(553 days)
This assay is designed for the in vitro measurement of human IgG3 in serum using the MININEH analyzer as measurement of human 1965 in berail ablig one and in the diagnosis of the
Not Found
The provided text is a 510(k) clearance letter from the FDA for "IgG and IgG Subclass Nephelometric Diagnostic Test Kits" (Trade Name: Minineph IgG3 Antiserum Device Name). It confirms the device's substantial equivalence to a legally marketed predicate device.
However, this document does not contain the detailed acceptance criteria and study data requested in your prompt.
The letter focuses on regulatory clearance, not the technical specifications, performance data, or study methodologies that would typically be found in a 510(k) summary, clinical study report, or a more comprehensive technical document. It mentions that the device is for "in vitro measurement of human IgG3 in serum using the MININEPH analyzer."
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, reported performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The eagle is composed of three human profiles facing the same direction. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 0 1999
The Binding Site, Limited C/O Mr. Jay H. Geller East Tower, Suite 600 2425 West Olympic Boulevard Santa Monica, California 90404
K982100 Trade Name: IgG and IgG Subclass Nephelometric Diagnostic Test Kits Regulatory Class: II Product Code: CFN Dated: October 14, 1999 Received: October 15, 1999
Dear Mr. Geller:
Re:
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 (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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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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INDICATIONS FOR USE STATEMENT
Minineph IgG3 Antiserum Device Name:
This assay is designed for the in vitro Indications for Use: This assay is designed for the in xitro
measurement of human IgG3 in serum using the MININEH analyzer as measurement of human 1965 in berail ablig one and in the diagnosis of the
Peter C. Mafani
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number __
Penouplini-✓
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).