAV EIA were considered as false positives.
b: the specimens that were Borderline with the comparative assay and reactive with MONOLISA'™ Anti-HAV EIA were considered as false positives with MONOLISA™ Anti-HAV EIA.
4: the results that were borderline with both the MONOLISA™ Anti-HAV EIA and with the comparative assay were not included in the negative agreement or the positive agreement calculations.
ci the specimens that were Borderline with the comparative with MONOLISA™ Anti-HAV EIA were considered as false negative with MONOLISA™ Anti-HAV EIA.
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| Table 11: Comparison of Results for MONOLISA™ Anti-HAV EIA versus the | |||||
|---|---|---|---|---|---|
| comparative assay in the European Population (N= 844) |
| Subject
category | Comparative assay:
Positive
MONOLISA™ Anti-
HAV EIA | | | Comparative assay:
Borderline
MONOLISA™ Anti-
HAV EIA | | | Comparative assay:
Negative
MONOLISA™ Anti-
HAV EIA | | | Total |
|------------------------------------------------|--------------------------------------------------------------|-----|----|----------------------------------------------------------------|-----|----|--------------------------------------------------------------|-----|-----|-------|
| | R | BRD | NR | R | BRD | NR | R | BRD | NR | |
| General
hospitalized
population | 236 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 108 | 345 |
| Sign /
Symptoms of
Hepatitis | 190 | 0 | 0 | 0 | 2 | 1 | 1 | 1 | 57 | 252 |
| Subjects
with high
risk for
Hepatitis | 28 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 34 | 62 |
| Healthcare
workers | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 28 | 34 |
| Infected/
recovered
HAV | 150 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 151 |
| Total | 610 | 0 | 1 | 1b | 2d | 1c | 1 | 1a | 227 | 844 |
| | Positive percent
agreement | 95% Exact
Confidence interval | Negative percent
agreement | 95% Exact
Confidence interval |
|-------|-------------------------------|----------------------------------|-------------------------------|----------------------------------|
| Total | 99.7%
(610/612) | 98.8 – 99.9 | 98.7%
(227/230) | 96.2 – 99.7 |
R : Reactive, NR : Nonreactive, BRD : Borderline
a : the Borderline result with MONOLISA™ Anti-HAV EIA was considered as false positive
b the specimen that was Borderline with the comparative assay and reactive with MONOLISA™ Anti-HAV EIA was considered as false positive with MONOLISA™ Anti-HAV EIA.
^ the specimen that was Borderline with the comparative assay and nonreactive with MONOLISA™ Anti-HAV EIA was considered as false negative with MONOLISA™ Anti-HAV EIA.
d :the 2 borderline results with both MONOLISA™ Anti-HAV EIA and with the comparative assay were not included in the calculation of the negative agreement or the positive agreement.
Acute HAV Infection:
Among the retrospective samples, 84 were from subjects with a medical history and laboratory results indicative of acute Hepatitis A. The subjects included 56% male, 37% female; the gender was not available for 7%. The mean age was 21, and subjects ranged from 1 to 55 years. Among them 39 were pediatric subjects.
The results are presented in the following table:
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Table 12: Comparison of Results for MONOLISA™ Anti-HAV EIA versus the comparative assay on Acute HAV infection in the adult and pediatric European Population (N= 84) :
| | Comparative assay:
Positive
MONOLISA™ Anti-HAV EIA | | | Comparative assay:
Borderline
MONOLISA™ Anti-HAV EIA | | | Comparative assay:
Negative
MONOLISA™ Anti-HAV EIA | | | Total |
|------------|----------------------------------------------------------|-----|----|------------------------------------------------------------|-----|----|----------------------------------------------------------|-----|----|-------|
| | R | BRD | NR | R | BRD | NR | R | BRD | NR | |
| Adults | 45 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 45 |
| Pediatrics | 39 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 39 |
| Total | 84 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 84 |
R: Reactive, NR: Nonreactive, BRD : Borderline
The positive agreement was 100% (84/84) with a 95% exact confidence interval of 96.5% to 100%.
Performance of MONOLISA™ Anti-HAV EIA in pediatric subjects:
Sixty (60) pediatric samples were tested during the US and European clinical studies in addition to the 39 pediatric samples from acute HAV infection.
Among the US population, 23 had signs and symptoms of hepatitis and 2 were from the high risk group. In the European population, 3 belonged to the general hospitalized population, 22 had signs and symptoms of hepatitis, 2 were from the high risk group, 3 were healthcare workers, 5 had recovered from Hepatitis A infection. The results from these pediatric samples are summarized in the following table.
