(182 days)
BioWhittaker Toxostat, Becton Dickinson And Co. Rubascan, Becton Dickinson And Co. CMVscan, Abbott IMx
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No
The device description focuses on the physical and chemical principles of the assay (light scattering, particle aggregation) and the measurement of particle sizes and counts. There is no mention of AI or ML in the description, performance studies, or key metrics. The analysis of results is based on comparing aggregation levels to a cutoff value, which is a standard immunoassay method, not indicative of AI/ML.
No
This device is an immunoassay system designed for the qualitative detection of antibodies to specific pathogens, which is a diagnostic purpose, not a therapeutic one.
Yes
This device is designed for the "qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and/or cytomegalovirus (CMV) in human serum." The presence of these antibodies "is indicative of current or prior infection with the suspected organism" and the results are "used to determine the patient's immune status for rubella and to determine the patient's immunological experience for Toxoplasma gondii and CMV." This clearly indicates its use in identifying a medical condition or risk, which falls under the definition of a diagnostic device.
No
The device description explicitly mentions "Sized latex microparticles coated with inactivated Toxoplasma gondii, rubella and CMV antigens" and describes a "unique measuring system" that involves "measurement of changes in light scattering" and "discrimination of particle sizes" as they "flow past a detector." This indicates the device includes physical components beyond just 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 assays are for the "qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and/or cytomegalovirus (CMV) in human serum". This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a person's health status (presence of antibodies indicating infection or immunity).
- Device Description: The description details a laboratory-based assay using microparticle agglutination and light scattering technology to analyze the serum sample. This is a typical description of an in vitro diagnostic test.
- Performance Studies: The document describes clinical trials and comparisons with other assays, which are standard procedures for evaluating the performance of IVD devices.
- Predicate Devices: The mention of predicate devices like BioWhittaker ToxoStat, Becton Dickinson And Co. Rubascan and CMVscan, and Abbott IMx, which are known IVD assays, further confirms the nature of this device.
The entire context of the document describes a test performed on a biological sample outside the body to diagnose or provide information about a disease or condition, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Copalis™ TORC, Toxo, Rubella, and CMV Total Antibody Assays use Coupled Particle Light Scattering (Copalis) technology in microparticle agglutination-based immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and/or cytomegalovirus (CMV) in human serum using the Copalis™ I Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of these assays on a single serum specimen are used to determine the patient's immune status for rubella and to determine the patient's immunological experience for Toxoplasma gondii and CMV. When evaluating properly paired sera, the results of these assays are used to demonstrate seroconversion as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results).
The assay will also be offered as separate microparticle immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus (CMV) in human serum using the Copalis™ One Immunoassay System. The intended use of the individual assays will be specific to the individual antibodies detected but, other than that, will remain the same as the combination assay.
Product codes (comma separated list FDA assigned to the subject device)
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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 protozoal pathogens.
The Copalis™ TORC, Toxo, Rubella, and CMV Total Antibody Assays are based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. Due to the unique measuring system, a sample can be tested for antibodies to Toxoplasma gondii, rubella and CMV using a single TORC reagent and obtain results for the individual antibodies. Sized latex microparticles coated with inactivated Toxoplasma gondii, rubella and CMV antigens aggregate in the presence of antibodies to these infectious agents. After 10 minutes of agitation, the levels of aggregation are determined by discrimination of particle sizes (for the TORC assay) and measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation per particle size relative to a cutoff value. The Copalis TORC and individual Total Antibody Assays detect the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor system performance.
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
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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
A total of 769 serum samples were tested, 20% of which were fresh samples.
Clinical trials were conducted at 3 sites (2 clinical laboratories and Sienna Biotech laboratory) to evaluate the performance of the Copalis TORC, Toxo, Rubella, and CMV Total Antibody Assays in detecting antibodies to Toxoplasma gondii, rubella and CMV on the modified Copalis One Immunoassay System. The assay performance was compared to the BioWhittaker ToxoStat (ToxoStat) and the Becton Dickinson and Co. Rubascan (Rubascan) and CMVscan (CMVscan) assays.
