ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM

K063186 · Zeus Scientific, Inc. · LFX · Mar 21, 2007 · Microbiology

Device Facts

• Record ID: K063186
• Device Name: ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: LFX · Microbiology
• Decision Date: Mar 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Intended Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte Rubella IgG Test System is intended for the qualitative detection of IgG class antibody to Rubella virus in human sera by microparticle immunoassay testing on the AtheNA Multi-Lyte instrument. The results of the AtheNA Multi-Lyte Rubella IgG Test System may be used to determine the serological status of individuals including women of childbearing age. This test has been calibrated to the WHO International Standard for Rubella IgG at the cut-off. The magnitude of the test result above or below the cut-off does not correspond to International Units and is not indicative of total amount of antibody present.

Device Story

AtheNA Multi-Lyte Rubella IgG Test System is a microparticle immunoassay for qualitative detection of IgG antibodies to Rubella virus in human serum. Device operates on AtheNA Multi-Lyte Instrument; utilizes fluorescently labeled microparticles. Intended for clinical laboratory use to determine patient serological status. Output provides qualitative results relative to a cut-off calibrated to WHO International Standard. Results assist clinicians in assessing Rubella immunity status.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Microparticle sandwich immunoassay using polystyrene microspheres. Detection via phycoerythrin-conjugated goat anti-human IgG (Fc specific). Instrumentation: AtheNA Multi-Lyte system. Calibration: proprietary software-driven Intra-Well Calibration Technology using internal bead sets. Sample type: serum. Standard: NCCLS I/L6-A. Connectivity: requires AtheNA Multi-Lyte instrument and software.

Indications for Use

Indicated for the qualitative detection of IgG antibodies to Rubella virus in human serum to aid in the assessment of immune status to Rubella virus. For professional use.

Regulatory Classification

Identification

Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards': (i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,” (ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,” (iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,” (iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and (v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,” (2) Centers for Disease Control's: (i) Low Titer Rubella Standard, (ii) Reference Panel of Well Characterized Rubella Sera, and (3) World Health Organization's International Rubella Standard.

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 and Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

FEB 1 9 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Zeus Scientific, Inc. C/O Ewa Nadolczak Manager, Clinical Affairs 200 Evans Way Branchburg, NJ 08876

Re: K063186

Trade/Device Name: AtheNA Multi-Lyte Rubella IgG Test System Regulation Number: 21 CFR 866.3510 Regulation Name: Rubella Virus Serological Reagents Regulatory Class: II Product Code: LFX Dated: February 26, 2007 Received: March 2, 2007

Dear Ms. Nadolczak:

This letter corrects our substantially equivalent letter of March 21, 2007.

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 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

## Uwe Scherf -S for

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known):

Device Name: AtheNA Multi-Lyte® Rubella IgG Test System

Indications For Use:

The Zeus Scientific, Inc. AtheNA Multi-Lyte Rubella IgG Test System is intended for the qualitative detection of IgG class antibody to Rubella virus in human sera by microparticle immunoassay testing on the AtheNA Multi-Lyte Instrument. The results of the AtheNA Multi-Lyte Rubella IgG Test System may be used to determine the serological status of individuals including women of childbearing age.

This test has been calibrated to the WHO International Standard for Rubella IgG at the cut-off. The magnitude of the test result above or below the cut-off does not correspond to International Units and is not indicative of total amount of antibody present.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Jay act
**Division Sign-Off**

Office of in Vitro Diagnostic Device Evaluation and Safety

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