(82 days)
The QUANTA Lite TM Rubeola (Measles) IgG ELISA System is designed for the qualitative determination of IgG antibodies to rubeola (measles) in human serum from adult, neonate, and immunocompromised patients. The test system is intended to be used to evaluate serologic evidence of previous infection with rubeola (measles) and as an aid in the diagnosis of rubeola (measles) infection.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain information regarding detailed acceptance criteria, study design parameters, or performance data beyond the device's intended use. Therefore, I cannot extract the specific information requested in the prompt based on the provided document.
To answer your request, I would need a document that describes the premarket notification submission in detail, including the study protocols, results, and acceptance criteria.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 2 1997
Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10451 Roselle Street San Diego, CA 92121
Re: K971620
Trade Name: Quanta Lite Rubeola (Measles) IgG Regulatory Class: I Product Code: LJB Dated: April 30, 1997 Received: May 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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
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510(k) Number (if known):
Device Name: QUANTA Lite™ Rubeola (Measles) IgG BLISA Teat Kit
Indications For Use:
The QUANTA Lite TM Rubeola (Measles) IgG ELISA System is designed for the qualitative determination of IgG antibodies to rubeola (measles) in human serum from adult, neonate, and immunocompromised patients. The test system is intended to be used to evaluate serologic evidence of previous infection with rubeola (measles) and as an aid in the diagnosis of rubeola (measles) infection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ale Puh
(Division Sign-Off) Division of Clinica! Laboratory Devices
510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
OR _ .
Over-The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 866.3520 Rubeola (measles) virus serological reagents.
(a)
Identification. Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.