CDC SERUM PANELS: The following information is from Rubella and CMV Serum Panels 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 masked, characterized serum panels. This does not imply an endorsement of the assay by the CDC.
The Rubella Serum Panel consists of 82% positive and 18% negative samples.
The CMV Serum Panel consists of 66% positive and 34% negative samples.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison: A comparison study was performed of patient specimens and controls using the Copalis TORC Total Antibody Assay and the Copalis individual assays. Analyses of the data by One Way Analysis of Variance showed that the differences in mean values between the component of the TORC assay and the corresponding individual assay are not great enough to exclude the possibility that the difference is due to random sampling variability: there is not a statistically significant difference (p = 0.849).
In addition, a reproducibility study was conducted to compare the components of the Copalis TORC Total Antibody Assay and the Copalis individual assays. The difference in mean CTRs and %CVs of the component of the TORC assay and the individual assay were not clinically significant. Therefore, it can be concluded that the clinical performance of the TORC and individual assays are equivalent.
Clinical trials were conducted at 3 sites (2 clinical laboratories and Sienna Biotech laboratory) to evaluate the performance of the Copalis TORC, Toxo, Rubella, and CMV Total Antibody Assays in detecting antibodies to Toxoplasma gondii, rubella and CMV on the modified Copalis One Immunoassay System. The assay performance was compared to the BioWhittaker ToxoStat (ToxoStat) and the Becton Dickinson and Co. Rubascan (Rubascan) and CMVscan (CMVscan) assays. A total of 769 serum samples were tested, 20% of which were fresh samples.
Reproducibility: Reproducibility studies were performed at the 3 sites using one lot of TORC tests. Assay component reproducibility was determined by testing 4 samples - 1 negative, 1 low positive (near the components' cutoffs) and 2 high positive (near the upper limit of the components' ranges). Samples were tested in triplicate twice a day for 5 days.
During the clinical trials, the Negative and Low Positive Controls were assayed each day of use at each site for the length of the trial.
Lot-to-lot reproducibility was established using 3 test cup lots of Copalis Rubella Total Antibody Assay.
CDC SERUM PANELS: The Copalis TORC Total Antibody Assay demonstrated 100% total agreement with the CDC rubella antibody results. The Copalis TORC Total Antibody Assay demonstrated 100% total agreement with the CDC CMV antibody results.
WHO AND CDC REFERENCE STANDARD TESTING: The WHO 3rd International Standard for Toxoplasma gondii (1000 IU/mL) and rubella (1700 IU/mL) and the CDC Rubella Standard (21 IU/mL) were tested on the Copalis TORC Total Antibody Assay. Each was diluted and tested in replicates of 5 to establish the quantitative sensitivity of the assay components' cutoffs and the reproducibility at those cutoffs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity (95% Confidence Interval):
Toxoplasma gondii Antibody: 95.4% (92.0 - 97.6%)
Rubella Antibody: 95.0% (92.9 - 96.5%)
CMV Antibody: 93.0% (90.3 - 95.2%)
Relative Specificity (95% Confidence Interval):
Toxoplasma gondii Antibody: 93.9% (91.5 - 95.8%)
Rubella Antibody: 91.7% (87.6 - 94.8%)
CMV Antibody: 97.1% (94.6 - 98.6%)
Initial Agreement:
Toxoplasma gondii Antibody: 94.3%
Rubella Antibody: 93.9%
CMV Antibody: 94.7%
Agreement Following Resolution of Discordants:
Toxoplasma gondii Antibody: 97.9%
