(198 days)
The IBL Acetylcholine Receptor Antibody (ARAb) Radio Receptor Assay is for the in-vitrodiagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum and plasma.
The ARAb Assay kit is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG).
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to IBL-Hamburg GmbH regarding their IBL ARAb RRA Test Kit. This document formally approves the marketing of the device, stating it is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed study information, acceptance criteria, or performance data that would be required to answer the prompt.
Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC study details based only on the provided text.
The document primarily focuses on the regulatory aspects of the FDA's decision, such as:
- Device Name: IBL ARAb RRA Test Kit
- Regulation Number: 21 CFR 866.5660
- Regulation Name: Multiple autoantibodies immunological test system
- Regulatory Class: Class II
- Product Code: NST
- Indications For Use: The IBL Acetylcholine Receptor Antibody (ARAb) Radio Receptor Assay is for the in-vitro diagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum and plasma. The ARAb Assay kit is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG).
To provide the requested information, the actual 510(k) submission document, particularly the sections detailing the analytical and clinical performance studies, would be necessary.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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NOV 1 8 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
IBL-Hamburg GmbH c/o Mr. Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Road East Stroudsburg, PA 18301
Re: K051144
Trade/Device Name: IBL ARAb RRA Test Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: NST Dated: April 22, 2005 Received: May 6, 2005
Dear Mr. Lehnus:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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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, PAD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K051144
Device Name: IBL ARAb RRA test kit
Indications For Use:
The IBL Acetylcholine Receptor Antibody (ARAb) Radio Receptor Assay is for the in-vitrodiagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum and plasma.
The ARAb Assay kit is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG).
X Prescription Use (Part 21 CFR 801 Subpart D)
. . . .
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
chow
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Sately
510(k) K051144
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§ 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).