MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM

K021103 · Zeus Scientific, Inc. · LKJ · Apr 24, 2002 · Immunology

Device Facts

• Record ID: K021103
• Device Name: MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: LKJ · Immunology
• Decision Date: Apr 24, 2002
• 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, Histone) 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 this in namautoimmune disorders. This test is for in vitro diagnostic use.

Device Story

AtheNA Multi-Lyte™ ANA Test System is an in vitro diagnostic assay for human serum. It detects IgG class antibodies to 8 specific analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, Histone) semiquantitatively, dsDNA quantitatively, and ANA qualitatively. Used in clinical laboratories to aid in the diagnosis of autoimmune disorders. The system utilizes multiplexed bead-based technology to identify specific antibodies. Results are interpreted by healthcare providers to support clinical decision-making regarding autoimmune disease diagnosis.

Technological Characteristics

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

Indications for Use

Indicated for the detection of IgG class antibodies to SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, Histone, dsDNA, and ANA in human serum as an aid in the diagnosis of autoimmune disorders.

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).

Predicate Devices

• K014244

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

## APR 2 4 2002

ood and Drug Administratio 2098 Gaither Road Rockville MD 20850

Mr. Mark J. Kopnitsky Vice President, Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, NJ 08876

k021103 Re:

K021103
Trade/Device Name: Zeus Scientific Inc., AtheNA Multi-Lyte™ ANA Test System Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LKJ Dated: April 3, 2002 Received: April 5, 2002

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 for association 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.

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 nouncation. The I Drice results in 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 CFF Part 801 and 1 11 you desire specific active to your astic devices), please contact the Office of Compliance at additionally 807.10 for m viro allegiestions on the promotion and advertising of your device, [phone]. Tructionally, respect [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional 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,

Steven Putman

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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Section II: Indications for Use Form

K021103

Page

510(k) Number (if known): -K014244

Device Name: Zeus Scientific, Inc., AtheNA Multi-Lyte™ ANA 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, RNP, Scl-70, Jo-1, Centromere B, Histone) 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 this in namautoimmune disorders. This test is for in vitro diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Sousan S. Altare
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K021103 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over-The-Counter Use |
|----------------------|--------------------------------------------|----|----------------------|
| (Per 21 CFR 801,109) | | | (Optional Format 1- |
| 2-96) | | | |