(182 days)
P890014
Not Found
No
The device description and performance studies describe a standard enzyme immunoassay (EIA) with spectrophotometric measurement and comparison to a cutoff value. There is no mention of AI, ML, or any computational analysis beyond basic comparison to a threshold.
No
Explanation: This device is an in vitro diagnostic (IVD) test intended for the qualitative detection of IgM antibodies to Hepatitis A virus. It provides diagnostic information but does not directly treat or prevent a disease, which is the function of a therapeutic device.
Yes
The intended use explicitly states that the assay results, in conjunction with other information, "may be used for the laboratory diagnosis of individuals with acute or recent Hepatitis A." This directly indicates a diagnostic purpose.
No
The device is an in vitro diagnostic (IVD) kit that includes reagents and other physical components for performing an enzyme immunoassay. It is 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 device is an "in vitro enzyme immunoassay kit intended for use in the qualitative detection of IgM antibodies to Hepatitis A virus (anti-HAV IgM) in human (adult and pediatric) serum or plasma". This clearly indicates that the device is used outside of the body to analyze biological specimens for diagnostic purposes.
- Device Description: The description details a laboratory-based assay procedure involving the analysis of patient specimens (serum or plasma) using chemical reactions and spectrophotometric measurement. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document describes clinical performance studies, seroconversion panel testing, cross-reactivity studies, and precision studies, all of which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a "Predicate Device(s)" with a PMA Number (P890014) further confirms that this device is being compared to an already approved IVD.
Therefore, based on the provided information, the MONOLISA™ Anti-HAV IgM EIA is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MONOLISA™ Anti-HAV IgM EIA is an in vitro enzyme immunoassay kit intended for use in the qualitative detection of IgM antibodies to Hepatitis A virus (anti-HAV IgM) 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 IgM EIA kit is indicated for testing specimens from individuals who have signs and symptoms consistent with acute Hepatitis. Assay results, in conjunction with other serological or clinical information, may be used for the laboratory diagnosis of individuals with acute or recent Hepatitis A.
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 IgM EIA is an enzyme immunoassay (IgM antibody capture format) for the detection of IgM antibodies to Hepatitis A Virus. In the assay procedure, patient specimens, a calibrator, and controls are incubated with anti-human IgM antibodies coated on the microwells. If IgM antibodies to HAV are present in a specimen or control, they bind to the antibody. Excess sample is removed by a wash step. The HAV Viral Antigen and the Containing horseradish peroxidase - labeled mouse monoclonal antibody to HAV) are successively added to the microwells and allowed to incubate. The presence of IgM anti-HAV in the sample enables the HAV Viral Antigen and the Conjugate to bind to the solid phase. Excess Conjugate and HAV Viral Antigen are removed by a wash step, and a TMB Chromogen / Substrate solution is added to the microwells and allowed to incubate. If a sample contains anti-HAV IgM, the bound enzyme (HRP) causes the colorless TMB in the Chromogen solution to change to blue. The blue color turns yellow after the addition of a Stopping Solution. If a sample does not contain anti-HAV IgM, 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,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
A multi-center prospective and retrospective study was conducted to evaluate the clinical performance of the MONOLISA™ Anti-HAV IgM EIA assay among individuals with signs or symptoms and those at high risk for Hepatitis infection.
Sample size: 404 specimens collected in the US and 929 specimens collected in Europe (France and Italy).
The US population consisted of 174 subjects with signs and symptoms of Hepatitis. In this group, 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 the remaining 1.1% represented by multiple ethnic groups. The ethnicity of 36.8% was unknown. Among these 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), 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. In this group, 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 253 specimens collected from patients with signs and symptoms of Hepatitis. In this group, 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).
There were 345 specimens from an asymptomatic hospitalized population and 34 were from healthcare workers (for HAV pre-vaccination screening). One hundred and fifty one (151) patients had recovered HAV infection. Among these 845 european samples, 36 (4.3%) were from pediatric subjects.
The results obtained with MONOLISA™ Anti-HAV IgM 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 IgM 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 IgM EIA were considered as false positives for MONOLISA™ Anti-HAV IgM EIA assay
- Specimens that were borderline with the comparative assay and non reactive with MONOLISA™ Anti-HAV IgM EIA were considered as false negatives for MONOLISA™ Anti-HAV IgM EIA
Summary of Performance Studies
Study type: Clinical Performance, Seroconversion Panels, Cross Reactivity Study, Precision Study, Reproducibility Study.
Sample size:
Clinical Performance: 404 US subjects, 929 European subjects.
