ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM

K040111 · Zeus Scientific, Inc. · MOB · Apr 5, 2004 · Immunology

Device Facts

• Record ID: K040111
• Device Name: ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: MOB · Immunology
• Decision Date: Apr 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte™ MPO/PR3 Test System is for the qualitative and semi-quantitative detection of IgG autoantibodies to human myeloperoxidase (MPO) and/or human proteinase 3 (PR3) in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of systemic vasculitides (SV). This test is for in vitro diagnostic use.

Device Story

Multiplexed flow cytometry-based immunoassay; detects IgG antibodies to MPO and PR3 antigens. Input: human serum samples. Process: patient serum mixed with differentially colored polystyrene microspheres conjugated with MPO or PR3; incubated; washed; reacted with phycoerythrin-conjugated goat anti-human IgG. Output: fluorescence intensity measured by AtheNA Multi-Lyte instrument; internal calibration beads convert raw fluorescence to units. Used in clinical laboratories; operated by trained personnel. Results aid clinicians in diagnosing systemic vasculitides alongside other clinical findings.

Clinical Evidence

Clinical study evaluated 445 specimens (150 normal, 122 routine, 173 clinically defined). MPO sensitivity 60.8% (95% CI 49.7-71.9%), specificity 93.3% (95% CI 89.3-97.3%). PR3 sensitivity 55.2% (95% CI 43.3-67.1%), specificity 78% (95% CI 71.4-84.63%). Method comparison against ELISA showed 90.6% total agreement for MPO and 86.2% for PR3.

Technological Characteristics

Multiplexed fluorescent immunoassay using 5.6 micron carboxylated polystyrene microspheres. Energy source: fluorescence excitation/detection via AtheNA Multi-Lyte instrument. Connectivity: standalone instrument. Calibration: Intra-Well Calibration Technology using internal bead sets. Reagents: phycoerythrin-conjugated goat anti-human IgG.

Indications for Use

Indicated for qualitative/semi-quantitative detection of IgG autoantibodies to human MPO and/or PR3 in human serum to aid in diagnosis of systemic vasculitides (e.g., Wegener's Granulomatosis, ICGN, MPA, PRS). Prescription use only.

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).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged around the circumference of the circle.

Public Health Service

APR = 5 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k040111

Trade/Device Name: AtheNA Multi-Lite™ MPO/ PR3 IgG Test System Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MOB Dated: January 13, 2004 Received: February 13, 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.

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).

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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. Arlett

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):

AtheNA Multi-Lyte™ MPO/PR3 Test System Device Name:

Indications for Use:

The Zeus Scientific, Inc. AtheNA Multi-Lyte™ MPO/PR3 Test System is for the qualitative and semi-quantitative detection of IgG autoantibodies to human myeloperoxidase (MPO) and/or human proteinase 3 (PR3) in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of systemic vasculitides (SV). 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)

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

5100k) Ko4011