INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

K960434 · Incstar Corp. · LFZ · Oct 17, 1996 · Microbiology

Device Facts

• Record ID: K960434
• Device Name: INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
• Applicant: Incstar Corp.
• Product Code: LFZ · Microbiology
• Decision Date: Oct 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3175
• Device Class: Class 2

Intended Use

The INCSTAR CMV IgM Capture ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgM antibodies to cytomegalovirus in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active CMV infection. The evaluation of paired CMV IgM sera can also aid in determining the stage of active CMV infection.

Device Story

In vitro diagnostic ELISA kit; detects IgM antibodies to cytomegalovirus (CMV) in human serum. Principle: reverse capture ELISA; patient serum incubated in microtiter wells coated with mouse monoclonal anti-human IgM; patient IgM captured; anti-CMV monoclonal antibody conjugated to horseradish peroxidase binds to captured anti-CMV IgM; chromogen added for colorimetric detection. Absorbance measured at 450 nm; proportional to anti-CMV IgM concentration. Used in clinical laboratories by trained personnel. Results aid clinicians in diagnosing current/recent active CMV infection and staging infection via paired sera analysis.

Clinical Evidence

Clinical study of 529 serum samples from 474 individuals (healthy, immunocompromised, transplant, congenital CMV, other illnesses). Compared INCSTAR CMV IgM Capture ELISA to BioWhittaker CMV CAP-M ELISA. Results (95% CI): relative sensitivity 88-97%, relative specificity 92-97%, overall agreement 92-96%. Discrepant analysis performed using Gull CMV IgM ELISA (K903807).

Technological Characteristics

Reverse capture ELISA; microtiter well solid phase; mouse monoclonal anti-human IgM (μ chain specific) capture antibody; horseradish peroxidase-conjugated anti-CMV monoclonal antibody detection system; chromogenic substrate; 450 nm absorbance measurement.

Indications for Use

Indicated for the qualitative and/or semi-quantitative detection of IgM antibodies to cytomegalovirus in human serum to aid in the diagnosis of current or recent active CMV infection in patients, including healthy donors, immunocompromised hosts, transplant patients, and congenital CMV cases.

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

• BioWhittaker CMV CAP-M ELISA test (K896295)

Reference Devices

• Gull CMV IgM ELISA (K903807)

Submission Summary (Full Text)

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K960434

# I. SUMMARY OF SAFETY AND EFFECTIVENESS

**DEVICE NAME:** INCSTAR CMV IgM Capture ELISA Kit
**CLASSIFICATION:** Cytomegalovirus serological reagents
21 CFR 866.3175
Class II (Performance Standards)
**APPLICANT:** INCSTAR Corporation
1990 Industrial Boulevard
Stillwater, Minnesota 55082-0285
**OCT 7 1996**

## INTENDED USE:

The INCSTAR CMV IgM Capture ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgM antibodies to cytomegalovirus in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active CMV infection. The evaluation of paired CMV IgM sera can also aid in determining the stage of active CMV infection.

## DEVICE DESCRIPTION:

The INCSTAR CMV IgM Capture ELISA test kit utilizes the enzyme-linked immunosorbent assay (ELISA) based on the antibody capture technique. Diluted patient serum is incubated with mouse monoclonal antibody against human IgM (μ chain specific) bound to the solid surface of a microtiter well. Patient IgM is “captured” by the surface bound antibody. The presence of patient anti-CMV IgM antibodies are then “detected” and bound by CMV antigen which is linked to an anti-CMV monoclonal antibody conjugated to horseradish peroxidase. Bound horseradish peroxidase is reacted with chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgM to CMV antigen present in the reaction solution

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# I. SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

## SAFETY AND EFFECTIVENESS:

The INCSTAR CMV IgM Capture ELISA Kit is substantially equivalent (SE) to the BioWhittaker CMV CAP-M ELISA test, 510(k) No K896295, which has been cleared by the FDA and is currently in U.S. commercial distribution.

In clinical performance studies, 529 serum samples represented by 474 individuals were tested using the INCSTAR CMV IgM Capture ELISA Kit and results were compared to those results generated from the BioWhittaker CMV CAP-M ELISA Test. The samples utilized represent a mixed population of healthy donors, immunocompromised hosts, transplant patients, congenital CMV babies, and patients having various other illnesses. Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated a relative sensitivity of 88% to 97% and a relative specificity of 92% to 97%. In addition, the assay displayed an overall agreement of 92% to 96%.

Further resolution of discrepant results by a commercial CMV IgM ELISA method [Gull CMV IgM ELISA (510(K) No. K903807)] demonstrated that of the 21 samples positive by the INCSTAR CMV IgM Capture ELISA assay but negative by the reference ELISA assay, 17 samples contained sufficient quantities for resolution and 10 were found to be positive by the resolving ELISA method. Of the 10 samples negative by the INCSTAR CMV IgM Capture ELISA assay but positive by the reference ELISA assay, 9 samples contained sufficient quantities for resolution and 8 were found to be negative by the resolving ELISA method.

Prevalency, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR CMV IgM Capture Kit package insert.