Seroconversion Panels: 8 commercially available HAV seroconversion panels.
Cross Reactivity Study: 255 specimens from 16 groups of potential cross reactivity.
Precision Study: A 21-member panel (serum samples with 6 corresponding plasma samples at 3 different levels). 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.
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 IgM EIA at 3 separate clinical trial sites. Negative and positive controls tested in triplicate, once a day by 3 different operators for 3 days.
Key results:
Clinical Performance (Percent Agreement):
US population (N=404):
- Positive percent agreement: 100% (1/1)
- Negative percent agreement: 99.3% (400/403), 95% Exact Confidence Interval: 97.8-99.9%
European population (N=845): - Positive percent agreement: 100% (1/1)
- Negative percent agreement: 99.0% (836/844), 95% Exact Confidence Interval: 98.1-99.6
Acute HAV Infection (N=84): - Positive agreement: 100% (84/84), 95% exact confidence interval of 96.5% to 100%.
Pediatric Subjects (N=61): - Positive percent agreement: 0% (N/A)
- Negative percent agreement: 96.7% (59/61), 95% Exact Confidence Interval: 88.6 - 99.6
Overall (Combined US and European Sites): - Positive percent agreement: 100% (86/86), 95% exact confidence interval of 96.6% to 100%.
- Negative percent agreement: 99.1% (1233/1244), 95% exact confidence interval of 98.4% to 99.6%.
Seroconversion Panels: For all seroconversion panels, both MONOLISA™ Anti-HAV IgM EIA and the comparative assay detected HAV IgM antibodies at the same first bleed. MONOLISA™ Anti-HAV IgM EIA appears to detect IgM for a longer period than the comparator assay for qualitative determination of IgM antibody to Hepatitis A.
Cross Reactivity Study: All 255 specimens were found nonreactive with HAV IgM with MONOLISA™ Anti-HAV IgM and with the predicate assay.
Precision Study: Details on mean S/CO, Standard Deviation (SD) and percent coefficient of variation (%CV) for within-run, between-run, between-day, and total variability provided in Table 16.
Reproducibility Study: Reproducibility results by panel member Signal to Cutoff (S/CO) at three test sites and overall summary are provided in Tables 17 and 18, respectively. Negative and positive control reproducibility summary by operator is provided in Table 19.
- Total CV% ranges from 8.1% to 74.6% for Site #1, 7.5% to 15.4% for Site #2, and 8.0% to 18.7% for Site #3 across panel members.
- Overall total CV% ranges from 10.1% to 43.3% across panel members.
- Negative Control total CV% = N/A, Positive Control total CV% = 4.17%.
Key Metrics
Sensitivity: Not explicitly stated as "sensitivity" but positive percent agreement reported (100%).
Specificity: Not explicitly stated as "specificity" but negative percent agreement reported (ranges from 96.7% to 99.3%).
PPV: Not Found
NPV: Not Found
AUC: Not Found
MRMC: Not Found
Predicate Device(s)
DiaSorin ETI-HA-IGMK PLUS PMA Number : P890014
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 is in black and white and features the text "BIO-RAD" in a bold, sans-serif font. The text is enclosed in a rounded rectangle.
MONOLISA™ Anti-HAV IgM 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 063319 |
|---|---|
| 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 | |
| CLASSIFICATION NAME: | Hepatitis A Test (IgM Antibody) |
| COMMON NAME: | IgM Antibody to Hepatitis A Virus |
| PRODUCT TRADE NAME: | MONOLISA™ Anti-HAV IgM EIA |
| DEVICE CLASS : | Class II LOL |
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. The logo is in a rounded rectangle shape, with the words "BIO+RAD" in white letters against a black background. The plus sign is slightly smaller than the other letters.