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| Table 13 : Comparison of Results for MONOLISA™ Anti-HAV EIA versus the | |||||
|---|---|---|---|---|---|
| comparative assay in the Pediatric European and US Population (N= 60) |
| Subject
category | Comparative assay:
Positive | | | Comparative assay:
Borderline | | | Comparative assay:
Negative | | | Total |
|------------------------|--------------------------------|-----|----|----------------------------------|-----|----|--------------------------------|-----|----|-------|
| | R | BRD | NR | R | BRD | NR | R | BRD | NR | |
| European
Pediatrics | 16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 19 | 35 |
| US
Pediatrics | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 11 | 25 |
| Total | 29 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 30 | 60 |
| | Positive percent
agreement | 95% Exact
Confidence interval | Negative percent
agreement | 95% Exact
Confidence interval |
|-------|-------------------------------|----------------------------------|-------------------------------|----------------------------------|
| Total | 100%
(29/29) | 90.2 - 100 | 96.8%
(30/31) | 83.3 - 99.9 |
R: Reactive, NR: Nonreactive, BRD: Borderline
Including the combined US and European Sites, the positive percent agreement of the MONOLISA™ Anti-HAV EIA with the comparative anti-HAV assay was 99.5% (931/936) with a 95% exact confidence interval of 98.8% to 99.8%. The negative percent agreement of the MONOLISA™ Anti-HAV EIA with the comparative anti-HAV assay was 96.2% (378/393) with a 95% exact confidence interval of 93.8% to 97.9%.
Study On Vaccinated Subjects:
The HAV antibody response to vaccination was evaluated with 3 different vaccines that are currently licensed in the US: VAQTA® from Merck & Co, HAVRIX® 1440 from Glaxo SmithKline and TWINRIX® from Glaxo SmithKline.
For VAQTA® vaccine, 6 post-vaccination samples from US subjects were available.
For HAVRIX® vaccine, 10 matched sets of pre- and post-vaccination samples from European subjects and 8 post-vaccination samples from US subjects were available.
For TWINRIX® vaccine, 14 matched sets of pre-vaccination and post first dose samples from European individuals were available.
The following results were obtained:
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| | | | Comparative assay:
Positive
MONOLISA™ Anti-HAV EIA | | | Comparative assay:
Borderline
MONOLISA™ Anti- HAV EIA | | | Comparative assay:
Negative
MONOLISA™ Anti-HAV EIA | | | Total |
|---------|--------------------|--|----------------------------------------------------------|-----|----|-------------------------------------------------------------|-----|----|----------------------------------------------------------|-----|----|-------|
| | | | R | BRD | NR | R | BRD | NR | R | BRD | NR | |
| VAQTA | Post-vaccination | | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 |
| HAVRIX | Pre-vaccination | | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 10 |
| HAVRIX | Post-vaccination | | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 18 |
| TWINRIX | Pre-vaccination | | 1 | 0 | 0 | 0 | 0 | 0 | 1* | 0 | 12 | 14 |
| TWINRIX | Post 1st injection | | 9 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 14 |
Table 14: MONOLISA™ Anti-HAV EIA Results on Vaccinated Subjects versus the comparative assay - All testing sites
R : reactive, NR : Nonreactive , BRD : Borderline
- Result close to the cutoff value (CO/S=1.2)
In pre-vaccination samples, MONOLISA™ Anti-HAV EIA was in overall agreement with the comparative assay for 21/22 (95.5%) of samples tested.
For TWINRIX® vaccine on post first dose vaccination, MONOLISA™ Anti-HAV EIA demonstrated reactivity in 9/14 (64.3%) samples. The reference method demonstrated reactivity in 10/14 (71.4%) samples.
For HAVRIX® post-vaccination samples, MONOLISA™ Anti-HAV EIA demonstrated reactivity in 18/18 (100%) samples. The reference method demonstrated reactivity in 18/18 (100%) samples.
For VAQTA® post-vaccination samples, MONOLISA™ Anti-HAV EIA demonstrated reactivity in 6/6 (100%) samples. The reference method demonstrated reactivity in 6/6 (100%) samples.
