SERAQUEST MUMPS IGG

K980059 · Quest Intl., Inc. · LJY · Apr 23, 1998 · Microbiology

Device Facts

• Record ID: K980059
• Device Name: SERAQUEST MUMPS IGG
• Applicant: Quest Intl., Inc.
• Product Code: LJY · Microbiology
• Decision Date: Apr 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3380
• Device Class: Class 1

Intended Use

For in vitro diagnostic use only. For the qualitative and semi-quantitative detection of IgG antibodies to mumps virus 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. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Device Story

SeraQuest Mumps IgG is an enzyme immunoassay (EIA) for detection of IgG antibodies to mumps virus in human serum. Device used in clinical laboratory settings; operated by laboratory personnel. Input: human serum samples. Principle: enzyme immunoassay; detects presence/level of mumps-specific IgG. Output: qualitative or semi-quantitative antibody results. Results used by clinicians to assess patient immune status or aid in diagnosis of primary mumps infection. Can be performed manually or using HyPrep System Plus semi-automated fluid handler.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory classification and intended use.

Technological Characteristics

Enzyme immunoassay (EIA) for detection of IgG antibodies. Compatible with manual processing or 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 mumps virus in human serum to determine immune status or aid in diagnosis of primary infection via seroconversion or antibody level rise in paired sera.

Regulatory Classification

Identification

Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.

Reference Devices

• HyPrep System Plus

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## APR 2 3 1998

Robert A. Cort Vice President, Quality Assurance Ouest International, Inc. 1938 N.E. 148th Terrace North Miami, FL 33181

K980059 Re: Trade Name: SeraQuest Mumps IgG Regulatory Class: I Product Code: LJY Dated: March 6, 1998 Received: March 9, 1998

## Dear Mr. Cort:

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 [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 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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Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No.

## APPENDIX 10

Page -

K 980059 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: SeraQuest Mumps IgG

Indications For Use:

- 1. For in vitro diagnostic use only.
- 2. For the qualitative and semi-quantitative detection of IgG antibodies to mumps virus in human serum by enzyme immunoassay.
- റ്റ് Individual specimens may be used for the determination of immune status.
- 4. 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.
- 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)

4/21/98
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K980059

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)