CLASSIFICATION PANEL :
Immunology and Microbiology Devices
REGULATION NUMBER : 21 CFR 866.3310
LEGALLY MARKETED EQUIVALENT (SE) DEVICE
DiaSorin ETI-HA-IGMK PLUS PMA Number : P890014 Decision Date : 12/14/2005
DEVICE DESCRIPTION
The MONOLISA™ Anti-HAV IgM EIA is an enzyme immunoassay (IgM antibody capture format) for the detection of IgM antibodies to Hepatitis A Virus. In the assay procedure, patient specimens, a calibrator, and controls are incubated with anti-human IgM antibodies coated on the microwells. If IgM antibodies to HAV are present in a specimen or control, they bind to the antibody. Excess sample is removed by a wash step. The HAV Viral Antigen and the Containing horseradish peroxidase - labeled mouse monoclonal antibody to HAV) are successively added to the microwells and allowed to incubate. The presence of IgM anti-HAV in the sample enables the HAV Viral Antigen and the Conjugate to bind to the solid phase. Excess Conjugate and HAV Viral Antigen are removed by a wash step, and a TMB Chromogen / Substrate solution is added to the microwells and allowed to incubate. If a sample contains anti-HAV IgM, the bound enzyme (HRP) causes the colorless TMB in the Chromogen solution to change to blue. The blue color turns yellow after the addition of a Stopping Solution. If a sample does not contain anti-HAV IgM, 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,
2
Image /page/2/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 is in white text on a black background. The words "BIO" and "RAD" are separated by a plus sign.
KIT COMPONENTS
| Component | Description |
|---|---|
| R1 Microwell Strip Plates | Two (2) x 12 strips of 8 wells coated with polyclonal anti-human IgM |
| antibodies. | |
| R2 Wash Solution | |
| Concentrate (30x) | One (1) 120 mL bottle, Tris buffer containing NaCl and Tween 20. |
| C0 Negative Control | One (1) 1 mL vial, containing human plasma, negative for IgM anti- |
| HAV antibodies, total anti-HAV antibodies, HBs antigen, anti-HCV | |
| antibodies and anti-HIV-1/HIV-2 antibodies. Preservatives: Sodium | |
| azide (=90 | Female |
| Male | |
| Total |
Table 5: Expected Results for MONOLISA™ Anti-HAV IqM EIA in subjects from the Mid-West US (N= 280)
*1 subject was reactive with a result of 2.25 (S/CO)
** 1 subject gave an initial borderline result of 1.04 (S/CO).
8
Image /page/8/Picture/0 description: The image shows the logo for BIO-RAD. The logo is white text on a black background. The text is in a bold, sans-serif font. The logo is enclosed in a rounded rectangle.
| MONOLISA™ Anti-HAV IgM EIA | ||||||||
|---|---|---|---|---|---|---|---|---|
| Age Range | Gender | Reactive N | Reactive % | Borderline N | Borderline % | Nonreactive N | Nonreactive % | 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 | 1* | 0.4% | 1** | 0.4% | 243 | 99.2% | 245 |
・
Table 6: Expected Results for MONOLISA™ Anti-HAV IgM EIA in subjects from the Western US (N= 245)
*1 subject was reactive with a result of 1.34 (S/CO)
*1 subject was reactive with a result of 1.34 (S/CO)
** 1 subject gave an initial borderline result of 0.96 (S/CO).
9
Image /page/9/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. The logo is white text on a black background. The text is in a bold, sans-serif font. The words "BIO" and "RAD" are separated by a plus sign. The logo is enclosed in a rounded rectangle.
| MONOLISA™ Anti-HAV IgM EIA | ||||||||
|---|---|---|---|---|---|---|---|---|
| Gender | Reactive | Borderline | Nonreactive | |||||
| Age Range | N | % | N | % | N | % | Total | |
| 80 | Female | 0 | N/A | 0 | N/A | 0 | N/A | 0 |
| Male | 0 | N/A | 0 | N/A | 0 | N/A | 0 | |
| Total | 0 | N/A | 0 | N/A | 62 | 100.0% | 62 |
11
Image /page/11/Picture/0 description: The image shows the logo for Bio-Rad. The logo is in white text on a black background. The text is bold and sans-serif.
PERFORMANCE CHARACTERISTICS
Clinical Performance
A multi-center prospective and retrospective study was conducted to evaluate the clinical performance of the MONOLISA™ Anti-HAV IgM EIA assay among individuals with signs or symptoms and those at high risk for Hepatitis infection. Specimens were collected in 3 different geographical areas: 404 specimens were collected in the US and 929 were collected in Europe (France and Italy).
The US population consisted of 174 subjects with signs and symptoms of Hepatitis. In this group, 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 the remaining 1.1% represented by multiple ethnic groups. The ethnicity of 36.8% was unknown. Among these 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), 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. In this group, 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 253 specimens collected from patients with signs and symptoms of Hepatitis. In this group, 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).
There were 345 specimens from an asymptomatic hospitalized population and 34 were from healthcare workers (for HAV pre-vaccination screening),
One hundred and fifty one (151) patients had recovered HAV infection.
Among these 845 european samples, 36 (4.3%) were from pediatric subjects.
