QUANTA LITE CMV IGG ELISA

K971335 · Inova Diagnostics, Inc. · LFZ · Dec 1, 1997 · Microbiology

Device Facts

• Record ID: K971335
• Device Name: QUANTA LITE CMV IGG ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: LFZ · Microbiology
• Decision Date: Dec 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3175
• Device Class: Class 2

Intended Use

The QUANTA Lite™ CMV IgG ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

Device Story

Quanta Lite™ CMV IgG ELISA is an in vitro diagnostic test kit; utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect IgG antibodies to cytomegalovirus (CMV) in human serum samples. Performed in clinical laboratory settings by trained laboratory personnel. Input: human serum; process: antigen-antibody binding reaction; output: semi-quantitative measurement of CMV IgG antibodies. Results assist clinicians in determining patient serologic status regarding previous or primary CMV infection. Benefits include aiding in the diagnosis and management of CMV-related clinical conditions.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) kit for semi-quantitative detection of IgG antibodies. In vitro diagnostic device. No specific materials, software, or connectivity details provided.

Indications for Use

Indicated for semi-quantitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum to evaluate serologic evidence of previous or primary CMV infection. Not for screening blood or plasma donors.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
DEC - 1 1997

Brys C. Myers
Manager, Regulatory Affairs
Inova Diagnostics, Inc.
10451 Roselle Street
San Diego, CA 92121

Re: K971335
Trade Name: Quanta Lite™ CMV IgG ELISA
Regulatory Class: II
Product Code: LFZ
Dated: September 29, 1997
Received: October 1, 1997

Dear Mr. Myers:

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 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 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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Page 5 of 73

510(k) Number (if known): K971335

Device Name: QUANTA Lite™ CMV IgG ELISA Test Kit

K971²

## Indications For Use:

The QUANTA Lite™ CMV IgG ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

John Ticehurst MD, Interim (MICB) Branch Chief
11/26/97
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)