DIAMEDIX IS-MEASLES IGG TEST SYSTEM

K974552 · Diamedix Corp. · LJB · Jan 28, 1998 · Microbiology

Device Facts

• Record ID: K974552
• Device Name: DIAMEDIX IS-MEASLES IGG TEST SYSTEM
• Applicant: Diamedix Corp.
• Product Code: LJB · Microbiology
• Decision Date: Jan 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3520
• Device Class: Class 1

Intended Use

The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus , to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection.

Device Story

Is-Measles IgG Test System is an ELISA for semi-quantitation of IgG antibodies to measles virus in human serum. Principle: partially purified measles virus antigen attached to microtiter well; patient serum added; if specific IgG present, it binds to antigen; unbound antibody washed away; enzyme-labeled anti-human immunoglobulin conjugate added; unbound conjugate washed away; substrate solution added; color intensity measured photometrically. Output: photometric absorbance proportional to specific antibody concentration. Used in clinical laboratories; operated by laboratory technicians. Results aid clinicians in assessing immune status and diagnosing measles infection.

Clinical Evidence

Bench testing only. Evaluated 204 sera from normal blood donors comparing Is-Measles IgG to a commercial anti-measles IgG EIA. Manual method: 95.6% sensitivity, 100% specificity, 96.2% overall agreement. MAGO automated method: 94.0% sensitivity, 96.2% specificity, 94.3% overall agreement. Precision (intra/inter-assay CVs) and linearity (r=0.9969-0.9983) demonstrated. No cross-reactivity observed with varicella, CMV, herpes 2, or rubella antibodies.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA). Solid phase: microtiter well coated with partially purified measles virus antigen. Detection: enzyme-labeled anti-human immunoglobulin conjugate with photometric substrate. Form factor: microtiter plate. Connectivity: manual or automated (MAGO system).

Indications for Use

Indicated for semi-quantitative detection of IgG antibodies to measles virus in human serum to assess immunological response, determine immune status, and aid in diagnosis of measles infection via paired sera evaluation.

Regulatory Classification

Identification

Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.

Predicate Devices

• Diamedix Measles IgG Microassay

Submission Summary (Full Text)

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# JAN 2 8 1998 8974552

# Appendix E. 510(k) Summary of Safety and Effectiveness

# The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

Name: Address: Diamedix Corporation 2140 N. Miami Avenue Miami, FL 33127

Contact Person: Phone Number: Fax Number:

Dr. Lynne Stirling 305-324-2354 305-324-2585

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## 510(k) Summary of Safetv 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: | December 3, 1997 |
|----------------|-----------------------------------------|
| Name: | Diamedix Corporation |
| Address: | 2140 N. Miami Avenue<br>Miami, FL 33127 |

| Contact Person: | Dr. Lynne Stirling |
|-----------------|--------------------|
| Phone Number: | 305-324-2354 |
| Fax Number: | 305-324-2585 |

#### Device Information:

| Trade Name: | Is-Measles IgG Test System |
|----------------------|--------------------------------------------|
| Common Name: | Measles EIA Test |
| Classification Name: | Enzyme linked immunosorbent assay, rubeola |

#### Equivalent Device:

Diamedix Measles IgG Microassay

Device Description: The Is-Measles IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Measles (rubeola) antigen in human serum

Intended Use: The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus , to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection.

#### Principle of Procedure:

The Is-Measles IgG Test System is an enzyme-linked immunosorbent assay to detect IgG to measles virus in human serum. Partially purified measles virus antigen is attached to a solid phase (microtiter well). Diluted test sera are added to each well. If antibodies which recognize the measles antigen are present in the patient sample they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human immunoglobulin (conjugate) is added to each test well. If antibody is present the enzyme-linked antibody will bind to it. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is then added to each well. If enzyme is present from prior step, the reaction is stopped and the color intensity is measured photometrically producing an indirect measure of the specific antibody present in the patient sample.

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#### SUMMARY OF SAFETY AND EFFECTIVENESS

#### Performance Characteristics

#### A. Comparison Testing

The Diamedix Is-Measles IgG test kit was evaluated relative to another commercially available anti-measles IgG EIA. Two hundred and four sera from normal blood donors were tested by the Is-Measles IgG and a commercially obtained anti-measles IgG test kit. The results are summarized in Table 1 below.

| | Manual | | | MAGO | | |
|-------------------------|-------------------|-------|------------|-------------------|------|-----------|
| Table 1 | Number of<br>Sera | % | 95% CI | Number of<br>Sera | % | 95% CI |
| Relative<br>Sensitivity | 152/159 | 95.6 | 91.1-98.2 | 156/166 | 94.0 | 89.2-97.1 |
| Relative<br>Specificity | 25/25 | 100.0 | 86.3-100.0 | 25/26 | 96.2 | 80.4-99.9 |
| Overall<br>Agreement | 177/184 | 96.2 | 92.3-98.5 | 181/192 | 94.3 | 90.0-97.1 |

20 equivocal samples excluded from caluclations

12 equivocal samples excluded from calculations

#### B. Linearity

Figures 1 and 2 show tyoical examples of Is-Measles IgG linearity. These figures depict the results of the Calibrator tested by the Is-Measles test kit safter a serial 2-fold manual dilution in Sample Diluent. Separate dilutions were tested both manually and with MAGO. These results demonstrate a high degreee of lineaity for the Is Measles test kit thorout the reportable range using either test method.