Rubella Antibody: 97.8%
CMV Antibody: 99.7%
Reproducibility (%CV):
Toxoplasma gondii Antibody:
RP1: Within Run 1.8%, Total 2.0%
RP2: Within Run 3.0%, Total 4.4%
RP3: Within Run 4.1%, Total 5.9%
RP4: Within Run 4.7%, Total 7.3%
Rubella Antibody:
RP1: Within Run 1.9%, Total 2.0%
RP2: Within Run 2.1%, Total 2.7%
RP3: Within Run 3.0%, Total 5.2%
RP4: Within Run 3.6%, Total 7.3%
CMV Antibody:
RP1: Within Run 2.1%, Total 2.8%
RP2: Within Run 3.9%, Total 4.6%
RP3: Within Run 4.5%, Total 5.8%
RP4: Within Run 4.8%, Total 7.7%
Controls Total Precision (%CV):
Toxoplasma gondii Negative: 2.6%
Toxoplasma gondii Low Positive: 4.5%
Rubella Negative: 3.1%
Rubella Low Positive: 4.5%
CMV Negative: 2.8%
CMV Low Positive: 4.1%
Lot-to-Lot Reproducibility - Antibody to Rubella (%CV):
Negative: Lot #1 1.3%, Lot #2 3.0%, Lot #3 1.5%
Low Positive: Lot #1 4.7%, Lot #2 2.9%, Lot #3 2.4%
Mid Positive: Lot #1 7.6%, Lot #2 6.7%, Lot #3 4.8%
High Positive: Lot #1 5.1%, Lot #2 2.9%, Lot #3 7.1%
WHO and CDC Reference Standard Testing Results (%CV):
WHO 3rd I.S. Toxoplasma gondii (1000 IU/mL) 25 IU/mL Dilution: 0.9%
WHO 3rd I.S. Rubella (1700 IU/mL) 10 IU/mL Dilution: 2.1%
CDC Rubella (21 IU/mL) 10 IU/mL Dilution: 1.3%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BioWhittaker Toxostat, Becton Dickinson And Co. Rubascan, Becton Dickinson And Co. CMVscan, Abbott IMx
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.3510 Rubella virus serological reagents.
(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY:
Judith J. Smith Sienna Biotech, Inc. 9115 Guilford Rd. Suite 180 Columbia, MD 21046
Image /page/0/Picture/5 description: The image shows the date October 31, 1996. The text is written in a bold, sans-serif font. The letters and numbers are all black, and the background is white. The date is written in the format month, day, year.
NAME OF DEVICES:
Trade Name:
Copalis One Immunoassay System; Copalis TORC Total Antibody Assay; Copalis Toxoplasma gondii Total Antibody Assay; Copalis Rubella Total Antibody Assay Copalis CMV Total Antibody Assay
Common Names/Descriptions:
Immunoassay Analyzer; Immunoassay for the Detection of Total Antibodies to Toxoplasma gondii, Rubella and Cytomegalovirus
Classification Names:
Nephelometer for clinical use; Toxoplasma gondii serological reagents; Rubella virus serological reagents; Cytomegalovirus serological reagents
PREDICATE DEVICES:
BioWhittaker Toxostat; Becton Dickinson And Co. Rubascan and CMVscan; Abbott IMx
DEVICE DESCRIPTION:
INTENDED USE: The Copalis™ TORC, Toxo, Rubella, and CMV Total Antibody Assays use Coupled Particle Light Scattering (Copalis) technology in microparticle agglutination-based immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and/or cytomegalovirus (CMV) in human serum using the Copalis™ I Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of these assays on a single serum specimen are used to determine the patient's immune status for rubella and to determine the patient's immunological experience for Toxoplasma gondii and CMV. When evaluating properly paired sera, the results of these assays are used to demonstrate seroconversion as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results).
1
These assays has not been FDA cleared or approved for the screening of blood or plasma donors.
The assay will also be offered as separate microparticle immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus (CMV) in human serum using the Copalis™ One Immunoassay System. The intended use of the individual assays will be specific to the individual antibodies detected but, other than that, will remain the same as the combination assay.