Percent Agreement
The results obtained with MONOLISA™ Anti-HAV IgM 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 IgM EIA and the comparative assay were calculated.
To determine the percent agreement on borderline results the following criteria were used:
- 프 Specimens that were borderline with the comparative assay and reactive with MONOLISA™ Anti-HAV IgM EIA were considered as false positives for MONOLISA™ Anti-HAV IgM EIA assay
- a Specimens that were borderline with the comparative assay and non reactive with MONOLISA™ Anti-HAV IgM EIA were considered as false negatives for MONOLISA™ Anti-HAV IgM EIA
The results obtained with the US specimens and with the European specimens are presented in the following tables:
12
Image /page/12/Picture/0 description: The image shows the logo for Bio-Rad. The text "BIO+RAD" is written in white, bold, sans-serif font. The text is set against a black, rounded rectangle.
Table 10: MONOLISA™ Anti-HAV IgM EIA versus the comparative assay results in the US population (N=404)
| Subject
category | Comparative assay:
Positive
MONOLISA™ Anti-
HAV IgM EIA | | | Comparative assay :
Borderline
MONOLISA™ Anti-
HAV IgM EIA | | | Comparative assay:
Negative
MONOLISA™ Anti-
HAV IgM EIA | | | Total |
|---------------------------------------------|------------------------------------------------------------------|-----|----|---------------------------------------------------------------------|-----|----|------------------------------------------------------------------|------|-----|-------|
| | R | BRD | NR | R | BRD | NR | R | BRD | NR | |
| Subjects with
signs and
symptoms | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 171 | 174 |
| Subjects with
high risk for
Hepatitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 229 | 230 |
| Total | 1 | 0 | 0 | 0 | 0 | 0 | 2b | 1a b | 400 | 404 |
R: Reactive, NR: Nonreactive, BRD : Borderline
³: the borderline sample with MONOLISA was considered as "false positive"
b: these samples were found HAV IgG reactive.
| | Positive percent
agreement | 95% Exact
Confidence interval | Negative percent
agreement | 95% Exact
Confidence interval |
|-------|-------------------------------|----------------------------------|-------------------------------|----------------------------------|
| Total | 100%
(1/1) | NA | 99.3%
(400/403) | 97.8-99.9% |
Table 11: MONOLISA™ Anti-HAV IgM EIA versus the comparative assay results in the European population (N= 845)
| | Comparative
assay: Positive
MONOLISA™
Anti-HAV IgM
EIA | | | Comparative
assay: Borderline
MONOLISA™
Anti-HAV IgM
EIA | | | Comparative
assay: Negative
MONOLISA™
Anti-HAV IgM
EIA | | | Total |
|---------------------------------------------|--------------------------------------------------------------------|-----|----|----------------------------------------------------------------------|-----|----|--------------------------------------------------------------------|-----|-----|-------|
| Subject
category | R | BRD | NR | R | BRD | NR | R | BRD | NR | |
| General
hospitalized
population | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1b | 342 | 345 |
| Sign /
Symptoms of
Hepatitis | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 250 | 253 |
| Subjects with
high risk for
Hepatitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 62 | 62 |
| Healthcare
workers | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 34 | 34 |
| Infected/
recovered HAV | 0 | 0 | 0 | 2a | 0 | 0 | 1 | 0 | 148 | 151 |
13
Image /page/13/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. The logo is white text on a black background. The text is in a bold, sans-serif font. The logo is enclosed in a rounded rectangle.
| Company of Children College
1
and the first of the first of the first of the first of the first of the first of the first for the first for the first and
THE LEASE | AND LABOR | | THE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LE | -----
C
Company of the results of the results of the results of the first of the first of the first of the first of the first of the first the first the first the first the first the | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------- | ***
Access Accessful and | 11 16 100
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1
845
| A Property (4) 4 (4) 4) |
|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| | Positive percent
agreement | 95% Exact
Confidence interval | Negative percent
agreement | 95% Exact
Confidence interval |
|-------|-------------------------------|----------------------------------|-------------------------------|----------------------------------|
| Total | 100%
(1/1) | N/A | 99.0%
(836/844) | 98.1-99.6 |
R: Reactive, NR: Nonreactive, BRD : Borderline
ª the 2 borderline samples with the comparative assay were considered "false positive" with MONOLISA
b: the borderline sample with MONOLISA was considered as "false positive"
°; these samples were found HAV IgG Reactive
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:
| Table 12 : Comparison of Results for MONOLISA™ Anti-HAV IgM EIA versus the | |||
|---|---|---|---|
| comparative assay on Acute HAV infection in the adult and pediatric European | |||
| Population (N= 84) : |
| Comparative assay: Positive | Comparative assay: Borderline | Comparative assay : Negative | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| MONOLISA™ Anti-HAV IgM EIA | MONOLISA™ Anti-HAV IgM EIA | MONOLISA™ Anti-HAV IgM 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-one (61) pediatric samples were tested during the US and European clinical studies in addition to the 39 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, 23 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.
