ATHENA MULTI-LYTE ANA-II TEST SYSTEM

K042416 · Zeus Scientific, Inc. · LKJ · Oct 8, 2004 · Immunology

Device Facts

• Record ID: K042416
• Device Name: ATHENA MULTI-LYTE ANA-II TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: LKJ · Immunology
• Decision Date: Oct 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte® ANA Test System is intended for the semiquantitative detection of IgG class antibody to 8 separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and dsDNA) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum and the qualitative detection of IgG class antibody to ANA in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune disorders. This test is for in vitro diagnostic use.

Device Story

AtheNA Multi-Lyte ANA-II Test System is an in vitro diagnostic assay for detecting IgG antibodies in human serum. It utilizes multiplexed bead-based technology to identify antibodies against 8 specific nuclear antigens (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, dsDNA) and general ANA. The system processes serum samples to provide semiquantitative or quantitative results, aiding clinicians in diagnosing autoimmune disorders. It is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Method comparison between modified assay and original assay performed. Acceptance criteria: relative agreement ≥90% and comparable read times. Design control activities and risk analysis per EN 1441 conducted to verify modification impact.

Technological Characteristics

Multiplexed bead-based immunoassay system for the detection of IgG class antibodies. Designed for in vitro diagnostic use in clinical laboratory environments.

Indications for Use

Indicated for use as an in vitro diagnostic test system for the detection of antinuclear antibodies (ANA) in human serum.

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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Re:

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Mr. Mark J. Kopnitsky Vice President, Research and Development Zeus Scientific, Inc. 200 Evans Way Branchburg, New Jersey 08876

> k042416 Trade/Device Name: AtheNA Multi-Lyte™ ANA-I1 Test System Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: II Product Code: LKJ Dated: September 23, 2004 Received: September 28, 2004

## Dear Mr. Kopnitsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.

OCT 7 - 2004

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

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If you desire specific information about the application of labeling requirements to your device, r you stime on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va inaly of Small Manufacturers, International and Consumer 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. 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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Section II. Indications for Use.

## Indications for Use

510(K) Number (if known): K042416

Device Name: AtheNA Multi-Lyte ANA-II Test System

Indications for Use:

The Zeus Scientific, Inc. AtheNA Multi-Lyte® ANA Test System is intended for the semiquantitative detection of IgG class antibody to 8 separate analytes (SSA, SSB, Sm, Quartitative dotoon of igo blace annova) in human serum, the quantitative detection And , Oor C, o T, Sen. On human serum and the qualitative detection of IgG class antibody to ANA in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune disorders. This test is for in vitro diagnostic use.

Prescription Use (Part21 CFR 801 Subpart D)

AND/OR . -

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

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

Mana Chan

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042416