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Seroconversion Panels
Six commercially available HAV seroconversion panels were tested using MONOLISA™ Anti-HAV EIA and the FDA approved comparative assay to determine the sensitivity of the assay. The results are summarized in the following table:
| Panel ID | MONOLISA™ Anti-
HAV EIA | Comparative assay | |
|----------|--------------------------------------------|--------------------------------------------|------------------------------------------|
| | Post bleed day of first
reactive result | Post bleed day of first
reactive result | Difference in Days to
Reactive result |
| 07467A | 0 | 0 | 0 |
| 60160K | 0 | 0 | 0 |
| HAV01 | 0 | 0 | 0 |
| RP-004 | 0 | 6 | - 6 |
| RP-013 | 8 | 8 | 0 |
| PHT902 | 16 | 16 | 0 |
Table 15: MONOLISA™Anti-HAV EIA Seroconversion Panels Results :
The sensitivity of the MONOLISA™ Anti-HAV EIA was equivalent to or more sensitive than the comparative assay in the six seroconversion panels tested.
Cross Reactivity Study
The potential for cross reactivity to other disease states, or viruses was evaluated for the MONOLISA™ Anti-HAV EIA Assay and the comparative assay.
In addition, samples containing rheumatoid factors, auto-antibodies, anti-mouse antibodies were tested.
In total, 255 specimens (including both serum and plasma) from 16 groups of potential crossreactivity were tested. FDA approved methods were used to confirm the disease state of each specimen.
The results are summarized in the following table.
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Table 16: Potential cross reactivity study
| Clinical Condition | Comparative assay Positive
MONOLISA™ Anti-HAV EIA | | | Comparative assay BRD
MONOLISA™ Anti-HAV EIA | | | Comparative assay Negative
MONOLISA™ Anti-HAV EIA | | | Total |
|------------------------------------|------------------------------------------------------|-----|----|-------------------------------------------------|-----|----|------------------------------------------------------|-----|-----|-------|
| | R | BRD | NR | R | BRD | NR | R | BRD | NR | |
| Hepatitis C (HCV) | 7 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 7 | 15 |
| Hepatitis B (HBV) HBs Ag | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 15 |
| Hepatitis B (HBV) anti HBc | 10 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 1 | 15 |
| Human Immunodeficiency Virus (HIV) | 6 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 7 | 15 |
| Epstein Barr Virus (EBV) IgG | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 13 | 15 |
| Epstein Barr Virus (EBV) IgM | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 15 |
| Cytomegalovirus (CMV) IgG | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 15 |
| Cytomegalovirus (CMV) IgM | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 15 |
| Rubella IgG | 5 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 9 | 15 |
| Toxoplasmosis IgG | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 15 |
| Toxoplasmosis IgM | 8 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 4 | 15 |
| Mumps IgG | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 11 | 15 |
| Varicella Zoster Virus(VZV) IgG | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 14 | 15 |
| Varicella Zoster Virus(VZV) IgM | 6 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 7 | 15 |
| Anti Nuclear Antibody (ANA) | 7 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 7 | 15 |
| Human Anti Mouse Antibody (HAMA) | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 12 | 15 |
| Rheumatoid Arthritis | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 15 |
| Total | 115 | 2 | 3 | 3 | 0 | 4 | 4 | 1 | 123 | 255 |
7 samples were discrepant: 4 reactive on MONOLISA™ Anti-HAV EIA, nonreactive on comparative assay and 3 were
nonreactive on MONOLISA™ Anti-HAV EIA and reactive on comparative
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Precision Study
Within-Laboratory Precision Study :
A 21-member panel was tested: serum samples with the 6 corresponding plasma samples (EDTA K2, EDTA K3, Sodium Citrate, Sodium Heparin, Lithium heparin, ACD) at 3 different levels (1 negative, 1 negative near the cutoff, 1 low positive near the cutoff) were tested on 1 lot, in duplicate, in 2 different runs per day (am and pm), by the same operator for a period of 20 days. The data were analyzed following the CLSI guidance EP5A2. The mean ratio, the Standard Deviation (SD) and percent coefficient of variation (%CV) were calculated for each panel member.
