(235 days)
The QUANTA Lite™ CMV IgG ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quanitative 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.
Not Found
This document is a 510(k) clearance letter from the FDA for a diagnostic device, the QUANTA Lite™ CMV IgG ELISA Test Kit. It does not contain the acceptance criteria, device performance details, or information about a study that proves the device meets acceptance criteria.
The letter primarily:
- Acknowledges receipt and review of the 510(k) notification.
- States that the device is substantially equivalent to legally marketed predicate devices.
- Grants permission to market the device, subject to general controls.
- Provides information about regulatory classifications, additional controls, and relevant regulations.
- Instructs the applicant on how to determine CLIA complexity categorization.
- Includes the "Indications For Use" for the device, which describes what the test is designed to do (detect IgG antibodies to CMV in human serum for evaluating previous or primary infection) and specifies what it is not approved for (screening blood/plasma donors).
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document. The document is a regulatory approval, not a scientific study report or performance evaluation.
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DEC - 1 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Brys C. Mvers Manager, Regulatory Affairs Inova Diagnostics, Inc. 10451 Roselle Street San Diego, CA 92121
Re: K971335 Trade Name: Ouanta 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 (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 (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 vours.
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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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-quanitative 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 Ticerhurst MD, Interim (MICB) Branch Chief
(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)
§ 866.3175 Cytomegalovirus serological reagents.
(a)
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.(b)
Classification. Class II (performance standards).