(201 days)
Becton Dickinson and Co. CMVscan Test
Becton Dickinson and Co. CMVscan Test
No
The description focuses on a traditional immunoassay technology (Coupled Particle Light Scattering) and does not mention any AI or ML components in the detection or analysis process.
No.
This device is an in vitro diagnostic (IVD) device used for the qualitative and semi-quantitative detection of antibodies to CMV in human serum, which is used for diagnostic purposes, not for treating a disease or condition.
Yes.
This device detects antibodies to cytomegalovirus (CMV) in human serum, with the stated purpose of indicating current or prior infection, and evaluating seroconversion or a significant increase in antibody level as evidence of recent infection, which are clearly diagnostic applications.
No
The device description clearly outlines a physical immunoassay using latex particles and light scattering detection, indicating it is a hardware-based system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative and semi-quantitative detection of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum". This involves testing a sample taken from the human body in vitro (outside the body) to provide information about a physiological state (presence of CMV antibodies).
- Device Description: The description details a laboratory-based immunoassay using particle agglutination and light scattering measurements to detect antibodies in a sample. This is a typical method used in IVD devices.
- Performance Studies: The performance studies involve testing patient serum samples and comparing the results to a predicate device (another IVD). This type of clinical validation is characteristic of IVD devices.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissues, to detect diseases, conditions, or infections. The description and intended use of the CopalisTM CMV Total Antibody Assay clearly fit this definition.
N/A
Intended Use / Indications for Use
The CopalisTM CMV Total Antibody Assay uses Coupled Particle Light Scattering (Copalis™) technology in a microparticle agglutinationbased immunoassay for the qualitative and semi-quantitative detection of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum using the CopalisTM One Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of this assay on a single serum specimen are used to indicate presence of antibody to CMV. When evaluating properly paired sera, the results of this assay are used to demonstrate seroconversion or a significant increase in antibody level as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results). This assay has not been FDA cleared or approved for the screening of blood or plasma donors.
Product codes
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Device Description
Coupled Particle Light Scattering (Copalis) technology provides a rapid method for the measurement of antibodies to specific viral or bacterial pathogens.
The Copalis CMV Total Antibody Assay is based on the principle of antibodydependent particle aggregation as detected by measurement of changes in light scattering. Latex particles coated with inactivated CMV antigens aggregate in the presence of antibodies to CMV. After 10 minutes of agitation, the level of aggregation is determined by measurement of the number of reacted and unreacted particles as they flow past a detector. The number of reacted particles is related to the level of CMV antibodies present in the test specimen. Without prior infection, antibody levels are absent or low. After infection, antibody levels rise and usually remain stable (but declining in titer) for years. Reactivity is assessed by the level of aggregation relative to a cutoff value. The Copalis CMV Assay detects the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor proficiency.
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
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Intended User / Care Setting
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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
Clinical Comparison: Six hundred eighty-nine (689) patient sera samples representing the mid-Atlantic and Gulf Coast regions of the U.S. were tested at 2 clinical laboratories and at Sienna Biotech Inc. In the study, the Copalis CMV Total Antibody Assay was compared to the Becton Dickinson and Co. CMVscan Test. Combined site relative sensitivity and specificity were 97.6% and 97.8%, respectively; combined site relative agreement was 97.7%.
Reproducibility: Reproducibility studies were performed at the 3 sites using one lot of TORC tests. Assay reproducibility was determined by testing four (4) samples across a range of reactivity. Five (5) runs of six (6) replicates of each sample were tested over three days.
Low Positive Control Total Precision: During the clinical trials, the Low Positive Control which is near the assay cutoff was assayed with each tray.
Reproducibility of the conversion coefficient: also evaluated at the 3 trial sites. Thirty sets of a simulated acute and convalescent pair were analyzed over several days at each site. Reproducibility was expressed as the percent of those sets which met the conversion coefficient criterion for significant rise in antibody level. Of the 30 sets per site, 30, 19 and 29 sets met the criterion of > 50%, representing 100%, 63% and 97% agreement for sites 1. 2 and 3. respectively.
CDC CMV Serum Panel: The following information is from a serum panel obtained from the CDC and tested by Sienna Biotech, Inc. The panel consists of 66% positive and 34% negative samples. The Copalis CMV Total Antibody Assay demonstrated 100% total agreement with the CDC results.
Interfering Substances: Testing was conducted at Sienna Biotech. Inc. to demonstrate that rheumatoid factor (RF) and antinuclear antibodies (ANA) do not interfere with the performance of the assay. In addition, patient samples containing antibodies to HSV, EBV, VZV, and rubella were tested. None of these factors or antibodies interfered with the Copalis CMV assay results.
Key Metrics
Combined site relative sensitivity and specificity were 97.6% and 97.8%, respectively; combined site relative agreement was 97.7%.
Predicate Device(s)
Becton Dickinson and Co. CMVscan Test
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).
