MUMPS IGG ELISA TEST SYSTEM

K991274 · Columbia Bioscience, Inc. · LJY · Sep 3, 1999 · Microbiology

Device Facts

• Record ID: K991274
• Device Name: MUMPS IGG ELISA TEST SYSTEM
• Applicant: Columbia Bioscience, Inc.
• Product Code: LJY · Microbiology
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3380
• Device Class: Class 1

Intended Use

For the qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mumps infection. The evaluation of paired sera, to determine a significant increase in Mumps IgG antibody titer, can also aid in the diagnosis of acute infection by seroconversion through testing acute and convalescent sera. The test can be performed either manually or in conjunction with the MAGO® Plus Automated EIA processor. Performance characteristics have not been established on children.

Device Story

The Mumps IgG ELISA Kit is an indirect enzyme-linked immunosorbent assay (ELISA) for detecting IgG antibodies to Mumps virus in human serum. Purified Mumps antigen is bound to microwells; patient serum is added, allowing anti-Mumps IgG to bind to the antigen. After washing, horseradish peroxidase-labeled anti-human IgG conjugate is added, followed by a substrate that produces a colorimetric end product. The absorbance is measured spectrophotometrically at 450 nm (reference 600-630 nm), with intensity directly proportional to the concentration of Mumps IgG antibodies. The test is performed in clinical laboratories either manually or using the MAGO® Plus Automated EIA processor. Results assist clinicians in diagnosing Mumps infection and identifying acute infection through seroconversion in paired sera. The device provides quantitative index values to aid clinical decision-making.

Clinical Evidence

Clinical performance evaluated by comparing the subject device against a commercial Mumps IgG ELISA using 173 patient serum samples. Results showed 100% relative sensitivity (95% CI: 97.7%-100%), 76.9% relative specificity (95% CI: 46.2%-95.0%), and 98.3% overall agreement (95% CI: 95.0%-99.5%). Reproducibility was assessed across three sites using six serum samples (four positive, two negative) in both manual and MAGO® Plus automated formats, demonstrating consistent inter-assay and intra-assay performance. Correlation between manual and automated procedures yielded a Pearson correlation coefficient of 0.954.

Technological Characteristics

Indirect ELISA using purified Mumps antigen bound to microwells. Detection via horseradish peroxidase-labeled anti-human IgG conjugate and colorimetric substrate. Absorbance measured spectrophotometrically at 450 nm. Compatible with manual processing or the MAGO® Plus Automated EIA processor. In vitro diagnostic reagent.

Indications for Use

Indicated for qualitative and semi-quantitative detection of IgG antibodies to Mumps virus in human serum of adults >18 years. Used as an aid in diagnosis of Mumps infection and acute infection via paired sera (acute/convalescent) seroconversion. Not established for use in children.

Regulatory Classification

Identification

Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.

Predicate Devices

• Wampole Mumps IgG ELISA Kit

Submission Summary (Full Text)

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SEP 3 1999

LG91274

Job 497

# 510k Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92

The assigned 510(k) number is

### Applicant Information

| Date Prepared: | March 29, 1999 |
|-----------------|-------------------------------------------------------|
| Name: | Columbia Bioscience, Inc. |
| Address: | 8775 M Centre Park Ddrive, #559<br>Columbia, MD 21045 |
| Contact Person: | Norman Jenkins |

Comfact Person PhoneNumber. 410-995-1278 410-995-0508 Fax Number

### Device Information:

| Trade Name | ් Mumps IgG ELISA Kit |
|----------------------|---------------------------|
| Common Name | Mumps lgG EIA Test |
| Classification Name: | Mumps Serological Reagent |

Equivalent Device: Wampole Mumps IgG ELISA Kit

Device Description: The & Mumps IgG ELISA Kit is an Enzyme-Linked ImmunoSorbent Assay (E.I.S.A) (6) the detection of IgG antibodies to Mumps antigen in human serum.

Intended Use: For the qualitative and semi-quantitative determination of IgGi antibodies to Mumps virus m human serum of adults over cighteen vears of age by indirect enzyme immunoassay as an aid in the diaunosis at Mumps infection. The evaluation of paired sera, to determine a significant increase in Mumps IgG antihody itel can also aid in the diagnosis of acute infection by seroconversion through testing acute and convalescent sera. The test can be performed either manually or in conjunction with the MAGO® Plus Automated EIA processor. Performance characteristics have not been established on children

### Principle of Procedure:

Purified Mumps antigen is bound to microwells. Diluted patient sera, Cut-Off Calibrator and controls are placed in the microwells and incubated. Anti-Mumps IgG antibodies, if present, will bind to the antigen forming antigenantibody complexes. Residual sample is eliminated by aspirating Conjugate (horseradish peroxidase-labeled anti-human IgG) is added and will bind to these complexes. Unbound conjugate is removed by aspiration and washing. Substrate is then added and incubated In the presence of bound enzyme the substrate is converted to an end product. The absorbance of this end product can be read spectrophotometrically at 4.0 nm (reference 600-630 mm) and is directly proportional to the concentration of 126 antibodies to Mumps present in the sample.