The data summary is shown in the following tables.
| Panel Member | N | Mean
CO/S | Within run¹ | | Between Run ² | | Between Day ³ | | Total ⁴ | |
|---------------------|----|--------------|-------------|--------|---------------|--------|---------------|--------|---------|--------|
| | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Negative Control C0 | 40 | 0.282 | NA | NA | 0.02 | 6.4% | 0.01 | 5.0% | 0.02 | 8.1% |
| Positive Control C1 | 40 | 4.093 | NA | NA | 0.54 | 13.5% | 0.00 | 0.0% | 0.49 | 12.3% |
| Serum 1 | 80 | 0.395 | 0.02 | 4.1% | 0.03 | 6.3% | 0.01 | 1.9% | 0.03 | 7.7% |
| EDTA K2 1 | 80 | 0.379 | 0.02 | 5.0% | 0.03 | 6.8% | 0.01 | 1.4% | 0.03 | 8.6% |
| EDTA K3 1 | 80 | 0.376 | 0.01 | 3.4% | 0.04 | 9.3% | 0.00 | 0.0% | 0.04 | 9.9% |
| Sodium Citrate 1 | 80 | 0.387 | 0.04 | 10.1% | 0.01 | 3.3% | 0.02 | 5.1% | 0.05 | 11.8% |
| Sodium Heparin 1 | 80 | 0.363 | 0.01 | 3.4% | 0.03 | 7.6% | 0.00 | 0.0% | 0.03 | 8.3% |
| Lithium Heparin 1 | 80 | 0.364 | 0.01 | 3.4% | 0.03 | 7.0% | 0.01 | 3.5% | 0.03 | 8.5% |
| ACD 1 | 80 | 0.402 | 0.02 | 4.3% | 0.04 | 10.4% | 0.00 | 0.0% | 0.05 | 11.3% |
| Serum 2 | 80 | 0.691 | 0.03 | 4.9% | 0.06 | 9.6% | 0.01 | 2.3% | 0.06 | 11.0% |
| EDTA K2 2 | 80 | 0.657 | 0.02 | 3.2% | 0.05 | 6.6% | 0.01 | 1.8% | 0.05 | 7.5% |
| EDTA K3 2 | 80 | 0.686 | 0.03 | 4.9% | 0.06 | 8.2% | 0.00 | 0.0% | 0.07 | 9.5% |
| Sodium Citrate 2 | 80 | 0.636 | 0.03 | 3.7% | 0.05 | 7.0% | 0.03 | 4.8% | 0.06 | 9.2% |
| Sodium Heparin 2 | 80 | 0.628 | 0.02 | 3.1% | 0.04 | 6.0% | 0.03 | 4.2% | 0.06 | 7.9% |
| Lithium Heparin 2 | 80 | 0.685 | 0.05 | 6.6% | 0.06 | 8.6% | 0.00 | 0.0% | 0.08 | 10.8% |
| ACD 2 | 80 | 0.746 | 0.04 | 5.6% | 0.05 | 6.4% | 0.03 | 4.7% | 0.07 | 9.7% |
| Serum 3 | 80 | 1.506 | 0.06 | 4.2% | 0.14 | 9.4% | 0.00 | 0.4% | 0.15 | 10.3% |
| EDTA K2 3 | 80 | 1.261 | 0.07 | 4.7% | 0.11 | 7.0% | 0.07 | 4.8% | 0.15 | 9.7% |
| EDTA K3 3 | 80 | 1.257 | 0.04 | 2.4% | 0.09 | 6.0% | 0.05 | 3.6% | 0.11 | 7.4% |
| Sodium Citrate 3 | 80 | 1.462 | 0.08 | 5.1% | 0.13 | 8.7% | 0.07 | 4.9% | 0.17 | 11.2% |
| Sodium Heparin 3 | 80 | 1.380 | 0.11 | 7.5% | 0.12 | 8.0% | 0.05 | 3.4% | 0.17 | 11.4% |
| Lithium Heparin 3 | 80 | 1.346 | 0.08 | 5.6% | 0.11 | 7.1% | 0.03 | 1.8% | 0.14 | 9.2% |
| ACD 3 | 80 | 1.344 | 0.05 | 3.4% | 0.08 | 5.6% | 0.09 | 6.0% | 0.13 | 8.9% |
Table 17: MONOLISA™ Anti-HAV EIA Precision Results by Panel Member Cutoff to Signal (CO/S)
NA : Not Applicable
1 Within Run: variability of the assay performance from replicate to replicate
2Between Run: variability of the assay performance from Run to Run
3 Between Day: variability of the assay performance from Day to Day
*Total :total variability of the assay performance includes within run, between run and between day.
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Reproducibility Study:
A 6 member panel consisting of diluted plasma specimens (negative and different levels of positive) was tested in triplicate, once a day for 3 days on 3 lots* of MONOLISA™ Anti-HAV EIA at 3 separate clinical trial sites. Each panel was coded with a different number on each day tested in order to blind the operator to the expected value of the sample.
