(48 days)
Abbott IMx Toxo IgG 2.0, Rubella IgG 2.0, CMV IgG
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No
The device description details a microparticle agglutination-based immunoassay using light scattering detection and particle size analysis. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The analysis relies on established cutoff values, not adaptive algorithms.
No.
The device is an in-vitro diagnostic assay used to detect antibodies for diagnostic purposes, not to provide therapy or treatment.
Yes
This device is used for the qualitative detection of total antibodies to Toxoplasma gondii, rubella, and cytomegalovirus (CMV) in human serum, with results used to determine immune status or recent infection, which are all diagnostic purposes.
No
The device description clearly outlines a hardware-based immunoassay system that uses microparticles, light scattering detection, and agitation. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the qualitative detection of total antibodies to Toxoplasma gondii, rubella, and cytomegalovirus (CMV) in human serum. This is a biological specimen taken from the human body.
- Device Description: The device description details a laboratory-based immunoassay using microparticle agglutination to detect antibodies in a sample.
- Performance Studies: The performance studies involve testing clinical serum samples and a proficiency panel, which are typical for evaluating the performance of an IVD.
- Predicate Devices: The listed predicate devices (Abbott IMx Toxo IgG 2.0, Abbott IMx Rubella IgG 2.0, Abbott IMx CMV IgG) are all known IVD devices for detecting antibodies to these specific pathogens.
The core function of the device is to analyze a biological sample (human serum) in vitro (outside the body) to provide information about a person's health status (presence of antibodies indicating infection or immunity). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Copalis TORC Total Antibody Assay uses Coupled Particle Light Scattering (Copalis) technology in a microparticle agglutinationbased immunoassay 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 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 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 this assay are used to demonstrate seroconversion 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 (comma separated list FDA assigned to the subject device)
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Device Description
The Copalis™ TORC Total Antibody Assay uses Coupled Particle Light Scattering (Copalis™) technology in a microparticle agglutinationbased immunoassay for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus (CMV) in human serum using the CopalisTM One Immunoassay System. The Copalis TORC Total Antibody Assay is based on the principle of antibodydependent 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 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 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 Total Antibody Assay detects the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor proficiency.
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
Physician Office Laboratory (POL)
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
Clinical Sample Testing: 250 serum samples tested at Sienna Biotech laboratory.
Physician Office Laboratory (POL) Proficiency Study: A 14-member blinded proficiency panel was tested by each operator in each of three runs. Proficiency was determined by comparison of Copalis TORC assay results for each panel member with the "expected" results as established by in-house testing on a comparator assay. Reproducibility was determined based on the 7 samples run in duplicate within each run.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Sample Testing: Clinical sample testing was conducted at Sienna Biotech laboratory to evaluate the performance of the Copalis TORC Total Antibody Assay (TORC) compared to the corresponding Abbott IMx assays. A total of 250 serum samples were tested.
Physician Office Laboratory (POL) Proficiency Study: This study was conducted at 3 POL sites with 4 operators. The study showed 100% agreement between Copalis results from all operators and expected results. Within-run and total percent coefficient of variation (%CV) were calculated for each sample.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Sample Testing:
Relative sensitivity of the Toxoplasma gondii antibody component of the assay was 91.4%; relative specificity was 98.6%.
Relative sensitivity of the rubella antibody component of the assay was 98.7%; relative specificity was 100%.
Relative sensitivity of the CMV antibody component of the assay was 94.4%; relative specificity was 100%.
Reproducibility (%CV):
Sample #1: TOXO within-run %CV 5.9, total %CV 7.7; RUBELLA within-run %CV 6.0, total %CV 8.2; CMV within-run %CV 11.9, total %CV 13.9.
Sample #2: TOXO within-run %CV 6.7, total %CV 9.0; RUBELLA within-run %CV 7.9, total %CV 7.6; CMV within-run %CV 2.4, total %CV 2.4.
Sample #3: TOXO within-run %CV 6.6, total %CV 8.0; RUBELLA within-run %CV 9.5, total %CV 8.3; CMV within-run %CV 6.5, total %CV 6.0.
Sample #4: TOXO within-run %CV 1.5, total %CV 2.3; RUBELLA within-run %CV 6.0, total %CV 7.4; CMV within-run %CV 6.3, total %CV 13.2.
Sample #5: TOXO within-run %CV 1.7, total %CV 2.3; RUBELLA within-run %CV 5.2, total %CV 5.4; CMV within-run %CV 2.1, total %CV 2.8.
Sample #6: TOXO within-run %CV 1.6, total %CV 2.4; RUBELLA within-run %CV 4.1, total %CV 6.7; CMV within-run %CV 8.2, total %CV 15.8.
Sample #7: TOXO within-run %CV 1.0, total %CV 2.5; RUBELLA within-run %CV 3.6, total %CV 7.0; CMV within-run %CV 2.2, total %CV 7.5.
