ACETYLCHOLINE RECEPTOR AB (ARAB)RRA

K051144 · Ibl-Hamburg GmbH · NST · Nov 18, 2005 · Immunology

Device Facts

• Record ID: K051144
• Device Name: ACETYLCHOLINE RECEPTOR AB (ARAB)RRA
• Applicant: Ibl-Hamburg GmbH
• Product Code: NST · Immunology
• Decision Date: Nov 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended 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).

Device Story

In-vitro diagnostic radio receptor assay (RRA) for detection of acetylcholine receptor autoantibodies in human serum or plasma; aids in differential diagnosis of Myasthenia Gravis. Laboratory-based test; performed by trained technicians. Principle involves competitive binding; patient autoantibodies compete with labeled ligands for receptor sites. Output is semi-quantitative measurement of antibody levels. Results interpreted by clinicians to support clinical diagnosis of MG.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on bench testing and performance characteristics of the radio receptor assay.

Technological Characteristics

Radioreceptor immunoassay. Components: I125-labeled acetylcholine receptors, anti-human IgG antiserum, calibrators, wash buffer (PBS/Triton X100). Detection: Gamma counter. Matrix: Serum and plasma. Connectivity: Standalone. Software: None (manual calculation of standard curve).

Indications for Use

Indicated for the semi-quantitative determination of acetylcholine receptor autoantibodies in human serum and plasma to aid in the differential diagnosis of Myasthenia Gravis (MG).

Regulatory Classification

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).

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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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