ATHENA MULTI-LYTE EBV IGG TEST SYSTEM

K042118 · Zeus Scientific, Inc. · JRY · Apr 29, 2005 · Microbiology

Device Facts

• Record ID: K042118
• Device Name: ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: JRY · Microbiology
• Decision Date: Apr 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Intended Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte® EBV IgG Test System is intended for the qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA gp-125, EBV-EA “total” and recombinant EBNA-1) in human serum using the AtheNA Multi-Lyte® System. The test system is intended to be used as an aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and to provide epidemiological information on the disease caused by Epstein-Barr virus.

Device Story

Multiplexed immunoassay system detects IgG antibodies to EBV antigens (VCA, EBNA-1, EA) in human serum. Input: diluted patient serum incubated with polystyrene microspheres conjugated with specific EBV antigens; non-specific binding and calibration beads included. Process: secondary incubation with phycoerythrin-conjugated goat anti-human IgG; AtheNA Multi-Lyte instrument (Luminex LS-100) sorts beads and measures fluorescence. Output: quantitative units derived via Intra-Well Calibration Technology (internal multi-point standard curve). Used in clinical laboratories; operated by technicians. Results aid clinicians in diagnosing EBV-associated infectious mononucleosis and determining disease stage (acute, past, or no infection) based on antibody profiles.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Multiplexed immunoassay system for qualitative detection of IgG antibodies. Uses specific EBV antigens (VCA, EA, EBNA-1). Designed for use with the AtheNA Multi-Lyte instrument platform.

Indications for Use

Indicated for qualitative detection of IgG class antibodies to EBV-VCA, EBV-EA, and EBNA-1 in human serum to aid in laboratory diagnosis of EBV-associated diseases. For prescription use only.

Regulatory Classification

Identification

Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).

Submission Summary (Full Text)

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 9 2005

Mr. Mark J. Kopnitsky Vice President, Research and Development Zeus Scientific, Inc. P.O. Box 38 Raritan, NJ 08869

k042118 Re:

K042116
Trade/Device Name: AtheNA Multi-Lyte® EBV IgG Test System Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr virus serological reagents Regulatory Class: Class I Product Code: JRY Dated: March 22, 2005 Received: March 24, 2005

Dear Mr. Kopnitsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector b r (x), pe device is substantially equivalent (for the indications felerenced above and nave ustommed are are are and a sevices marketed in interstate for use stated in the encrosule) to regarly manatinent date of the Medical Device American Council Food. Days commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that to not require subject to the general controls provisions of the Act. The You may, therefore, manset the act include requirements for annual registration, listing of general controls provisions of the rest labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 a00 v) incl . Existing major regulations affecting your device in claim ca it may be subject to such additional controllar - Mating - CFFA), Parts 800 to 895. In addition, FDA call be found in Thic 21, Code of I concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issualled of a business with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has inade a decemination that your asseed by other Federal agencies. You must or any Pederal Statures and regulations annunities. but not limited to: registration and listing (21 comply with an the Are Frequire.netts 801 and 809); and good manufacturing practice CFR Part 807), labeling (21 OF RT List systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to ocgin maneeting your and equivalence of your device to a legally premarked notification: "The PDF intention for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements o your device, of for If you desire spectife information acour tising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may of all Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sales a Tory

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology 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): __K042118

Device Name:___AtheNA Multi-Lyte® EBV IgG Test System

Indications For Use:

The Zeus Scientific, Inc. AtheNA Multi-Lyte EBV IgG Test System is intended for the The Zeus Scientific, Inc. Athera Nitibedy to three separate EBV Antigens (EBV-VCA
qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA qualifative detection of IGG class antibody to through the AtheNA gg-1123, EBV-EA total and Coombinant LDN F be used with these EBV (gC markers)
Multi-Lyte System. The test system is intended to be used with these eigted Multi-Lyte System. The lest System is internation diagnosis of EBV-associated along with anti-EBV VOA igni to ald in the laberatory and caused by EBV virus.

Prescription Use _ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)________________________________________________________________________________________________________________________________________________________________________

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