(60 days)
This assay is intended for the in-vitro measurement of specific IgG, IgA and IgM autoantibodies against mitochondria present in human serum as an aid in the diagnosis of primary biliary cirrhosis (PBC) when used in conjunction with other clinical observations.
BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit
The provided text describes a 510(k) premarket notification for the "BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit." This document is a regulatory letter from the FDA determining substantial equivalence, and it does not contain the detailed study results, acceptance criteria, or performance data typically found in a clinical study report.
Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document primarily states:
- Device Name: BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit
- Intended Use: "This assay is intended for the in-vitro measurement of specific IgG, IgA and IgM autoantibodies against mitochondria present in human serum as an aid in the diagnosis of primary biliary cirrhosis (PBC) when used in conjunction with other clinical observations."
- Regulatory Status: Substantially equivalent to a legally marketed predicate device.
- Product Code: DBM (Anti-mitochondrial antibody immunological test system)
- Regulatory Class: Class II
To provide the information you requested, access to the actual 510(k) submission document or a clinical study report would be necessary.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 4 2003
The Binding Site, Ltd. c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, CA 90404
Re: K030238
Trade/Device Name: BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit Regulation Number: 21 CFR 866.5090 Regulation Name: Anti-mitochondrial antibody immunological test system Regulatory Class: Class II Product Code: DBM Dated: January 20, 2003 Received: January 23, 2003
Dear Mr. Geller:
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, 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 (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 your 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).
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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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page of of
510(k) Number (if known): KO30238
Device Name: BINDAZYME Anti - Mitochordria M2 Ig GAM EIA
Indications For Use:
INDICATIONS FOR USE STATEMENT
BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit Device Name:
This assay is intended for the in-vitro Indications for Use: of specific IgG, IgA and IgM autoantibodies against measurement mitochondria present in human serum as an aid in the diagnosis of primary biliary cirrhosis (PBC) when used in conjunction with other clinical observations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Reeves for J. Bautista
Division of Clinical Laboratory Devices
510(k) Number_1 CO >
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 866.5090 Antimitochondrial antibody immunological test system.
(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).