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# Performance Characteristics

# A. Comparison with Another ELISA Test

Fresh sera from one hundred seventy-thece patients were tested at a chnical commercial laboratory, hosacd m the Mid-Atlante area, using the Is-Munps IgG Test Kit and a commercially available kit for Mumps IgG antibodies. The data in Table is show the relative sensitivity, specificity and overall agreement of the Is-Mumps IgG Test Kit versus this commercial Mumps IgG ELISA.

#### TABLE I

| /s-Mumps IgG Test Kit | | |
|-----------------------|--|--|

| | ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺪﻡ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺪﻡ ﺍﻟﻤﺘ | *FQUIVOCAL | NEGATIVE |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------|
| POSITIVE | l ()() | () | () |
| *1:QUIVOCAL | () | () | () |
| NEGALIVE: | ું એ: મઃ | 34. *** | (() |

( )ther 1 :1 TISA

95% Cl

| Relative Sensitivity = 160/160 = 100% | | 97.7% - 100% |
|---------------------------------------|--|---------------|
| Relative Specificity = 10/13 = 76.9% | | 46.2% - 95.0% |
| Overall Agreement = 170/173 = 98.3% | | 95.0% - 99.5% |

* Equivocal results were excluded from ealeutlations.

** 313 sera were positive by IFA.

*** 373 sera were positive by II/A

NOTE : Please be advised that 'refers to the comparison of the assay's results to that of a sumta assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison's accuracy to predict discase.

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### B. Reproducibility

To decemine the reproducibility of the Is-Mumps IgG Test Kit, four positive and two negative sera were assayed Ien to decembe tic repredictions of the as manipalign included: the manufacturer, a research and development laboratory, and a clineral career and interassay reproducibility obtained at cach site is shown in Tables2 , 3 and 9.

| SERUM | INTRA-ASSAY RUN 1<br>MEAN<br>INDEX | CV% | INTRA-ASSAY RUN 2<br>MEAN<br>INDEX | CV% | INTRA-ASSAY RUN 3<br>MEAN<br>INDEX | CV% | INTERASSAY<br>MEAN<br>INDEX | CV% |
|---------|------------------------------------|-------|------------------------------------|-------|------------------------------------|-------|-----------------------------|-------|
| A (POS) | 1.11 | 4.26 | 1.17 | 8.82 | 1.24 | 8.90 | 1.17 | 8.70 |
| B (POS) | 1.26 | 5.19 | 1.34 | 6.04 | 1.38 | 4.82 | 1.33 | 6.36 |
| C (POS) | 1.95 | 9.02 | 2.02 | 5.33 | 2.17 | 4.22 | 2.05 | 7.55 |
| D (POS) | 1.74 | 7.27 | 1.64 | 6.67 | 1.73 | 7.68 | 1.70 | 7.48 |
| E (NEG) | 0.15 | 40.25 | 0.18 | 23.53 | 0.23 | 21.39 | 0.18 | 32.18 |
| F (NEG) | 0.14 | 39.81 | 0.13 | 39.09 | 0.16 | 39.88 | 0.14 | 39.03 |

TABLE 2 : Site #1 - Intra-Assay and Interassay Reproducibility

| | TABLE 1: Site #2 - Intra-Assay and Interassay Reproducibility | | |
|--|---------------------------------------------------------------|--|--|
| | | | |

| SERUM | INTRA-ASSAY RUN 1<br>MEAN INDEX | CV% | INTRA-ASSAY RUN 2<br>MEAN INDEX | CV% | INTRA-ASSAY RUN 3<br>MEAN INDEX | CV% | INTERASSAY<br>MEAN INDEX | CV% |
|---------|---------------------------------|-------|---------------------------------|-------|---------------------------------|-------|--------------------------|-------|
| A (POS) | 1.188 | 6.30 | 1.248 | 6.53 | 1.371 | 9.35 | 1.269 | 9.63 |
| B (POS) | 1.384 | 10.51 | 1.338 | 6.30 | 1.515 | 6.57 | 1.412 | 9.43 |
| C (POS) | 2.110 | 6.94 | 1.976 | 6.74 | 2.247 | 8.75 | 2.111 | 9.09 |
| D (POS) | 1.673 | 4.86 | 1.738 | 7.98 | 1.949 | 5.05 | 1.787 | 8.92 |
| E (NEG) | 0.227 | 9.44 | 0.247 | 15.95 | 0.314 | 11.60 | 0.263 | 18.06 |
| F (NEG) | 0.175 | 8.14 | 0.198 | 4.37 | 0.228 | 8.18 | 0.200 | 13.02 |

