ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM

K042092 · Zeus Scientific, Inc. · LJN · Apr 12, 2005 · Microbiology

Device Facts

• Record ID: K042092
• Device Name: ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: LJN · Microbiology
• Decision Date: Apr 12, 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 VCA IgM Test System is a microparticle-based immunoassay intended for the qualitative detection of IgM class antibody to the Epstein-Barr virus, viral capsid antigen in human serum using the AtheNA Multi-Lyte® System. The test system is intended to be used for the laboratory diagnosis of EBV-associated infectious mononucleosis and provides epidemiological information on the diseases caused by Epstein-Barr virus.

Device Story

Microparticle bead-based immunoassay for qualitative detection of IgM antibodies to EBV-VCA in human serum; utilizes multiplexed polystyrene microspheres conjugated with EBV viral capsid antigen. Patient serum incubated with bead suspension; specific antibodies captured on antigen-coated beads. Phycoerythrin-conjugated goat anti-human IgM added as reporter; binding detected via flow cytometry on AtheNA Multi-Lyte instrument. Includes internal calibration beads and non-specific bead for invalidation of RF IgM-positive samples. Used in clinical laboratories; provides diagnostic information for infectious mononucleosis.

Clinical Evidence

Method comparison study of 763 specimens (693 prospective, 70 retrospective) against FDA-approved ELISA reference assays. Prospective acute sensitivity 96.0% (24/25), specificity 99.0% (575/581). Retrospective acute sensitivity 100% (48/48). Precision evaluated across three sites using six-member panel; SD and %CV reported for within-run and between-site variability. Analytical specificity tested against 30 specimens (other infectious agents, autoantibodies, RF IgM); RF IgM specimens correctly invalidated by internal control.

Technological Characteristics

Multiplexed bead-based immunoassay; polystyrene microspheres; phycoerythrin reporter conjugate; flow cytometry detection. Includes internal calibration beads and internal positive control (affinity purified human IgM). Software-based signal processing for fluorescence quantification and automated invalidation of non-specific reactive samples.

Indications for Use

Indicated for the laboratory diagnosis of EBV-associated infectious mononucleosis in patients suspected of having the infection. 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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APR 1 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K042092

Trade/Device Name: AtheNA Multi-Lyte® EBV VCA IgM Test System Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr virus serological reagents Regulatory Class: Class I Product Code: LJN Dated: February 9, 2005 Received: March 11, 2005

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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This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will anon you to substantial equivalence of your device of your device to a legally prarketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may overnial 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 Form

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): K042092

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Zeus Scientific, Inc. AtheNA Multi-Lyte® EBV VCA IgM Test System is a microparticle-based immunoassay intended for the qualitative detection of IgM class antibody to the Epstein-Barr virus, viral capsid antigen in human serum using the AtheNA Multi-Lyte® System. The test system is intended to be used for the laboratory diagnosis of EBV-associated infectious mononucleosis and provides epidemiological information on the diseases caused by Epstein-Barr 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)

Jack atz
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

KO42092 510(k)_

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