SERAQUEST CMV IGM

K982485 · Quest Intl., Inc. · LFZ · Jan 13, 1999 · Microbiology

Device Facts

• Record ID: K982485
• Device Name: SERAQUEST CMV IGM
• Applicant: Quest Intl., Inc.
• Product Code: LFZ · Microbiology
• Decision Date: Jan 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3175
• Device Class: Class 2

Intended Use

For the qualitative detection of IgM antibodies to CMV in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection. A positive result is presumptive for the detection of anti-CMV antibodies and presumptive for the diagnosis of acute or recent CMV infection. Useful for the above indications, with specimens obtained from women of childbearing age. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Device Story

SeraQuest CMV IgM is an enzyme immunoassay (EIA) for qualitative detection of IgM antibodies to Cytomegalovirus (CMV) in human serum. Used in clinical laboratories to aid in diagnosing CMV infection, particularly in women of childbearing age. Operates manually or via HyPrep System Plus semi-automated fluid handler. Provides qualitative results indicating presence of anti-CMV antibodies; assists clinicians in identifying acute or recent CMV infection. Results support clinical decision-making regarding patient management and infection status.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

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

Indications for Use

Indicated for qualitative detection of IgM antibodies to CMV in human serum to aid in diagnosis of CMV infection, specifically in women of childbearing age. Presumptive for acute or recent CMV infection.

Regulatory Classification

Identification

Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.

Reference Devices

• HyPrep System Plus

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 3 1999

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

K982485 Re: Trade Name: SeraQuest CMV IgM Regulatory Class: II Product Code: LFZ Dated: October 21, 1998 Received: October 26, 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 (OS) 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 Autman

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. jit

APPENDIX 7

1 of of 1 Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ر

Device Name: __SeraQuest CMV IgM

Indications For Use:

- For the qualitative detection of IgM antibodies to CMV in human serum by 1. enzyme immunoassay, to aid in the diagnosis of CMV infection.
- A positive result is presumptive for the detection of anti-CMV antibodies and 2. presumptive for the diagnosis of acute or recent CMV infection.
- Useful for the above indications, with specimens obtained from women of 3. childbearing age.
- For manual use, or for use with the HyPrep System Plus semi-automated fluid 4. handler.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woodley Dubois

(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K982485

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)