(125 days)
An indirect immunofluorescence assay (IFA) for the detection of and semi-quantitation of endomysial antibodies (EMA) in human serum to aid in the diagnosis of Celiac Disease (CD) and Dermatitis Herpetiformis (DH) in combination with other clinical and other laboratory findings.
An indirect immunofluorescence assay (IFA) for the detection of and semi-quantitation of endomysial antibodies (EMA) in human serum.
The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications.
The letter acknowledges the device's substantial equivalence to a predicate device and states its intended use, but it does not include the results of performance studies that would typically be found in the 510(k) summary or the full submission.
Therefore, I cannot provide the requested information from the given text.
If you have access to the actual 510(k) submission (K060157), specifically the "Device Description," "Performance Characteristics," or "Summary of Nonclinical and/or Clinical Studies" sections, that is where you would find the details needed to answer your questions.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular fashion around the eagle.
Public Health Service
MAY 2 5 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
IMMCO Diagnostics, Inc. c/o Mr. Kevin Lawson Director of Regulatory Affairs 60 Pineview Drive Buffalo, New York 14228-2120
Re: K060157
Trade/Device Name: ImmGlo Anti-Endomysial Antibody IFA Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MVM Dated: May 8, 2006 Received: May 9, 2006
Dear Mr. Lawson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
{1}------------------------------------------------
Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PA Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K060157
Device Name:
ImmuGlo Anti-Endomysial Antibody IFA
Indications For Use:
An indirect immunofluorescence assay (IFA) for the detection of and semi-quantitation of endomysial antibodies (EMA) in human serum to aid in the diagnosis of Celiac Disease (CD) and Dermatitis Herpetiformis (DH) in combination with other clinical and other laboratory findings.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
m chen
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
562(2) K
$$_{6}$$
(0157
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).