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.
Abbott IMx Toxo IgG 2.0, Rubella IgG 2.0, CMV IgG
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
Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters, which appears to be a combination of letters and numbers. The sequence reads 'K970931'. The characters are written in a bold, somewhat stylized font, with thick strokes that give them a distinct and easily readable appearance. The overall impression is that of a code or identifier, possibly a serial number or reference code.
March 6, 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY:
Judith J. Smith Sienna Biotech, Inc. 9115 Guilford Rd. Suite 180 Columbia, MD 21046
NAME OF DEVICES:
Trade Name:
Common Names/Descriptions:
Copalis TORC Total Antibody Assay
APR 2 4 1997
Immunoassay for the Detection of Total Antibodies to Toxoplasma gondii, Rubella and Cytomegalovirus
Classification Names:
y
Toxoplasma gondii serological reagents; Rubella virus serological reagents; Cytomegalovirus serological reagents
PREDICATE DEVICES:
Abbott IMx Toxo IgG 2.0, Rubella IgG 2.0, CMV IgG
DEVICE DESCRIPTION:
INTENDED USE: The Copalis™ TORC Total Antibody Assay uses Coupled Particle Light Scattering (Copalis™) technology in a microparticle agglutinationbased immunoassay for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and 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 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 this assay are used to demonstrate seroconversion 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.
KIT DESCRIPTION: Coupled Particle Light Scattering (Copalis) technology provides a rapid method for the measurement of antibodies to specific viral or protozoal pathogens.
1
SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)
The Copalis TORC Total Antibody Assay is based on the principle of antibodydependent 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 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 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 Total Antibody Assay detects the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor proficiency.
PERFORMANCE DATA:
Clinical Sample Testing: Clinical sample testing was conducted at Sienna Biotech laboratory to evaluate the performance of the Copalis TORC Total Antibody Assay (TORC) compared to the corresponding Abbott IMx assays.
A total of 250 serum samples were tested. In initial testing, relative sensitivity of the Toxoplasma gondii antibody component of the assay was 91.4%; relative specificity was 98.6%. Relative sensitivity of the rubella antibody component of the assay was 98.7%; relative specificity was 100%. Relative sensitivity of the CMV antibody component of the assay was 94.4%; relative specificity was 100%.
Physician Office Laboratory (POL) Proficiency Study:
A study was conducted at 3 POL sites to evaluate the proficiency and reproducibility of different operators with the Copalis TORC Total Antibody Assay (TORC). The 3 sites represented POLs ranging from small to large group practices; 4 operators participated in the study, representing high school to 4-year educational levels.
A 14-member blinded proficiency panel was tested by each operator in each of three runs. Proficiency among operators was determined by comparison of Copalis TORC assay results for each panel member with the "expected" results as established by in-house testing on a comparator assay. The study showed 100% agreement between Copalis results from all operators and expected results.
Reproducibility was determined based on the 7 samples run in duplicate within each run. Within-run and total percent coefficient of variation (%CV) were calculated among operators for each sample. See the following table for a summary of %CV ranges.
2
SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)
| SAMPLE | RANGE | TOXO | RUBELLA | CMV |
|---|---|---|---|---|
| #1 | CTR | 131 | 190 | 215 |
| WITHIN-RUN %CV | 5.9 | 6.0 | 11.9 | |
| TOTAL %CV | 7.7 | 8.2 | 13.9 | |
| #2 | CTR | 151 | 189 | 100 |
| WITHIN-RUN %CV | 6.7 | 7.9 | 2.4 | |
| TOTAL %CV | 9.0 | 7.6 | 2.4 | |
| #3 | CTR | 134 | 188 | 127 |
| WITHIN-RUN %CV | 6.6 | 9.5 | 6.5 | |
| TOTAL %CV | 8.0 | 8.3 | 6.0 | |
| #4 | CTR | 101 | 201 | 223 |
| WITHIN-RUN %CV | 1.5 | 6.0 | 6.3 | |
| TOTAL %CV | 2.3 | 7.4 | 13.2 | |
| #5 | CTR | 101 | 150 | 101 |
| WITHIN-RUN %CV | 1.7 | 5.2 | 2.1 | |
| TOTAL %CV | 2.3 | 5.4 | 2.8 | |
| #6 | CTR | 100 | 133 | 250 |
| WITHIN-RUN %CV | 1.6 | 4.1 | 8.2 | |
| TOTAL %CV | 2.4 | 6.7 | 15.8 | |
| #7 | CTR | 101 | 141 | 140 |
| WITHIN-RUN %CV | 1.0 | 3.6 | 2.2 | |
| TOTAL %CV | 2.5 | 7.0 | 7.5 |
Physician Office Laboratory Reproducibility;
Total Precision - All Sites, All Operators