IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA

K041102 · Immco Diagnostics, Inc. · LJM · Oct 26, 2004 · Immunology

Device Facts

• Record ID: K041102
• Device Name: IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
• Applicant: Immco Diagnostics, Inc.
• Product Code: LJM · Immunology
• Decision Date: Oct 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ImmuLisa™ Anti-Nuclear Antibody (ANA) Screen ELISA is an enzyme linked immunosorbent assay for the detection of antinuclear and cytoplasmic antibodies in human serum to aid in the diagnosis of autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Sjögren’s Syndrome (SS), Mixed Connective Tissue Disease (MCTD) and Scleroderma.

Device Story

ImmuLisa™ ANA Screen ELISA is a solid-phase immunoassay for detecting antinuclear and cytoplasmic antibodies in human serum. The kit utilizes microwells coated with Hep-2 nuclear and cytoplasmic antigens. Patient serum is incubated in wells; ANA present binds to immobilized antigens. After washing, enzyme-labeled anti-human IgG conjugate is added, followed by TMB substrate. Color intensity, proportional to antibody concentration, is measured via spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/mL). The device is intended for prescription use in clinical laboratories. It aids physicians in diagnosing autoimmune conditions by providing semi-quantitative antibody levels. It replaces traditional immunofluorescence methods with an automated-compatible ELISA format, potentially increasing throughput and standardizing result interpretation.

Clinical Evidence

No clinical prospective or retrospective studies provided. Performance established via method comparison study of 292 samples (107 normal, 55 disease controls, 7 SLE, 123 ANA-positive) against predicate IFA. Results: 95% positive agreement, 96% negative agreement, 96% total agreement. Analytical performance included precision (inter-assay CV 5.2-6.4%, intra-assay CV 6.8-8.1%) and interference testing (no significant effect from lipemic, hemolytic, jaundiced, or icteric sera).

Technological Characteristics

Solid-phase ELISA; microwells coated with Hep-2 nuclear/cytoplasmic antigens. Detection via horseradish peroxidase-labeled anti-human IgG conjugate and TMB substrate. Requires microplate reader (450 nm) and automatic washer. Semi-quantitative output in EU/mL. No specific material standards cited.

Indications for Use

Indicated for the detection of antinuclear and cytoplasmic antibodies in human serum to aid in the diagnosis of autoimmune diseases including Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome (SS), Mixed Connective Tissue Disease (MCTD), and Scleroderma.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 6 2004

Mr. Kevin J. Lawson Director, Regulatory Affairs IMMCO Diagnostics, Inc. 60 Pineview Drive Buffalo, New York 14228-2120

k041102 Re:

Ko 11102
Trade/Device Name: ImmuLisa Antinuclear Antibody Screen ELISA Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: II Product Code: LJM Dated: September 30, 2004 Received: October 7, 2004

Dear Mr. Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becalling in (a) pening is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encroours) to trgang ment date of the Medical Device Amendments, or to connitier provision to may 20, 1978, the occordance with the provisions of the Federal Food, Drug, de vices mat nave been receire approval of a premarket approval application (PMA). and Cosmetic Ac. (11ct) that to nov requent of the general controls provisions of the Act. The 1 ou may, cherefore, mans of the Act include requirements for annual registration, listing of general controls profitering practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olabsined (600 as colorols. Existing major regulations affecting your device can may be subject to sach adamental vol Regulations (CFR), Parts 800 to 895. In addition, FDA be round in Triro levels with the soncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast of advised that I Drivedance or our device complies with other requirements of the Act that I Dri has made a word regulations administered by other Federal agencies. You must or any I catal battler and states and and the begine to registration and listing (21 CFR Parts 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CPR Part 607), adoming (21 Ce quality systems (QS) regulation (21 CFR Part 820). This letter requirenches as set form in are quality device as described in your Section 510(k) premarket will anow you to begin marketing your antial equivalence of your device to a legally marketed nonfication. The PDF in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, and In If you desire specific information and advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your and accept of the of questions of the promotion and ad retising 65 301) 594-3084. Also, please note the Vitro Diagnostic Device Livanianon and Baroy in ( = ( = ) = ( = ) = ( = ( Part 807.97).
regulation entitled, "Misbranding by reference to premarket the Ast from the regulation entitled, "Misolanung by reiclenes on your responsibilities under the Act from the You may obtain other gelefal informations on Jour responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker, Jr.

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): K041102

Device Name:

ImmuLisa Antinuclear Antibody Screen ELISA

Indications For Use:

An enzyme linked immunoassay (ELISA) for the detection of antinuclear and cytoplasmic antibodies in human serum to aid in antinuclear and cytoplashiks artibeares such as Systemic Lupus
the diagnosis of autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome (SS), Mixed Erythematoous (Sease (MCTD), and Scleroderma.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mana Chan
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Office of In Vitro Diagnostic Device Evaluation and Safety

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