KIT DESCRIPTION: Coupled Particle Light Scattering (Copalis) technology provides a rapid method for the measurement of antibodies to specific viral or protozoal pathogens.
The Copalis™ TORC, Toxo, Rubella, and CMV Total Antibody Assays are based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. Due to the unique measuring system, a sample can be tested for antibodies to Toxoplasma gondii, rubella and CMV using a single TORC reagent and obtain results for the individual antibodies. Sized latex microparticles coated with inactivated Toxoplasma gondii, rubella and CMV antigens aggregate in the presence of antibodies to these infectious agents. After 10 minutes of agitation, the levels of aggregation are determined by discrimination of particle sizes (for the TORC assay) and measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation per particle size relative to a cutoff value. The Copalis TORC and individual Total Antibody Assays detect the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor system performance.
PERFORMANCE DATA:
Comparison: A comparison study was performed of patient specimens and controls using the Copalis TORC Total Antibody Assay and the Copalis individual assays. Analyses of the data by One Way Analysis of Variance showed that the differences in mean values between the component of the TORC assay and the corresponding individual assay are not great enough to exclude the possibility that the difference is due to random sampling variability: there is not a statistically significant difference (p = 0.849).
In addition, a reproducibility study was conducted to compare the components of the Copalis TORC Total Antibody Assay and the Copalis individual assays. The difference in mean CTRs and %CVs of the component of the TORC assay and the individual assay were not clinically significant. Therefore, it can be concluded that the clinical performance of the TORC and individual assays are equivalent.
Clinical trials were conducted at 3 sites (2 clinical laboratories and Sienna Biotech laboratory) to evaluate the performance of the Copalis TORC, Toxo,
2
Rubella, and CMV Total Antibody Assays in detecting antibodies to Toxoplasma gondii, rubella and CMV on the modified Copalis One Immunoassay System. The assay performance was compared to the BioWhittaker ToxoStat (ToxoStat) and the Becton Dickinson and Co. Rubascan (Rubascan) and CMVscan (CMVscan) assays.
A total of 769 serum samples were tested, 20% of which were fresh samples. Combined site testing results for each component of the assay are presented in Table A.
Table A Comparison of the Copalis™ TORC Total Antibody Assay with Commercially Available Assays -Combined Site Results
| Toxoplasma gondii Antibody | Rubella Antibody | CMV Antibody | |
|---|---|---|---|
| Relative Sensitivity | |||
| (95% Confidence Interval) | 95.4% | 95.0% | 93.0% |
| (92.0 - 97.6%) | (92.9 - 96.5%) | (90.3 - 95.2%) | |
| Relative Specificity | |||
| (95% Confidence Interval) | 93.9% | 91.7% | 97.1% |
| (91.5 - 95.8%) | (87.6 - 94.8%) | (94.6 - 98.6%) | |
| Initial Agreement | 94.3% | 93.9% | 94.7% |
| Agreement Following | |||
| Resolution of Discordants | 97.9% | 97.8% | 99.7% |
Reproducibility:
Reproducibility studies were performed at the 3 sites using one lot of TORC tests. Assay component reproducibility was determined by testing 4 samples - 1 negative, 1 low positive (near the components' cutoffs) and 2 high positive (near the upper limit of the components' ranges). Samples were tested in triplicate twice a day for 5 days. The results are summarized in Table B.
