INCSTAR RUBELLA IGG FAST ELISA ASSAY

K960358 · Incstar Corp. · LFX · Oct 24, 1996 · Microbiology

Device Facts

• Record ID: K960358
• Device Name: INCSTAR RUBELLA IGG FAST ELISA ASSAY
• Applicant: Incstar Corp.
• Product Code: LFX · Microbiology
• Decision Date: Oct 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

In vitro diagnostic ELISA kit; detects IgG antibodies to rubella in human serum. Process: diluted patient serum incubated in microtiter wells coated with purified rubella antigen; antigen-antibody complexes form; horseradish peroxidase-labeled anti-human IgG added; chromogen added for color development. Output: absorbance measured at 450 nm, proportional to IgG concentration. Used in clinical laboratories; results interpreted by healthcare professionals to assess rubella immune status or diagnose infection.

Clinical Evidence

Clinical study of 497 serum samples (clinical patients, newborns, screenings, pregnant women) compared subject device to predicate. Results: relative sensitivity 91-100%, relative specificity 97-100%, overall agreement 97-99% (95% CI). Discrepant analysis performed using Abbott Rubazyme EIA.

Technological Characteristics

Indirect ELISA technique; microtiter well solid phase; purified rubella antigen; horseradish peroxidase-labeled anti-human IgG conjugate; chromogen substrate; 450 nm absorbance measurement.

Indications for Use

Indicated for qualitative/semi-quantitative detection of IgG antibodies to rubella in human serum to determine immunological status or aid in diagnosis of current/recent infection via paired sera analysis. Population includes clinical patients, newborns, and pregnant women.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Rubella IgG Clin-ELISA Kit (K860145)

Reference Devices

• Abbott Rubazyme EIA (K885297)

Submission Summary (Full Text)

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K960358

OCT 24 1996

## I. SUMMARY OF SAFETY AND EFFECTIVENESS

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# I. SUMMARY OF SAFETY AND EFFECTIVENESS

**DEVICE NAME:** INCSTAR Rubella IgG “fast” ELISA Kit

**CLASSIFICATION:** Rubella virus serological reagents
Section 21 CFR 866.3510
Class III

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

**INTENDED USE:**
The INCSTAR Rubella IgG “fast” ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Rubella IgG “fast” ELISA test is of value in the determination of rubella immunological status. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of current or recent infection with rubella.

**DEVICE DESCRIPTION:**
The INCSTAR Rubella IgG “fast” ELISA test kit utilizes the ELISA technique for the detection of rubella IgG antibodies. Diluted patient serum is incubated with purified rubella antigen bound to the solid surface of a microtiter well. If IgG antibodies to rubella are present in the patient’s serum, antigen-antibody complexes are formed. These complexes bind with horseradish peroxidase labeled antihuman IgG which react with the addition of chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgG antibodies to rubella antigen present in the reaction solution.

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# I. SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

## SAFETY AND EFFECTIVENESS:

The INCSTAR Rubella IgG "fast" ELISA Kit is substantially equivalent (SE) to the Rubella IgG Clin-ELISA Kit, 510(k) No. K860145, which has been cleared by the FDA and is currently in U.S. commercial distribution.

In clinical performance studies, 497 serum samples represented by 497 individuals were tested with the INCSTAR Rubella IgG "fast" ELISA Kit and results were compared to those results generated from the Rubella IgG Clin-ELISA kit. The samples utilized represent a mixed population of clinical patients (non-rubella disease related), newborns, employee/student screenings and pregnant women. Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated a relative sensitivity of 91% to 100% and a relative specificity of 97% to 100%. In addition, the assay displayed an overall agreement of 97% to 99%.

Further resolution of discrepant results by a commercial Rubella IgG EIA (Abbott Rubazyme EIA, 510(k) No. K885297) demonstrated that of the 5 samples positive by the INCSTAR Rubella IgG "fast" assay but negative by the reference ELISA assay, 3 were positive by the Rubazyme assay. Of the 3 samples negative by the INCSTAR Rubella IgG "fast" assay but positive by the reference ELISA assay, 2 were negative by the Rubazyme assay.

Prevalency, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR Rubella IgG "fast" Kit package insert. (See Section VII.A.1. Package Insert).