14
Image /page/14/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 is in white text on a black background. The text is bold and sans-serif. The logo is simple and recognizable.
Table 13 : Comparison of Results for MONOLISA™ Anti-HAV IgM EIA versus the comparative assay in the Pediatric European and US Population (N= 61)
| Subject category | Comparative assay: Positive
MONOLISATM Anti-HAV IgM EIA | | | Comparative assay: Borderline
MONOLISATM Anti-HAV IgM EIA | | | Comparative assay : Negative
MONOLISATM Anti-HAV IgM EIA | | | Total |
|---------------------|------------------------------------------------------------|-----|----|--------------------------------------------------------------|-----|----|-------------------------------------------------------------|-----|----|-------|
| | R | BRD | NR | R | BRD | NR | R | BRD | NR | |
| European pediatrics | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 35 | 36 |
| US pediatrics | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 24 | 25 |
| Total | 0 | 0 | 0 | 0 | 0 | 0 | 2a | 0 | 59 | 61 |
R: Reactive, NR: Nonreactive, BRD : Borderline
³: these samples were found HAV IgG Reactive
| | Positive percent
agreement | 95% Exact
Confidence interval | Negative percent
agreement | 95% Exact
Confidence interval |
|-------|-------------------------------|----------------------------------|-------------------------------|----------------------------------|
| Total | 0 | N/A | 96.7%
(59/61) | 88.6 - 99.6 |
Including the combined US and European Sites, the positive percent agreement of the MONOLISA™ Anti-HAV IgM EIA with the comparative assay was 100% (86/86), with a 95% exact confidence interval of 96.6% to 100%. The negative percent agreement of the MONOLISA™ Anti-HAV IgM EIA with the comparative assay was 99.1% (1233/1244) with a 95% exact confidence interval of 98.4% to 99.6%.
15
Image /page/15/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 is white text on a black background. The text is in a bold, sans-serif font. The logo is enclosed in a rounded rectangle.
Seroconversion Panels
Eight commercially available HAV seroconversion panels were tested using MONOLISA™ Anti-HAV IgM EIA and the comparative assay to determine the sensitivity of the assay. The results are summarized in the following table:
| Panel ID | MONOLISA™ Anti-
HAV IgM EIA | Anti-HAV IgM
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 |
| 60162K | 0 | 0 | 0 |
| HAV01 | 0 | 0 | 0 |
| RP-004 | 6 | 6 | 0 |
| RP-013 | 8 | 8 | 0 |
| PHT901 | 12 | 12 | 0 |
| PHT902 | 16 | 16 | 0 |
Table 14: MONOLISA™Anti-HAV IgM EIA Seroconversion panels Results
| Panel ID | MONOLISA™ Anti-HAV
IgM EIA | Anti-HAV IgM
Comparative Assay | |
|----------|--------------------------------------------|--------------------------------------------|----------------------------------------------------|
| | Post bleed day of last
reactive result* | Post bleed day of last
reactive result* | Difference in Days
from last Reactive
result |
| HAV01 | 91a | 77 | +14 |
a: last bleed of the panel
For all seroconversion panels, both MONOLISA™ Anti-HAV IgM EIA and the comparative assay detected HAV IgM antibodies at the same first bleed. MONOLISA™ Anti-HAV IgM EIA appears to detect IgM for a longer period than the comparator assay for qualitative determination of IgM antibody to Hepatitis A.
Among seroconversion panels beginning with samples negative for antibodies and having subsequent samples to 5-6 months, one (PHT-902) becomes borderline after 5 months and one (PHT-901) gives a negative result after more than 20 months. Another seroconversion panel (RP-013) with samples collected through 6 months has a declining ratio but still remains positive. The other panels contain members collected through 2 to 3 months.
16
Image /page/16/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. The logo is in a rounded rectangle shape with the words "BIO+RAD" in bold, white letters against a black background. The plus sign is slightly raised and smaller than the other letters.