*:3 different lots were used at the Bio-Rad site and 2 lots were used on each of the external sites.
The data from all reagent lots and sites were combined to obtain Standard Deviation (SD) and percent coefficient of variation (CV) for within run, between lot, between lot, between site and total variance. The data were analyzed according to the principles described in the Clinical Laboratory Standards Institute guidance EP5-A2, revised November 2004 and ISO/TR 22971:2005. The PROC GLM procedure in SAS® was used to estimate the variance components of the model. The model was y = site + lot (site) + day (lot site) + error.
The summaries are shown in the following tables.
Table 18: MONOLISA™ Anti-HAV EIA Reproducibility Results by Panel Member Cutoff to Signal (CO/S)
| Test
site | Panel
Member | N | Mean
CO/S | Within Run¹ | | Between Day² | | Between Lot³ | | Total⁴ | |
|--------------|-----------------|----|--------------|-------------|------|--------------|------|--------------|------|--------|------|
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Site
#1 | P1 | 18 | 0.33 | 0.01 | 3.03 | 0.09 | 28.1 | 0⁵ | 0 | 0.09 | 28.3 |
| | P2 | 18 | 0.68 | 0.03 | 4.9 | 0.07 | 10.0 | 0⁵ | 0 | 0.07 | 11.1 |
| | P3 | 18 | 1.02 | 0.05 | 5.0 | 0.05 | 5.2 | 0⁵ | 4.1 | 0.08 | 8.3 |
| | P4 | 18 | 1.98 | 0.09 | 4.7 | 0.32 | 16.0 | 0⁵ | 0 | 0.33 | 16.7 |
| | P5 | 18 | 2.48 | 0.18 | 7.4 | 0.36 | 14.8 | 0⁵ | 0 | 0.41 | 16.5 |
| | P6 | 18 | 3.66 | 0.23 | 6.2 | 0.20 | 5.5 | 0⁵ | 0 | 0.3 | 8.3 |
| Site#2 | P1 | 18 | 0.35 | 0.01 | 1.6 | 0.02 | 4.7 | 0.01 | 1.2 | 0.02 | 5.1 |
| | P2 | 18 | 0.92 | 0.03 | 3.0 | 0.07 | 8.0 | 0⁵ | 0 | 0.08 | 8.5 |
| | P3 | 18 | 1.28 | 0.04 | 3.5 | 0.00 | 0.0 | 0.01 | 0.62 | 0.05 | 3.6 |
| | P4 | 18 | 2.32 | 0.08 | 3.6 | 0.20 | 8.5 | 0.02 | 0.95 | 0.21 | 9.3 |
| | P5 | 18 | 3.10 | 0.13 | 4.1 | 0.20 | 6.4 | 0⁵ | 0 | 0.23 | 7.5 |
| | P6 | 18 | 4.16 | 0.13 | 3.2 | 0.36 | 8.7 | 0⁵ | 0 | 0.39 | 9.3 |
| Site
#3 | P1 | 27 | 0.36 | 0.01 | 4.0 | 0.02 | 5.4 | 0.02 | 6.6 | 0.03 | 9.4 |
| | P2 | 27 | 0.81 | 0.03 | 3.4 | 0.03 | 3.9 | 0.06 | 7.2 | 0.07 | 8.8 |
| | P3 | 27 | 1.27 | 0.08 | 6.6 | 0.04 | 3.6 | 0.14 | 11.2 | 0.17 | 13.5 |
| | P4 | 27 | 2.16 | 0.11 | 5.0 | 0.05 | 2.2 | 0.34 | 15.7 | 0.36 | 16.6 |
| | P5 | 27 | 3.09 | 0.11 | 3.7 | 0.15 | 4.9 | 0.49 | 15.7 | 0.52 | 16.9 |
| | P6 | 27 | 4.47 | 0.11 | 2.5 | 0.33 | 7.3 | 1.01 | 22.5 | 1.06 | 23.8 |
1 Within Run: variability of the assay performance from replicate to replicate
2Between Day: variability of the assay performance from Day to Day
3 Between Lot: variability of the assay performance from Lot to Lot
"Total : total variability of the assay performance includes within run, between day and between lot.
ً Negative variances were rounded to zero, per statistical convention.
