IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM

K982898 · Immco Diagnostics, Inc. · MOB · Nov 30, 1998 · Immunology

Device Facts

• Record ID: K982898
• Device Name: IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
• Applicant: Immco Diagnostics, Inc.
• Product Code: MOB · Immunology
• Decision Date: Nov 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

This assay is an indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum.

Device Story

ImmuGlo™ ANCA Test System is an indirect immunofluorescence assay (IFA) used to detect and semi-quantitate anti-neutrophil cytoplasmic antibodies in human serum. The device utilizes human polymorphonuclear (PMN) cells as a substrate on slides. Patient serum is applied to the substrate; if ANCA is present, it binds to the antigens in the PMN cells. A fluorescein-labeled anti-human IgG conjugate is then applied to visualize the bound antibodies via fluorescence microscopy. The test is performed in a clinical laboratory setting by trained personnel. Results are interpreted by observing fluorescence patterns, aiding clinicians in the diagnosis of necrotizing vasculitides. The system includes positive and negative control sera, buffered diluent, phosphate-buffered saline, and mounting medium to ensure standardized testing conditions.

Clinical Evidence

Clinical study compared IMMCO ImmuGlo™ to Scimedx ANCA IFA on 129 samples. Results: 49 positive/positive, 73 negative/negative, 7 positive/negative (IMMCO+/Scimedx-). Relative sensitivity 100%, relative specificity 91%, relative agreement 95%. Discrepant samples were further tested by ELISA for MPO/PR3; 6 of 7 discrepant samples were positive by ELISA, supporting the higher sensitivity of the IMMCO device.

Technological Characteristics

Indirect immunofluorescence assay using human PMN cell substrate. Components include fluorescein-labeled anti-human IgG conjugate, Evans Blue counterstain, positive/negative control sera, buffered diluent, phosphate-buffered saline, and mounting medium. Screening dilution is 1:20. Storage of substrate slides at 2°-8°C.

Indications for Use

Indicated for the detection and semi-quantitation of ANCA in human serum to aid in the diagnosis of patients with necrotizing vasculitides.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Predicate Devices

• Anti-neutrophil Cytoplasmic Antibody (ANCA) Test System (Scimedx Corporation)
• NOVA Lite™ ANCA System (INOVA Diagnostics)

Submission Summary (Full Text)

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NOV 3 0 1998

Image /page/0/Picture/1 description: The image shows a logo for IMMCO Diagnostics. The logo features a stylized letter "I" above the word "IMMCO" and the word "DIAGNOSTICS" below it. The letter "I" is large and bold, and the words "IMMCO" and "DIAGNOSTICS" are in a smaller, sans-serif font.

K982878

510(k) Notification ANCA IFA IMMCO Diagnostics, Inc.

# 510(k) Summary 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.

| Submitter: | IMMCO Diagnostics, Inc. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 60 Pineview Drive<br>Amherst, NY 14228 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Kevin Lawson |
| Date of Summary: | 8/13/98 |
| The assigned 510(k) number is: | K982898 |
| Name of Device: | ImmuGlo™ Anti-Neutrophil Cytoplasmic Antibody (ANCA) Test System |
| Common Name: | ANCA IFA |
| Classification Name: | 866.5660 Multiple autoantibodies immunological test system |
| Equivalent Device: | • Anti-neutrophil Cytoplasmic Antibody (ANCA) Test System<br>from Scimedx Corporation<br>• NOVA Lite™ ANCA System by INOVA Diagnostics |

### Intended Use:

This assay is an indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum.

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Image /page/1/Picture/0 description: The image is a logo for IMMCO Diagnostics. The logo features a stylized letter "I" in bold, black font, with a curved design at the top. Below the "I", the word "IMMCO" is printed in a bold, sans-serif font, with the word "DIAGNOSTICS" printed in a smaller font size underneath.

510(k) Notification ANCA IFA IMMCO Diagnostics, Inc.

## Technological Characteristics:

Technological characteristics of this device compared with the 2 equivalent devices listed above is summarized in the following table:

| | IMMCO | SciMedx | INOVA |
|------------------------------------------------------|--------------------|-----------------|-----------------|
| Indirect Immunofluorescence Assay | Y | Y | Y |
| Detection of Autoantibodies in Sera | ANCA | ANCA | ANCA |
| Screening for Ab's and/or Determination of Ab Titers | Y | Y | Y |
| Screening Dilution | 1:20 | 1:20 | 1:20 |
| Similar Methodology | Y | Y | Y |
| Substrate Used | human PMN cells | human PMN cells | human PMN cells |
| Fluorescein-Labeled Conjugate, Anti-human IgG | Y | Y | Y |
| Evans Blue Counterstain | in wash (optional) | in conjugate | in conjugate |
| Positive Control Sera | cANCA and pANCA | cANCA | cANCA and pANCA |
| Negative Control Serum | Y | Y | Y |
| Buffered Diluent | Y | Y | Y |
| Phosphate Buffered Saline | Y | Y | Y |
| Mounting Medium | Y | Y | Y |
| Storage of Substrate Slides | 2°-8°C | 2°-8°C | 2°-8°C |

# Clinical Test Data to Demonstrate Substantial Equivalence:

Substantial equivalence between the IMMCO and Scimedx assays is demonstrated in the table below.

| | | IMMCO | | |
|---------|----------|----------|----------|-------|
| | | Positive | Negative | Total |
| Scimedx | Positive | 49 | 0 | 49 |
| | Negative | 7 | 73 | 80 |
| | Total | 56 | 73 | 129 |

Relative Specificity: 91% Relative Sensitivity: 100% Relative Agreement: 95%

### Conclusions:

This test is substantially equivalent to that of Scimedx. The seven discrepant samples observed by indirect immunofluorescent method in the table above were tested by ELISA for antibodies to mveloperoxidase (MPO) or proteinase 3 (PR3) antigens, the two major antigens associated with ANCA. Of the seven samples positive on IMMCO's IFA system and negative on the Scimedx IFA system, all but one tested positive by ELISA, suggesting the true positivity of these samples. This discrepancy can therefore be accounted for by the greater sensitivity of the ImmuGlo™ Anti-Neutrophil Cytoplasmic Antibody (ANCA) Test System.

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Image /page/2/Picture/2 description: The image shows a partial view of a document with a logo and some text. The logo on the left features a stylized eagle or bird-like symbol, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". To the right of the logo, there is a partial date stamp that reads "NOV 30 19". The text is in a bold, sans-serif font, and the overall impression is that of an official document or letterhead.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kevin J. Lawson Chief Information Officer IMMCO DIAGNOSTICS 60 Pineview Drive Amherst, NY 14228

K982898 Re:

> Trade Name: ImmuGlo™ Anti-Neutrophil Cytoplasmic Antibody (ANCA) Test System Regulatory Class: II Product Code: MOB November 13, 1998 Dated: Received: November 16, 1998

Dear Mr. Lawson:

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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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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/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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510(k) Notification ANCA IFA IMMCO Diagnostics, Inc.

# INDICATIONS FOR USE STATEMENT

K982898 510(K) Number:

ImmuGlo" Anti-Neutrophil Cytoplasmic Antibody (ANCA) Test System Device Name:

Indications For Use:

An indirect immunofluorescence antibody test for the detection and semiquantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum to aid in the diagnosis of patients with necrotizing vasculitides.

Peter E. Maher

(Division Sign-Off, Division of Clinical Laboratory Devices 98 2898 510(k) Number

(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-Use (Optional Format 1-2-96)

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