Cross Reactivity Study
The potential for cross reactivity to other disease states, or viruses was evaluated for the MONOLISA™ Anti-HAV IgM EIA Assay. In addition, samples containing rheumatoid factors, autoantibodies, anti-mouse antibodies were tested.
In total, 255 specimens (including both serum and plasma) from 16 groups of potential cross reactivity were tested. FDA approved methods were used to confirm the disease state of each specimen. All the samples were found negative on another commercially Anti-HAV IgM assay. The results are summarized in the following table:
| Clinical condition | Number
tested | MONOLISA™
Anti-HAV IgM EIA
nonreactive |
|------------------------------------|------------------|----------------------------------------------|
| Hepatitis C (HCV) | 15 | 15 |
| Hepatitis B (HBV) HBs Ag | 15 | 15 |
| Hepatitis B (HBV) anti HBc | 15 | 15 |
| Human Immunodeficiency Virus (HIV) | 15 | 15 |
| Epstein Barr Virus (EBV) IgG | 15 | 15 |
| Epstein Barr Virus (EBV) IgM | 15 | 15 |
| Cytomegalovirus (CMV) IgG | 15 | 15 |
| Cytomegalovirus (CMV) IgM | 15 | 15 |
| Rubella IgG | 15 | 15 |
| Toxoplasmosis IgG | 15 | 15 |
| Toxoplasmosis IgM | 15 | 15 |
| Mumps IgG | 15 | 15 |
| Varicella Zoster Virus(VZV) IgG | 15 | 15 |
| Varicella Zoster Virus(VZV) IgM | 15 | 15 |
| Anti Nuclear Antibody (ANA) | 15 | 15 |
| Human Anti Mouse Antibody (HAMA) | 15 | 15 |
| Rheumatoid Arthritis | 15 | 15 |
| Total Samples tested | 255 | 255 |
Table 15: Potential cross reactivity study
All the 255 specimens were found nonreactive with HAV IgM with MONOLISA™ Anti-HAV IgM and with the predicate assay.
17
Image /page/17/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black, rounded rectangle. The text is bold and sans-serif.
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 table:
| Table 16: MONOLISA™ Anti-HAV IgM EIA Precision Results by Panel Member Signal to | |||
|---|---|---|---|
| Cutoff (S/CO) |
| Panel Member | N | Mean S/CO | Within run¹ | Between Run ² | Between Day ³ | Total ⁴ | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | |||
| Negative Control C0 | 40 | 0.08 | NA | NA | 0.01 | 11.0% | 0.00 | 0.8% | 0.01 | 11.0% |
| Positive Control C1 | 40 | 2.03 | NA | NA | 0.08 | 4.2% | 0.05 | 2.5% | 0.10 | 4.8% |
| serum 1 | 80 | 0.05 | 0.00 | 5.5% | 0.01 | 14.1% | 0.00 | 7.7% | 0.01 | 17.0% |
| EDTA K2 1 | 80 | 0.05 | 0.00 | 6.3% | 0.01 | 13.4% | 0.00 | 6.4% | 0.01 | 16.1% |
| EDTA K3 1 | 80 | 0.05 | 0.00 | 6.3% | 0.01 | 15.2% | 0.00 | 4.6% | 0.01 | 17.1% |
| Sodium Citrate 1 | 80 | 0.05 | 0.00 | 6.7% | 0.01 | 14.0% | 0.00 | 0.0% | 0.01 | 15.5% |
| Sodium Heparin 1 | 80 | 0.05 | 0.00 | 6.7% | 0.01 | 12.6% | 0.00 | 5.6% | 0.01 | 15.4% |
| Lithium Heparin 1 | 80 | 0.05 | 0.00 | 6.7% | 0.01 | 14.5% | 0.00 | 7.6% | 0.01 | 17.7% |
| ACD A | 80 | 0.05 | 0.00 | 6.3% | 0.01 | 14.0% | 0.00 | 0.4% | 0.01 | 15.3% |
| Serum 2 | 80 | 0.55 | 0.02 | 3.7% | 0.02 | 4.0% | 0.02 | 3.6% | 0.04 | 6.5% |
| EDTA K2 2 | 80 | 0.66 | 0.02 | 3.5% | 0.03 | 4.9% | 0.03 | 5.3% | 0.05 | 8.0% |
| EDTA K3 2 | 80 | 0.65 | 0.02 | 3.3% | 0.04 | 6.1% | 0.03 | 4.7% | 0.05 | 8.3% |
| Sodium Citrate 2 | 80 | 0.65 | 0.03 | 5.0% | 0.03 | 5.0% | 0.02 | 3.8% | 0.05 | 8.0% |
| Sodium Heparin 2 | 80 | 0.57 | 0.01 | 2.5% | 0.02 | 3.7% | 0.03 | 4.8% | 0.04 | 6.6% |