Figure 2 : MAGO Linearity

Image /page/2/Figure/9 description: The image shows the title of a figure. The title is "Figure 1 : Manual Linearity". The title is written in a clear, sans-serif font and is centered on the image.

Image /page/2/Figure/10 description: The image contains two line graphs comparing calibrator titration methods. The graph on the left shows "Calibrator Titration: Manual" with an r-value of 0.9969 and a 95% confidence interval for r between 0.8557 and 0.9999. The graph on the right shows "Calibrator Titration: MAGO" with an r-value of 0.9983 and a 95% confidence interval for r between 0.9161 and 1.0000. Both graphs plot "Absorbance" on the y-axis against "Dilution factor" on the x-axis, showing a positive correlation between the two variables.

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#### C. Precision

The precision of the Is-Measles IgG test kit was determined by testing 6 different sera and the kit calibrator and controls in two runs on three different days. The intra- and interassay precison, both manually and using the MAGO is shown in Table 2.

| Table 2 | Is-Measles IgG Precision | | | | |
|------------|--------------------------|-----------|-----------|-----------|-----------|
| | | MANUAL | | MAGO | |
| SERUM | Overall<br>MEAN (EU/ml) | INTRA-CV% | INTER-CV% | INTRA-CV% | INTER-CV% |
| A (Neg) | 7.6 | 9.9 | 15.5 | 5.4 | 7.0 |
| B (Neg) | 4.3 | 15.1 | 31.6 | 10.5 | 13.2 |
| C (Pos) | 32.7 | 7.5 | 8.3 | 6.8 | 8.0 |
| D (Pos) | 50.9 | 8.6 | 8.8 | 5.7 | 7.5 |
| E (Pos) | 85.1 | 6.3 | 8.5 | 8.5 | 10.2 |
| F (Pos) | 103.3 | 7.2 | 10.7 | 5.1 | 10.6 |
| Calib. | 106.4 | 6.4 | 8.9 | 7.2 | 8.8 |
| Pos. Ctrl. | 51.1 | 6.3 | 12.1 | 6.3 | 9.4 |
| Neg. Ctrl. | 3.5 | 10.5 | 16.3 | 16.6 | 24.3 |

#### D. Cross-Reactivity

Twenty sera, negative for antibodies to measles virus, were tested for IgG antibody to varicella, cytomegalovirus, herpes 2 and rubella. All the measles-negative sera were positive to one or more of the anlaytes tested. This suggests that no specific cross-reactivity should be expected with the Is-Measles IgG from these analytes.

#### E. Expected Values

Sera from one hundred randomly selected South Florida blood donors were evaluated in the Is-Measles Ig test kit. Eighty-eight sera were positive, 8 were negative and 4 were equivocal for measles for measles IgG antibodies. The distribution of EU/ml values is shown in Figures 3 and 4.

Image /page/3/Figure/7 description: The image contains two bar charts, "Figure 3: Is Measles IgG Positive Population" and "Figure 4: Is Measles IgG Negative Population". The first chart shows the frequency of measles IgG positive populations with EU/mL values ranging from 20-40 to >100, with the >100 range having the highest frequency at approximately 36. The second chart shows the frequency of measles IgG negative populations with EU/mL values ranging from 1-5 to 16-20, with the 1-5 range having the highest frequency at approximately 4.

#### F. Manual vs MAGO Correlation

Numerical comparison of EU/ml values, between manual and MAGO results for 204 samples in the Is-Measles test kit gave a correlation coefficient (r) of 0.961 (95%CI for r : 0.949 to 0.9708).

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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 stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the logo.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 8 1998

Lynne Stirling, Ph.D. Vice President, Research & Development Diamedix Corporation 2140 North Miami Avenue Miami, FL 33127

Re: K974552

> Trade Name: Diamedix Is-Measles IgG Test System Regulatory Class: I Product Code: LJB Dated: December 3, 1997 Received: December 4, 1997

Dear Dr. Stirling:

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 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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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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# Appendix G. Indications for Use Statement

## INDICATIONS FOR USE STATEMENT

**510(K) NUMBER**: K974552

# DEVICE NAME : Is-Measles IgG Test System

Indications for Use :The Diamedix Is-Measles IgG test system is an Enzyme Immunoassay (EIA) for the semi-quantitative detection of IgG antibodies in human serum to measles virus as an aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals, and, when evaluating paired sera, as an aid in the diagnosis of measles infection.

Volin Ticehurst MD

(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number_ Kiri

Prescription Use V (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)

000247