TABLE4 : Site #3 - Intra-assay and Interassay Reproducibility

| SERUM | INTRA-ASSAY RUN 1 | | INTRA-ASSAY RUN 2 | | INTRA-ASSAY RUN 3 | | INTERASSAY | |
|---------|-------------------|-------|-------------------|-------|-------------------|-------|------------|-------|
| | MEAN INDEX | CV% | MEAN INDEX | CV% | MEAN INDEX | CV% | MEAN INDEX | CV% |
| A (POS) | 1.21 | 10.20 | 1.24 | 7.00 | 1.18 | 6.15 | 1.21 | 8.04 |
| B (POS) | 1.31 | 4.49 | 1.31 | 2.57 | 1.31 | 5.12 | 1.31 | 4.06 |
| C (POS) | 2.10 | 7.04 | 2.08 | 5.84 | 2.09 | 6.51 | 2.09 | 6.28 |
| D (POS) | 1.83 | 5.75 | 1.71 | 8.72 | 1.67 | 4.69 | 1.74 | 7.54 |
| E (NEG) | 0.28 | 34.40 | 0.24 | 15.53 | 0.16 | 24.35 | 0.23 | 35.19 |
| F (NEG) | 0.20 | 15.41 | 0.21 | 8.87 | 0.16 | 15.88 | 0.19 | 17.49 |

# C. Correlation of Manual and MAGO Plus Results

The 1/-Mumps IgG Test Kit has been developed for antomated as . To demonstrate the equivalence of the manual and MAGO Plus procedures, the results of 153 serum samples, were plotted. A scattergram and regression line of the results oblained with 95% confidence intervals is shown in ligure 1. The data indicate good correlation with a Pearson Correlation Coefficient of 0.954.

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Image /page/3/Figure/3 description: The image shows the title of a figure. The title is "FIGURE I : Manual and MAGO Plus Result Correlation". The title is written in a bold, sans-serif font.

Image /page/3/Figure/4 description: The image is a scatter plot that shows the relationship between manual index values and MAGO plus index values. The x-axis represents the manual index values, and the y-axis represents the MAGO plus index values. The plot includes a regression line with the equation Y = 0.1382 + 0.9552X, and the correlation coefficient r = 0.9537, indicating a strong positive correlation between the two variables.

# D. MAGO Plus Reproducibility

The reproducibility of the assay when performed on the MACO Plus Automated FIA Processor was determined by assaying six sera ten times each in three different runs, Tables shows the interassy reproducibility obtanced using the MAGO Plus.

| SERUM | INTRA-ASSAY RUN 1 | | INTRA-ASSAY RUN 2 | | INTRA-ASSAY RUN 3 | | INTERASSAY | |
|---------|-------------------|-------|-------------------|-------|-------------------|-------|---------------|-------|
| | MEAN<br>INDEX | CV% | MEAN<br>INDEX | CV% | MEAN<br>INDEX | CV% | MEAN<br>INDEX | CV% |
| A (POS) | 1.2 | 9.26 | 1.3 | 10.04 | 1.2 | 9.91 | 1.2 | 10.03 |
| B (POS) | 1.4 | 11.60 | 1.5 | 6.92 | 1.5 | 13.06 | 1.5 | 11.50 |
| C (POS) | 2.2 | 10.96 | 2.3 | 8.93 | 2.3 | 8.72 | 2.2 | 9.62 |
| D (POS) | 1.9 | 10.27 | 1.9 | 8.06 | 1.8 | 8.42 | 1.9 | 8.84 |
| E (NEG) | 0.2 | 28.41 | 0.2 | 0.00 | 0.2 | 23.57 | 0.2 | 21.19 |
| F (NEG) | 0.1 | 0.00 | 0.1 | 28.75 | 0.1 | 28.75 | 0.1 | 23.79 |

TABLE 5 : Site #2-Intra-Assay and interassay Reproducibility - MAGO Plus

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them.

SEP 3 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DIAMEDIX Corporation c/o Mr. William Boteler ImmunoProbe, Inc. 1306F Bailes Lane Frederick, Maryland 21701

Re: K991274 Trade Name: Mumps IgG ELISA Test System Regulatory Class: I Product Code: LJY Dated: June 25, 1999 Received: June 28, 1999

Dear Mr. Boteler:

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 QS 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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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Page I of I

510(k) Number: Not Known

Device Name: & Mumps IgG ELISA

Indications For Use: For the qualitative and semi-quantitative determination of G antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mumps infection. The evaluation of paired sera, to determine a significant increase in Mumps IgG antibody titer, can also aid in the diagnosis of acute infection by seroconversion determination through testing acute and convalescent sera. The test can be performed either manually or in conjunction with the MAGO® Plus Automated E1A processor Performance characteristics have not hecn established on children

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Lise
(Optional Format 1-2-96)

Woody Dubois
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number. K991274