| Lithium Heparin 2 | 80 | 0.57 | 0.02 | 2.7% | 0.04 | 6.1% | 0.02 | 4.0% | 0.05 | 7.8% |
| ACD 2 | 80 | 0.68 | 0.03 | 5.2% | 0.04 | 6.3% | 0.03 | 4.4% | 0.06 | 9.2% |
| Serum 3 | 80 | 1.33 | 0.03 | 2.1% | 0.06 | 4.8% | 0.06 | 5.2% | 0.09 | 7.4% |
| EDTA K2 3 | 80 | 1.44 | 0.03 | 2.5% | 0.06 | 4.8% | 0.06 | 4.7% | 0.09 | 7.2% |
| EDTA K3 3 | 80 | 1.35 | 0.07 | 6.2% | 0.07 | 5.4% | 0.05 | 4.5% | 0.11 | 9.4% |
| Sodium Citrate 3 | 80 | 1.44 | 0.04 | 3.1% | 0.05 | 4.2% | 0.06 | 5.2% | 0.09 | 7.4% |
| Sodium Heparin 3 | 80 | 1.36 | 0.02 | 2.1% | 0.06 | 5.1% | 0.06 | 4.7% | 0.09 | 7.2% |
| Lithium Heparin 3 | 80 | 1.35 | 0.05 | 4.1% | 0.07 | 5.8% | 0.05 | 4.3% | 0.10 | 8.3% |
| ACD 3 | 80 | 1.47 | 0.04 | 3.5% | 0.10 | 8.4% | 0.06 | 5.1% | 0.13 | 10.5% |
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
3Between Day: variability of the assay performance from Day to Day
"Total :total :total variability of the assay performance includes within run, between day.
18
Image /page/18/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black rounded rectangle. The text is in a bold, sans-serif font.
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 IgM 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 17: MONOLISA™ Anti-HAV IgM ETA Reproducibility Results by Panel Member Signal to Cutoff (S/CO)
| Test
site | Panel
Member | N | Mean
S/CO | | | Within Run1 | | Between Day2 | | Between Lot3 | | Total4 | |
|--------------|-----------------|----|--------------|--|--|-------------|------|--------------|------|--------------|------|--------|------|
| | | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Site #1 | P1 | 18 | 0.05 | | | 0.03 | 74.6 | 05 | 0 | 05 | 0 | 0.03 | 74.6 |
| | P2 | 18 | 0.69 | | | 0.03 | 4.7 | 0.06 | 8.1 | 05 | 0 | 0.06 | 9.4 |
| | P3 | 18 | 1.10 | | | 0.04 | 3.6 | 0.07 | 6.7 | 05 | 0 | 0.08 | 7.6 |
| | P4 | 18 | 1.69 | | | 0.05 | 2.7 | 0.13 | 7.6 | 05 | 0 | 0.14 | 8.1 |
| | P5 | 18 | 3.26 | | | 0.07 | 2.2 | 0.03 | 1.1 | 05 | 0 | 0.08 | 2.4 |
| | P6 | 18 | 4.19 | | | 0.19 | 4.6 | 0.00 | 0.0 | 0.05 | 1.1 | 0.20 | 4.7 |
| Site#2 | P1 | 18 | 0.06 | | | 0.00 | 6.4 | 0.01 | 12.2 | 0.00 | 6.7 | 0.01 | 15.4 |
| | P2 | 18 | 0.82 | | | 0.02 | 2.8 | 0.06 | 7.0 | 05 | 0 | 0.06 | 7.5 |
| | P3 | 18 | 1.27 | | | 0.05 | 3.8 | 0.08 | 6.6 | 0.11 | 8.6 | 0.15 | 11.5 |
| | P4 | 18 | 2.01 | | | 0.12 | 5.7 | 0.14 | 7.0 | 05 | 0 | 0.18 | 9.1 |
| | P5 | 18 | 3.8 | | | 0.15 | 4.0 | 0.20 | 5.2 | 05 | 0 | 0.25 | 6.6 |
| | P6 | 18 | 4.8 | | | 0.14 | 2.8 | 0.38 | 7.9 | 05 | 0 | 0.40 | 8.3 |
| Site #3 | P1 | 27 | 0.04 | | | 0.00 | 6.7 | 0.01 | 13.0 | 0.00 | 11.7 | 0.01 | 18.7 |
| | P2 | 27 | 0.71 | | | 0.02 | 3.3 | 0.03 | 4.0 | 0.04 | 6.1 | 0.06 | 8.0 |
| | P3 | 27 | 1.12 | | | 0.05 | 4.3 | 0.02 | 2.1 | 0.09 | 7.7 | 0.10 | 9.1 |
| | P4 | 27 | 1.77 | | | 0.06 | 3.4 | 0.08 | 4.3 | 0.10 | 5.8 | 0.14 | 8.0 |
| | P5 | 27 | 3.26 | | | 0.09 | 2.8 | 0.10 | 3.1 | 0.13 | 4.0 | 0.19 | 5.8 |
| | P6 | 27 | 3.93 | | | 0.10 | 2.6 | 0.10 | 2.5 | 0.20 | 5.1 | 0.25 | 6.3 |
1 Within Run: variability of the assay performance from replicate to replicate
4Between Day: variability of the assay performance from Day to Day
3Between 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.
