ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM

K033802 · Zeus Scientific, Inc. · DHR · Feb 27, 2004 · Immunology

Device Facts

• Record ID: K033802
• Device Name: ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: DHR · Immunology
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System is intended for the qualitative and/or quantitative detection of RF IgM class antibody. The test system is intended to be used as an aid in the diagnosis of rheumatoid arthritis. This test is for in vitro diagnostic use.

Device Story

Multiplexed bead-based immunoassay; detects RF IgM antibodies in human serum. Input: patient serum samples; multiplexed polystyrene beads conjugated with human IgG; phycoerythrin-conjugated goat anti-human IgM. Process: two-step incubation; RF IgM binds to IgG-coated beads; PE-conjugate binds to immobilized RF IgM. Instrument: AtheNA Multi-Lyte flow-cytometry system. Output: fluorescence intensity converted to IU/mL via internal calibration beads. Used in clinical laboratories; operated by trained technicians. Results aid physicians in rheumatoid arthritis diagnosis.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) regulatory review process.

Technological Characteristics

Multiplexed 5.6 micron polystyrene beads; flow-cytometry detection; phycoerythrin reporter; fluorescence signal. Calibrated against WHO 64/2 standard. Requires AtheNA Multi-Lyte instrument. Reportable range 0-238 IU/mL.

Indications for Use

Indicated for qualitative and quantitative detection of RF IgM class antibody in human serum as an aid in the diagnosis of rheumatoid arthritis.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Submission Summary (Full Text)

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FEB 27 2004

Food and Drug 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

Re: k033802 Trade/Device Name: AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System Regulation Number: 21 CFR § 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: II Product Code: DHR Dated: December 3, 2003 Received: December 29, 2003

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.

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, or questions 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 Division 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,

Joseph L. Arblett

Joseph L. Hackett, Ph.D. Acting 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 Form

(Appendix E)

510(k) Number (if known): Ko3 3802

AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System Device Name:

Indications for Use:

The Zeus Scientific, Inc. AtheNA Multi-Lyte™ Rheumatoid Factor IgM Test System is intended for the qualitative and quantitative detection of RF IgM class antibody in human serum. The test system is intended for the analysis of human serum for the presence of IgM RF. The test system is intended to be used as aid in the diagnosis of rheumatoid arthritis. The test is for in vitro diagnostic use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ V

OR

Over-The-Counter Use

(Per 21 CFR 801,109)

(Optional Format 1-

2-96)

Maria Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K03 3802