INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY

K955361 · Incstar Corp. · LFZ · Jul 22, 1996 · Microbiology

Device Facts

• Record ID: K955361
• Device Name: INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
• Applicant: Incstar Corp.
• Product Code: LFZ · Microbiology
• Decision Date: Jul 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3175
• Device Class: Class 2

Intended Use

The INCSTAR CMV IgG ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to cytomegalovirus in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgG ELISA test is of value in the determination of immunological response to infection with CMV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection, reactivated infection, or reinfection with cytomegalovirus.

Device Story

In vitro diagnostic ELISA kit; detects human serum IgG antibodies to cytomegalovirus (CMV). Principle: indirect ELISA; polystyrene microtiter wells coated with purified CMV antigen; patient serum incubation; capture of CMV antibodies; horseradish peroxidase-labeled anti-human IgG conjugate addition; tetramethylbenzidine chromogen reaction. Output: color development measured via 450 nm absorbance; proportional to IgG concentration. Used in clinical laboratories; operated by trained laboratory personnel. Results aid clinicians in diagnosing primary, reactivated, or reinfection with CMV by evaluating paired acute/convalescent sera for seroconversion or antibody titer rise.

Clinical Evidence

Clinical study compared INCSTAR CMV IgG ELISA to GULL CMV IgG ELISA using 308 serum samples from 296 individuals (healthy, immunocompromised, transplant, and other illness populations). Results showed relative sensitivity 99-100%, relative specificity 96-99%, and overall agreement 90-100% (95% CI). Discrepant analysis using a third commercial ELISA confirmed the INCSTAR result for the single sample discordant with the predicate. Analytical studies included prevalence, cross-reactivity, interference, linearity, and precision.

Technological Characteristics

Indirect ELISA; polystyrene microtiter wells coated with purified CMV antigen; horseradish peroxidase-labeled anti-human IgG conjugate; tetramethylbenzidine chromogen; 450 nm absorbance measurement. In vitro diagnostic reagent kit.

Indications for Use

Indicated for qualitative/semi-quantitative detection of IgG antibodies to cytomegalovirus in human serum to determine immunological response to CMV infection. Aids diagnosis of primary, reactivated, or reinfection in populations including healthy donors, immunocompromised hosts, and transplant patients.

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

• GULL CMV IgG ELISA test (K915892)

Submission Summary (Full Text)

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K9553601
JUL 22 1996

# I. SUMMARY OF SAFETY AND EFFECTIVENESS

**DEVICE NAME:** INCSTAR CMV IgG ELISA Kit

**CLASSIFICATION:** Cytomegalovirus serological reagents
21 CFR 866.3175
Class II (Performance Standards)

**APPLICANT:** INCSTAR Corporation
1990 Industrial Boulevard
Stillwater, Minnesota 55082-0285

## INTENDED USE:

The INCSTAR CMV IgG ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to cytomegalovirus in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgG ELISA test is of value in the determination of immunological response to infection with CMV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection, reactivated infection, or reinfection with cytomegalovirus.

## DEVICE DESCRIPTION:

The INCSTAR CMV IgG ELISA test kit utilizes the enzyme-linked immunosorbant assay (ELISA) technique for the detection of cytomegalovirus IgG antibodies. Polystyrene microtiter wells are coated with purified CMV antigen. Diluted patient serum is incubated with purified CMV antigen bound to the solid surface of a microtiter well. The CMV antibodies that are present in the patient’s serum will be captured by the solid phase. After washing, these complexes bind with horseradish peroxidase labeled antihuman IgG which react with the addition of chromogen (tetramethylbenzidine), resulting in color development. The absorbance of the solution, measured at 450 nm, is directly

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# I. SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

proportional to the concentration of IgG antibodies to CMV antigen present in the reaction solution.

## SAFETY AND EFFECTIVENESS:

The INCSTAR CMV IgG ELISA Kit is substantially equivalent (SE) to the GULL CMV IgG ELISA test, 510(k) No. K915892, which has been cleared by the FDA and is currently in U.S. commercial distribution.

In clinical performance studies, 308 serum samples represented by 296 individuals were tested using the INCSTAR CMV IgG ELISA Kit and results were compared to those results generated from the GULL CMV IgG ELISA Test. The samples utilized represent a mixed population of healthy donors, immunocompromised hosts, transplant patients, and patients having various other illnesses. Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated a relative sensitivity of 99% to 100% and a relative specificity of 96% to 99%. In addition, the assay displayed an overall agreement of 90% to 100%.

Further resolution of discrepant results by a commercial CMV IgG ELISA demonstrated that of the 1 sample positive by the INCSTAR CMV IgG assay but negative by the Gull ELISA kit, 1 was positive by the resolving ELISA assay.

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