5: Negative variances were rounded to zero, per statistical convention.
19
Image /page/19/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. 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. The logo is simple and modern.
Table 18: MONOLISA™ Anti-HAV IgM EIA Reproducibility summary by Panel Member Signal to Cutoff (S/CO).
| Panel
Member | N | Mean
S/CO | Within Run¹ | | Between Day² | | Between Lot³ | | Between Site⁵ | | Total⁴ | |
|-----------------|----|--------------|-------------|------|--------------|-----|--------------|-----|---------------|------|--------|------|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| P1 | 63 | 0.05 | 0.02 | 37.8 | 0.00 | 0.0 | 0.00 | 8.1 | 0.01 | 19.6 | 0.02 | 43.3 |
| P2 | 63 | 0.74 | 0.03 | 3.6 | 0.05 | 6.4 | 0.02 | 2.6 | 0.06 | 8.0 | 0.08 | 11.1 |
| P3 | 63 | 1.16 | 0.05 | 3.9 | 0.06 | 5.3 | 0.08 | 6.8 | 0.07 | 5.8 | 0.13 | 11.1 |
| P4 | 63 | 1.82 | 0.08 | 4.2 | 0.11 | 6.3 | 0.05 | 3.0 | 0.15 | 8.1 | 0.21 | 11.5 |
| P5 | 63 | 3.41 | 0.11 | 3.0 | 0.13 | 3.7 | 0.09 | 2.5 | 0.29 | 8.5 | 0.35 | 10.1 |
| P6 | 63 | 4.25 | 0.14 | 3.3 | 0.21 | 5.0 | 0.14 | 3.2 | 0.43 | 10.1 | 0.52 | 12.2 |
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
් 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.
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 19 : MONOLISA™ Anti-HAV IgM EIA Control Reproducibility summary by Operator by Signal to Cutoff (S/CO).
| Samples | N | Mean | Within Run1 | Between Day2 | Between Operator3 | Total4 | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||
| Negative Control | 27 | 0.06 | 0.02 | 24.2 | 0.02 | 23.3 | 05 | 0 | 0.02 | N/A |
| Positive Control | 27 | 1.91 | 0.08 | 4.1 | 0.02 | 0.9 | 05 | 0 | 0.08 | 4.17 |
1 Within Run: variability of the assay performance from replicate to replicate
2 Between Day: variability of the assay performance from Day to Day
3 Between Operator: variability of the assay performance from Operator to Operator
4 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.
20
Image /page/20/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 3 2007
Manuela Kaul RA-Manager Bio-Rad France 3, Boulevard Raymond Poincaré 92430 Marnes-la-Coquette, France
Re: K063319 Trade/Device Name: MONOLISA™ Anti-HAV IgM 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, 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 (OS) regulation (21 CFR Part 820).
21
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,
Salgang
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
22
INDICATIONS FOR USE STATEMENT
510(k) Number : K 063319
Device Name: MONOLISA™ Anti-HAV IgM EIA
Indications for Use:
The MONOLISA™ Anti-HAV IgM EIA is an in vitro enzyme immunoassay kit intended for use in the qualitative detection of IgM antibodies to Hepatitis A virus (anti-HAV IgM) in human (adult and pediatric) serum or plasma (EDTA, Heparin, Citrate, ACD). This assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute Hearttis. Assay results, in conjunction with other serological or clinical information, may be used for the laboratory diagnosis of individuals with acute or recent Hepatitis A.
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)
fall an
Division sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
51010