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Table 19: MONOLISA™ Anti-HAV Reproducibility Summary by Panel Member Cutoff to Signal (CO/S)
| Panel Member | N | Mean | Within Run1 | Between Day2 | Between Lot3 | Between Site5 | Total4 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||
| P1 | 63 | 0.35 | 0.01 | 3.2 | 0.05 | 14.8 | 05 | 0 | 0.01 | 2.9 | 0.05 | 15.5 |
| P2 | 63 | 0.80 | 0.03 | 3.7 | 0.06 | 7.12 | 0.03 | 3.7 | 0.11 | 13.4 | 0.13 | 16.0 |
| P3 | 63 | 1.20 | 0.07 | 5.5 | 0.04 | 3.3 | 0.10 | 8.6 | 0.12 | 10.3 | 0.18 | 14.9 |
| P4 | 63 | 2.15 | 0.10 | 4.5 | 0.20 | 9.5 | 0.22 | 10.0 | 0.00 | 0.0 | 0.31 | 14.5 |
| P5 | 63 | 2.92 | 0.14 | 4.8 | 0.24 | 8.3 | 0.32 | 11.0 | 0.25 | 8.7 | 0.50 | 17.0 |
| P6 | 63 | 4.15 | 0.16 | 3.8 | 0.31 | 7.4 | 0.70 | 16.9 | 05 | 0 | 0.78 | 18.9 |
1 Within Run: variability of the assay performance from replicate to replicate
2Between Day: variability of the assay performance from Day to Day
3Between Lot: variability of the assay performance from Lot to Lot
*Between site: variability of the assay performance from Site to Site
"Total : total variability of the assay performance includes within run, between lot and between site.
Trotal . total variablity of the assuy performance includes within full,
5 Negative variances were rounded to zero, per statistical convention.
Reproducibility study on Negative and Positive Controls:
The negative and positive controls were tested in triplicate, once a day by 3 different operators for 3 days. The data were analyzed according to the principles described in the Clinical Laboratory Standards Institute guidance EP5-A2, revised November 2004 and ISO/TR 22971:2005.
Table 20: MONOLISA™ Anti-HAV EIA Control Reproducibility summary by Operator (CO/S)
| Samples | N | Mean | Within Run1 | | Between Day2 | | Between
Operator 3 | | Total4 | |
|------------------|----|------|-------------|-----|--------------|------|-----------------------|-----|--------|------|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Negative Control | 27 | 0.30 | 0.01 | 2.6 | 0.02 | 8.3 | 05 | 0 | 0.03 | 8.7 |
| Positive Control | 27 | 4.74 | 0.16 | 3.5 | 0.48 | 10.1 | 0.07 | 1.5 | 0.51 | 10.8 |
1 Within Run: variability of the assay performance from replicate to replicate
2Between Day: variability of the assay performance from Day to Day
3 Between operator: variability of the assay performance from Operator to Operator
*Total :total variability of the assay performance includes within run, between day and between Operator.
5 Negative variances were rounded to zero, per statistical convention.
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Image /page/22/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with three wavy lines forming its body and wings, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Manuela Kaul RA-Manager Bio-Rad France 3, Boulevard Raymond Poincaré 92430 Marnes-la-Coquette, France
MAY - 3 2007
Re: K063318
Trade/Device Name: MONOLISA™ Anti-HAV EIA Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A Virus (HAV) Serological Reagents Regulatory Class: Class II Product Code: LOL Dated: March 21, 2007 Received: April 3, 2007
Dear Ms. Kaul:
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. Ilsting 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 (OS) regulation (21 CFR Part 820).
23
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 a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Kaily att
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Devices Evaluation and Safety Center for Devices and Radiological Health
Enclosure
24
INDICATIONS FOR USE STATEMENT
510(k) Number : K 063318
MONOLISA™ Anti-HAV EIA Device Name:
Indications for Use:
The MONOLISA™ Anti-HAV EIA is an in vitro enzyme immunoassay kit intended for use in the qualitative detection of total antibodies (IgG and IgM) to Hepatitis A Virus (anti-HAV) in human (adult and pediatric) serum or plasma (EDTA, Heparin, Citrate, ACD). This kit can be used as an aid in the diagnosis of acute or past Hepatitis A Virus (HAV) infection or as an aid in the identification of HAVsusceptible individuals for vaccination. However, any diagnosis should take into consideration the patient's clinical history and symptoms, as well as serological data.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, and cord blood or neonatal specimens.
WARNING : This assay is not intended for screening blood or solid or soft tissue donors.
Prescription Use: ___ X (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use: (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Faisano
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
51000 K063318