ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.

K051484 · Zeus Scientific, Inc. · LFY · Dec 5, 2005 · Microbiology

Device Facts

• Record ID: K051484
• Device Name: ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
• Applicant: Zeus Scientific, Inc.
• Product Code: LFY · Microbiology
• Decision Date: Dec 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3900
• Device Class: Class 2

Indications for Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte® VZV IgG Test System is a microparticle-based immunoassay intended for the quantitative detection of IgG class antibodies to Varicella-Zoster Virus in human serum. The AtheNA Multi-Lyte® VZV IgG Test System is intended for use as an aid in the assessment of a previous infection with Varicella-Zoster Virus.

Device Story

AtheNA Multi-Lyte® VZV IgG Test System is a microparticle-based immunoassay for quantitative detection of IgG antibodies to Varicella-Zoster Virus in human serum. Device used in clinical laboratory settings by trained personnel. Input is human serum sample; device utilizes microparticle technology to detect specific IgG antibodies. Output is quantitative measurement of VZV IgG levels, aiding clinicians in assessing patient's history of VZV infection. Results interpreted by healthcare providers to determine immune status or past exposure. Benefits include standardized, automated assessment of VZV serology.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Microparticle-based immunoassay; quantitative detection of IgG antibodies; serum-based testing; in vitro diagnostic reagent system.

Indications for Use

Indicated for the quantitative detection of IgG class antibodies to Varicella-Zoster Virus (VZV) in human serum to aid in the assessment of previous VZV infection.

Regulatory Classification

Identification

Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

2005 DEC 5

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

k051484 Re:

Trade/Device Name: AtheNA Multi – Lyte® VZV IgG Test System Regulation Number: 21 CFR 866.3900 Regulation Name: Varicella-zoster virus serological reagents Regulatory Class: Class II Product Code: LFY Dated: October 25, 2005 Received: October 31, 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 for associated in 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Driving and regulations administered by other Federal agencies. You must or any I 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) 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.

If you desire specific information about the application of labeling requirements to your device, 11 Jou don't op 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/industry/support/index.html

Sincerely yours,

Sales, a. Hogg

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): K051484

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

Indications For Use:

The Zeus Scientific, Inc. AtheNA Multi-Lyte® VZV IgG Test System is a microparticle-The Zeus Scientific, Inc. Atherw than Eyes in the United of IgG class based immunoassay intended for the quantative problem the AtheNA Multi-ation with arnious to Vancella 256tor Viras intelling of a previous infection with Varicella-Zoster 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)

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1484 510(k).