(60 days)
The VZV IgG ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus), qualitative determination of IgG-class antibody to VZV in human serum. The test is intended to be used to aid in the determiation of immune status, and/or aid in the diagnosos of VZV infections, and is for in vitro diagnostic use.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Aptus (automated) Application for the VZV IgG ELISA Test System". This document grants clearance based on substantial equivalence to a predicate device and describes the intended use of the device, but it does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance, not the specifics of the clinical study that would have supported the 510(k) submission.
To answer your questions, I would need access to the actual 510(k) submission document or a summary of the clinical study, which are not provided in the given text.
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Public Health Service
JAN 22 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark J. Kopnitsky Vice President, Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, NJ 08876
Re: K984181
Trade Name: The Aptus (automated) Application for the VZV IgG ELISA Test System Regulatory Class: II Product Code: LFY Dated: November 19, 1998 Received: November 23, 1998
Dear Mr. Kopnitsky:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Y98 Yl 8/
Aptus (automated) Application for the VZV IgG ELISA Test Device Name: System
Indications for Use:
The VZV IgG ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus), qualitative determination of IgG-class antibody to VZV in human serum. The test is intended to be used to aid in the determiation of immune status, and/or aid in the diagnosos of VZV infections, and is for in vitro diagnostic use.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801,109) | (Optional Format 1- | ||
| 2-96) |
Woody Dubois
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K984181
§ 866.3900 Varicella-zoster virus serological reagents.
(a)
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.(b)
Classification. Class II (performance standards).