The Copalis™ CMV Total Antibody Assay is used for the qualitative detection of total antibodies (IgG and IgM) to cytomegalovirus in men and women of child-bearing age. The presence of antibodies in these populations is indicative of recent or prior infection. These assays are not intended for screening of blood or plasma donors. The Copalis™ TORC Total Antibody Assay and the Copalis™ CMV Total Antibody Assay can be used in both the clinical and physician office laboratories. These assays can also be used to determine the CMV immune status of transplant donors and recipients.

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® CMV Total Antibody Assay is based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. Sized latex microparticles coated with inactivated CMV antigens aggregate in the presence of antibodies to CMV. 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® CMV Total Antibody Assay detects the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor proficiency.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Copalis® CMV Total Antibody Assay:

Acceptance Criteria and Reported Device Performance

Criteria	Reported Device Performance
Relative Sensitivity	100% in transplant donor population
	100% in transplant recipient population
Relative Specificity	93.7% in transplant donor population
	100% in transplant recipient population
Agreement	96.7% in transplant donor population (initial testing)
	98.4% in transplant donor population (after retest/concordance)
	100% in transplant recipient population

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: A total of 205 serum samples.
- Data Provenance: The samples included both transplant donors and recipients, tested at 2 hospital laboratories. The text does not specify the country of origin, but it implies a clinical setting. The study is retrospective as it involves testing existing serum samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that the ground truth was established by comparing the Copalis® CMV Total Antibody Assay to two predicate devices: the Abbott CMV Total AB EIA and the Becton Dickinson CMVscan. It does not mention individual experts or their qualifications for establishing the ground truth beyond the performance of these predicate devices. Therefore, the "experts" in this context are the established predicate assays.
Adjudication method for the test set:
- The document mentions "initial testing" and then "retest" for some discrepant results in transplant donors. Specifically, it states, "Two of the four false positive results observed on initial testing of transplant donors by the Copalis® system were concordant positive on retest." This suggests a form of adjudication by retesting or confirmation for discrepant results, but not a panel-based expert adjudication method like 2+1 or 3+1.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This was not an MRMC comparative effectiveness study involving human readers and AI assistance. The device is an immunoassay for detecting antibodies, not an AI-powered diagnostic imaging or interpretation tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this study is inherently a standalone performance evaluation of the immunoassay device itself. The result (presence or absence of antibodies) is generated by the assay system without direct human interpretation of a complex output, beyond reading the result provided by the system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by comparison to established predicate devices (Abbott CMV Total AB EIA and Becton Dickinson CMVscan). This is a common method for new diagnostic assays, where accepted, legally marketed assays serve as the reference standard.
The sample size for the training set:
- The document does not mention a training set. This is typical for traditional immunoassay development, which relies on biochemical principles and calibration rather than machine learning models that require a separate training phase.
How the ground truth for the training set was established:
- Not applicable, as no training set is mentioned or implied for this type of immunoassay device.

Summary

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K982027

NOV 25 1998

November 23, 1998

510(k) Summary

SUBMITTED BY:

Judith J. Smith DiaSorin Inc. 9175 Guilford Rd. Suite 100 Columbia, MD 21046

NAME OF DEVICES: Trade Name:

Common Names/Descriptions:

Copalis® CMV Total Antibody Assay ・ . . .

Immunoassay for the Detection of Total Antibodies to Cytomegalovirus Cytomegalovirus serological reagents

Classification Names:

PREDICATE DEVICES:

Copalis® CMV Total Antibody Assay, Abbott CMV Total AB EIA, Becton Dickinson CMVscan

DEVICE DESCRIPTION:

INTENDED USE: (NOTE: This is an exerpt of the Intended Use which appears in the package insert and deals specifically with CMV). The Copalis® CMV Total Antibody Assay uses Coupled Particle Light Scattering (Copalis TM) technology in a microparticle agglutination-based immunoassay for the qualitative detection of total antibodies (IgG and IgM) to 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. 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. The assay can also be used to determine the CMV immune status of transplant donors and recipients. Assay results from immunosuppressed individuals must be interpreted with caution since their antibody levels may be affected by this condition. 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,

The Copalis® CMV Total Antibody Assay is based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. Sized latex microparticles coated with inactivated

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510(k) Summary (cont.)

CMV antigens aggregate in the presence of antibodies to CMV. 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® CMV 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 2 hospital laboratories. The Copalis® CMV Total Antibody Assay was compared to the Abbott CMV Total AB EIA and the Becton Dickinson CMVscan.

A total of 205 serum samples were tested. The samples included both transplant donors and recipients. In initial testing, relative sensitivity of the CMV assay was 100% in both the transplant donor and recipient population. The relative specificity was 100% in the transplant recipient population and 93.7% in the donor population. Agreement was 100% and 96.7% in the transplant recipient and donor populations, respectively. Two of the four false positive results observed on initial testing of transplant donors by the Copalis® system were concordant positive on retest. The resulting agreement was 121/123 (98.4%).

P. 03

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that resemble a person with arms outstretched. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.

NOV 2 5 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Judith J. Smith Corporate Director Worldwide Regulatory Affairs and Quality Systems DiaSorin Inc. 9175 Guilford Rd., Suite 100 Columbia, MD 21046

Re: K982027

Trade Name: Modification to Copalis CMV Total Antibody Assay Regulatory Class: II Product Code: LFZ Dated: September 11, 1998 Received: September 14, 1998

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Not known
Copalis™ TORC Total Antibody Assay, Copalis CMV Total Device Name: Antibody Assay:

Indications For Use: The Copalis™ TORC Total Antibody Assay is used for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus in men and women of child-bearing age. The Copalis™ CMV Total Antibody Assay is used for the qualitative detection of total antibodies (IgG and IgM) to cytomegalovirus in men and women of child-bearing age. The presence of antibodies in these populations is indicative of recent or prior infection. These assays are not intended for screening of blood or plasma donors. The Copalis™ TORC Total Antibody Assay and the Copalis™ CMV Total Antibody Assay can be used in both the clinical and physician office laboratories. These assays can also be used to determine the CMV immune status of transplant donors and recipients.

Woody Dubois

ision of Clinical Laboratory Devices 510(k) Number

PRESCRIPTION USE X

Regulation Number and Section

§ 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).