(139 days)
-
- For in vitro diagnostic use only.
-
- For the qualitative and semi-quantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum by enzyme immunoassay.
-
- Individual specimens may be used for the determination of immune status.
- Paired (acute / convalescent) sera, may be used to demonstrate seroconversion 4. or significant rises in antibody level, as an aid in the diagnosis of primary infection, or reactivation of VZV.
- For manual use, or for use with the HyPrep System Plus semi-automated fluid 5. handler.
Not Found
I am sorry, but based on the text provided, I cannot answer the request as there is no information about the acceptance criteria and study that proves the device meets the acceptance criteria. The text consists of a letter from the FDA regarding the 510(k) premarket notification for the SeraQuest VAV IgG device and its indications for use. It does not contain any details about performance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Robert A. Cort Vice President, Quality Assurance Quest International 1938 N.E. 148th Terrace North Miami, FL 33181
NOV - 5 1997
Product Code: LFY Dated: September 4, 1997 Received: September 8, 1997
Regulatory Class: II
Trade Name: SeraQuest VAV IgG
Dear Mr. Cort:
Re:
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 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 requirement, 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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Page 2
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 Sutman
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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Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 163
APPENDIX 11
Page 1 of of
510(k) Number (if known): ____________
Device Name: SeraQuest VZV IqG
Indications For Use:
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- For in vitro diagnostic use only.
-
- For the qualitative and semi-quantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum by enzyme immunoassay.
-
- Individual specimens may be used for the determination of immune status.
- Paired (acute / convalescent) sera, may be used to demonstrate seroconversion 4. or significant rises in antibody level, as an aid in the diagnosis of primary infection, or reactivation of VZV.
- For manual use, or for use with the HyPrep System Plus semi-automated fluid 5. handler.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tan Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_14 9702 95
Prescription Use _ し (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
. #278
(Optional Format 1-2-96)
§ 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).