OPUS CMV TEST SYSTEM-MODIFICATION

K963084 · Behring Diagnostics, Inc. · LFZ · Oct 9, 1996 · Microbiology

Device Facts

• Record ID: K963084
• Device Name: OPUS CMV TEST SYSTEM-MODIFICATION
• Applicant: Behring Diagnostics, Inc.
• Product Code: LFZ · Microbiology
• Decision Date: Oct 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3175
• Device Class: Class 2

Intended Use

OPUS® Anti CMV is a qualitative fluorogenic enzyme-linked immunosorbent assay (ELISA) used in the detection of total antibody to cytomegalovirus in human serum or heparin plasma to determine serological evidence of previous CMV infection. The OPUS Anti CMV assay is also intended for use to screen blood and/plasma donors to determine serological evidence of previous CMV infection. OPUS Anti CMV is intended for use with the OPUS analyzers.

Device Story

OPUS Anti-CMV is a qualitative fluorogenic ELISA for detecting total CMV antibodies in human serum or heparin plasma. The device uses a test module containing solid-phase recombinant protein A/G on glass fiber, a recombinant CMV antigen/alkaline phosphatase conjugate, and a 4-methylumbelliferyl phosphate substrate. It operates on OPUS analyzers. The assay binds CMV antibodies to the enzyme-labeled recombinant CMV antigen; the resulting reaction produces a fluorescent signal measured by the analyzer. Used in clinical laboratories and blood/plasma donor centers to determine serological evidence of previous CMV infection. Results assist healthcare providers in screening donors and assessing patient CMV serostatus.

Clinical Evidence

Bench testing and comparative correlation studies performed. Precision evaluated on OPUS Immunoassay System: intra-assay %CV 5.8-20%, inter-assay %CV 8.9-21.4%. Accuracy compared to Abbott CMV test in preselected and blood donor populations showed relative sensitivity of 96.6-97.7% and relative specificity of 100%. Interfering substances (e.g., bilirubin, triglycerides, hemoglobin, rheumatoid factor, various viral antibodies) showed no interference. Expected positive frequency ranged from 14.4% to 30.6% across different geographic donor populations.

Technological Characteristics

Qualitative fluorogenic ELISA. Components: solid-phase recombinant protein A/G on glass fiber, recombinant CMV antigen/alkaline phosphatase conjugate, 4-methylumbelliferyl phosphate substrate. Analyte: total CMV antibodies. Sample type: human serum or heparin plasma. Platform: OPUS analyzers.

Indications for Use

Indicated for the detection of total antibodies to cytomegalovirus (CMV) in human serum or heparin plasma to determine serological evidence of previous infection. Intended for use in screening blood and plasma donors.

Regulatory Classification

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.

Predicate Devices

• Abbott CMV Total AB EIA

Submission Summary (Full Text)

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K963084
OCT - 9 1996

# 510(k) Summary for OPUS Anti CMV Expanded Intended Use

1. Manufacturer Name, Address, phone number, contact name and date of preparation:

Manufacturer
Behring Diagnostics Inc.,
151 University Avenue
Westwood, MA 02090
617-320-3153
Contact name: Kathleen Dray-Lyons

date of preparation: October 2, 1996

2. Device Name/Classification:

OPUS Anti-CMV
Cytomegalovirus serological reagents

Classification number:
Class II (866-3175)

3. Identification of the legally marketed device to which the submitter claims equivalence.

Abbott CMV Total AB EIA

4. Proposed Device Description:

OPUS Anti CMV is a qualitative fluorogenic enzyme-linked immunosorbent assay (ELISA), based on liquid phase binding of CMV antibodies to enzyme labeled recombinant CMV antigen. Each test module contains a solid phase recombinant protein A/G immobilized onto glass fiber. A recombinant CMV antigen/alkaline phosphatase conjugate solution and a wash/substrate solution (4-methylumbelliferyl phosphate) are sealed in separate well within the test module.

5. Proposed Device Intended Use:

OPUS® Anti CMV is a qualitative fluorogenic enzyme-linked immunosorbent assay (ELISA) used in the detection of total antibody to cytomegalovirus in human serum or heparin plasma to determine serological evidence of previous CMV infection. The OPUS Anti CMV assay is also intended for use to screen blood and/plasma donors to determine serological evidence of previous CMV infection. OPUS Anti CMV is intended for use with the OPUS analyzers.

6. Medical device to which equivalence is claimed and comparison information:

The OPUS Anti CMV assay is substantially equivalent in intended use to the Abbott CMV Total AB EIA test system. Both products are in vitro diagnostic test systems intended for use as a qualitative measurement of Cytomegalovirus (CMV) in the blood/plasma donor population. The Abbott CMV Total AB EIA, like the proposed product, employs an enzyme-labeled conjugate for the qualitative detection of total antibody to CMV in human serum. Both are based on a two level calibrator system.

The OPUS Anti-CMV differs from the Abbott CMV Total AB EIA in that the OPUS CMV contains Omnibind™ A/G to bind human immunoglobulins whereas the Abbott CMV contains anti-human immunoglobulins. Additionally, the OPUS CMV uses a recombinant CMV antigen in its conjugate preparation whereas Abbott uses native CMV coated onto a bead.

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# 7. Proposed Device Performance characteristics:

## Precision:

Precision of the OPUS Anti-CMV test system was evaluated on the OPUS Immunoassay System. Assay precision was determined by the evaluation of reactive and nonreactive calibrator signals (assay value/cutoff) and individual clinical specimen signals.

Intra-assay precision %CV’s ranged from 5.8-20%.

Inter-assay precision %CV’s ranged from 8.9-21.4%.

## Interfering Substances:

Levels of the following do not appear to interfere with the OPUS Anti CMV assay:

| Substance | Up to: |
| --- | --- |
| total protein | 11.5 g/dL |
| triglycerides | 780 mg/dL |
| cholesterol | 450 mg/dL |
| hemoglobin | 1000 mg/dL |
| immunoglobulins | 16000 mg/dL |
| bilirubin | 25.4 mg/dL |
| Rheumatoid factor | 567 IU/mL |
| ANA | 1:640 |
| Epstein-Barr | 3.33 (signal/cutoff) |
| herpes simplex I/II | I=3.64/II=2.17 (signal/cutoff) |
| Herpes-Zoster | 2.31(signal/cutoff) |
| HBsAg | 118 (signal/cutoff) |
| Elevated IgM | 1550 (signal/cutoff) |
| Anti-HIV Positive | (western blot confirmed) |
| Anti-HCV positive | >4.505 signal over range |
| Anti-HAV positive | 26.000 (signal/cutoff) |

## Accuracy by Correlation:

Results of comparative studies using the OPUS Anti CMV assay and the Abbott CMV test in both preselected and blood donor populations ranged from a relative sensitivity of 96.6-97.7% and a relative specificity of 100% respectively.

## Expected Values:

Based on the studies performed in blood and plasma donor centers using the OPUS Anti CMV assay, the expected CMV antibody positive frequency for the population tested is 27.4% in Massachusetts, 14.4% in Florida and 30.6% in Illinois.