0
VII. SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.
| DATE OF SUMMARY PREPARATION: | June 26, 1996 |
|---|---|
| MANUFACTURER: | Sienna Biotech, Inc. |
| 9115 Guilford Rd. | |
| Columbia, MD 21046-1893 | |
| 510(k) CONTACT PERSON: | Judith J. Smith |
| Director, Regulatory Affairs and | |
| Quality Management | |
| (301) 497-0007 x256 | |
| NAME OF DEVICE: | Copalis™ CMV Total Antibody |
| Assay | |
| COMMON NAME: | Immunoassay for the detection of |
| total antibody to CMV | |
| PREDICATE DEVICE: | Becton Dickinson and Co. |
| CMVscan Test |
DEVICE DESCRIPTION:
Intended Use: The CopalisTM CMV Total Antibody Assay uses Coupled Particle Light Scattering (Copalis™) technology in a microparticle agglutinationbased immunoassay for the qualitative and semi-quantitative detection of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum using the CopalisTM One Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of this assay on a single serum specimen are used to indicate presence of antibody to CMV. When evaluating properly paired sera, the results of this assay are used to demonstrate seroconversion or a significant increase in antibody level as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results). This assay has not been FDA cleared or approved for the screening of blood or plasma donors.
1
Kit Description: Coupled Particle Light Scattering (Copalis) technology provides a rapid method for the measurement of antibodies to specific viral or bacterial pathogens.
The Copalis CMV Total Antibody Assay is based on the principle of antibodydependent particle aggregation as detected by measurement of changes in light scattering. Latex particles coated with inactivated CMV antigens aggregate in the presence of antibodies to CMV. After 10 minutes of agitation, the level of aggregation is determined by measurement of the number of reacted and unreacted particles as they flow past a detector. The number of reacted particles is related to the level of CMV antibodies present in the test specimen. Without prior infection, antibody levels are absent or low. After infection, antibody levels rise and usually remain stable (but declining in titer) for years. Reactivity is assessed by the level of aggregation relative to a cutoff value. The Copalis CMV Assay detects the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor proficiency.
PERFORMANCE DATA:
Clinical Comparison: Six hundred eighty-nine (689) patient sera samples representing the mid-Atlantic and Gulf Coast regions of the U.S. were tested at 2 clinical laboratories and at Sienna Biotech Inc. In the study, the Copalis CMV Total Antibody Assay was compared to the Becton Dickinson and Co. CMVscan Test. Combined site relative sensitivity and specificity were 97.6% and 97.8%, respectively; combined site relative agreement was 97.7%.
Reproducibility: Reproducibility studies were performed at the 3 sites using one lot of TORC tests. Assay reproducibility was determined by testing four (4) samples across a range of reactivity. Five (5) runs of six (6) replicates of each sample were tested over three days. Results are presented below by clinical trial site:
| Site #1 | Site #2 | Site #3 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Level | Mean | ||||||||
| (CTR) | Within | ||||||||
| Assay | |||||||||
| %CV | Between | ||||||||
| Assay | |||||||||
| %CV | Mean | ||||||||
| (CTR) | Within | ||||||||
| Assay | |||||||||
| %CV | Between | ||||||||
| Assay | |||||||||
| %CV | Mean | ||||||||
| (CTR) | Within | ||||||||
| Assay | |||||||||
| %CV | Between | ||||||||
| Assay | |||||||||
| %CV | |||||||||
| RP1 | 100 | 2.2 | 0.0 | 100 | 2.0 | 0.6 | 101 | 1.6 | 0.4 |
| RP2 | 114 | 2.8 | 0.0 | 124 | 3.0 | 1.5 | 128 | 4.5 | 1.0 |
| RP3 | 133 | 3.5 | 0.0 | 157 | 4.4 | 0.8 | 161 | 5.1 | 3.9 |
| RP4 | 174 | 5.3 | 1.7 | 210 | 6.3 | 2.0 | 222 | 8.8 | 3.2 |
2
During the clinical trials, the Low Positive Control which is near the assay cutoff was assayed with each tray. Results are summarized below:
| Site | Mean
(CTR) | S.D. | %CV | Min | Max |
|------|---------------|------|-----|-----|-----|
| #1 | 120 | 5.3 | 4.4 | 113 | 136 |
| #2 | 119 | 4.9 | 4.1 | 111 | 134 |
| #3 | 125 | 5.0 | 4.0 | 114 | 140 |
Low Positive Control Total Precision
Reproducibility of the conversion coefficient was also evaluated at the 3 trial sites. Thirty sets of a simulated acute and convalescent pair were analyzed over several days at each site. Reproducibility was expressed as the percent of those sets which met the conversion coefficient criterion for significant rise in antibody level. Of the 30 sets per site, 30, 19 and 29 sets met the criterion of > 50%, representing 100%, 63% and 97% agreement for sites 1. 2 and 3. respectively.
CDC CMV Serum Panel: The following information is from a serum panel obtained from the CDC and tested by Sienna Biotech, Inc. The results are presented as a means to convey further information of the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.
The panel consists of 66% positive and 34% negative samples. The Copalis CMV Total Antibody Assay demonstrated 100% total agreement with the CDC results.
Interfering Substances: Testing was conducted at Sienna Biotech. Inc. to demonstrate that rheumatoid factor (RF) and antinuclear antibodies (ANA) do not interfere with the performance of the assay. In addition, patient samples containing antibodies to HSV, EBV, VZV, and rubella were tested. None of these factors or antibodies interfered with the Copalis CMV assay results.