SERAQUEST VZV IGG

K972295 · Quest Intl., Inc. · LFY · Nov 5, 1997 · Microbiology

Device Facts

• Record ID: K972295
• Device Name: SERAQUEST VZV IGG
• Applicant: Quest Intl., Inc.
• Product Code: LFY · Microbiology
• Decision Date: Nov 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3900
• Device Class: Class 2

Intended Use

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 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 handler.

Device Story

SeraQuest VZV IgG is an enzyme immunoassay (EIA) for detecting IgG antibodies to varicella zoster virus in human serum. The device processes serum samples to identify immune status or seroconversion/antibody titer increases indicative of VZV infection or reactivation. It is designed for manual laboratory use or integration with the HyPrep System Plus semi-automated fluid handler. Healthcare providers use the qualitative or semi-quantitative results to assess patient immunity or confirm clinical suspicion of VZV infection, facilitating appropriate patient management and diagnostic decision-making.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme immunoassay (EIA) for antibody detection. Compatible with manual processing or the HyPrep System Plus semi-automated fluid handler. In vitro diagnostic device.

Indications for Use

Indicated for qualitative and semi-quantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum. Used for determining immune status and as an aid in diagnosing primary infection or reactivation of VZV via paired acute/convalescent sera analysis.

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.

Reference Devices

• HyPrep System Plus

Submission Summary (Full Text)

{0}------------------------------------------------

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

K972295

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.

{1}------------------------------------------------

## 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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

{2}------------------------------------------------

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:

- 1. For in vitro diagnostic use only.
- 2. For the qualitative and semi-quantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum by enzyme immunoassay.
- 3. 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)