Table B Reproducibility Results For Copalis Torc Total Antibody Assay - Combined Sites
| SAMPLE | ANTIBODY TO TOXOPLASMA
GONDII | | | ANTIBODY TO RUBELLA | | | ANTIBODY TO CMV | | |
|-----------------|----------------------------------|----------------------|--------------|---------------------|----------------------|--------------|-----------------|----------------------|--------------|
| | MEAN
CTR | WITHIN
RUN
%CV | TOTAL
%CV | MEAN
CTR | WITHIN
RUN
%CV | TOTAL
%CV | MEAN
CTR | WITHIN
RUN
%CV | TOTAL
%CV |
| RP1
(n = 89) | 103 | 1.8 | 2.0 | 105 | 1.9 | 2.0 | 102 | 2.1 | 2.8 |
| RP2
(n = 86) | 129 | 3.0 | 4.4 | 116 | 2.1 | 2.7 | 132 | 3.9 | 4.6 |
| RP3
(n = 86) | 157 | 4.1 | 5.9 | 128 | 3.0 | 5.2 | 166 | 4.5 | 5.8 |
| RP4
(n = 85) | 177 | 4.7 | 7.3 | 150 | 3.6 | 7.3 | 207 | 4.8 | 7.7 |
3
During the clinical trials, the Negative and Low Positive Controls were assayed each day of use at each site for the length of the trial. Results are summarized in Table C.
| Component | ||||
|---|---|---|---|---|
| Control | Toxoplasma gondii | Rubella | CMV | |
| Negative | Mean | 102 | 102 | 101 |
| % CV | 2.6 | 3.1 | 2.8 | |
| n | રૂદ | રૂદ | રૂડ્યુ | |
| Low Positive | Mean | 124 | 120 | 124 |
| % CV | 4.5 | 4.5 | 4.1 | |
| n | તે રેણ | તે રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેત-ઉત્પત્તમજૂરી તેમ જ દૂધની ડેરી | વેરૂ |
Table C Controls Total Precision
Lot-to-lot reproducibility was established using 3 test cup lots of Copalis Rubella Total Antibody Assay. A summary of the data is presented in Table D.
| Level | Lot #1 | Lot #2 | Lot #3 | |
|---|---|---|---|---|
| Negative | Mean | 100 | 100 | 102 |
| % CV | 1.3 | 3.0 | 1.5 | |
| Low Positive | Mean | 131 | 125 | 128 |
| % CV | 4.7 | 2.9 | 2.4 | |
| Mid Positive | Mean | 162 | 150 | 156 |
| % CV | 7.6 | 6.7 | 4.8 | |
| High Positive | Mean | 204 | 187 | 197 |
| % CV | 5.1 | 2.9 | 7.1 |
Table D Lot-to-Lot Reproducibility - Antibody to Rubella
CDC SERUM PANELS: The following information is from Rubella and CMV Serum Panels 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 masked, characterized serum panels. This does not imply an endorsement of the assay by the CDC.
The Rubella Serum Panel consists of 82% positive and 18% negative samples. The Copalis TORC Total Antibody Assay demonstrated 100% total agreement with the CDC rubella antibody results.
The CMV Serum Panel consists of 66% positive and 34% negative samples. The Copalis TORC Total Antibody Assay demonstrated 100% total agreement with the CDC CMV antibody results.
WHO AND CDC REFERENCE STANDARD TESTING: The WHO 30 International Standards for Toxoplasma gondii (1000 IU/mL) and rubella (1700 IU/mL) and the CDC Rubella Standard (21 IU/mL) were tested on the Copalis TORC Total Antibody Assay. Each was diluted and tested in replicates of 5 to
4
establish the quantitative sensitivity of the assay components' cutoffs and the reproducibility at those cutoffs. Results are summarized in Table E.
| WHO and CDC Reference Standard Testing Results | |||
|---|---|---|---|
| WHO 3rd I.S. Toxoplasma | |||
| gondii (1000 IU/mL) | |||
| 25 IU/mL Dilution | WHO 3rd I.S. Rubella | ||
| (1700 IU/mL) | |||
| 10 IU/mL Dilution | CDC Rubella | ||
| (21 IU/mL) | |||
| 10 IU/mL Dilution | |||
| Mean (CTR) | 116 | 117 | 116 |
| %CV | 0.9% | 2.1% | 1.3% |
| Range (CTR) | 115 - 118 | 114 - 120 | 115 - 118 |
Table E WHO and CDC Refer d Tostina Posulta