IVD TECHNOLOGIES ACHRAB TEST KIT

K091468 · Ivd Technologies · NST · Nov 20, 2009 · Immunology

Device Facts

• Record ID: K091468
• Device Name: IVD TECHNOLOGIES ACHRAB TEST KIT
• Applicant: Ivd Technologies
• Product Code: NST · Immunology
• Decision Date: Nov 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The AchRAb Assay is a radioimmunoassay for the in vitro diagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum. The AchRAb assay is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG) in conjunction with other clinical and laboratory findings.

Device Story

The AchRAb Assay is a radioimmunoassay (RIA) used in clinical laboratories to detect autoantibodies against the acetylcholine receptor in human serum. The device utilizes human acetylcholine receptors labeled with 125I-α-bungarotoxin. Patient serum is incubated with the labeled receptor; autoantibodies present in the sample bind to the receptor to form complexes. These complexes are immunoprecipitated using goat anti-human IgG and centrifuged. The resulting pellet is measured in a gamma counter. The radioactivity count is directly proportional to the concentration of autoantibodies in the sample. Results are calculated against a standard curve to provide a semi-quantitative value. The assay aids clinicians in the differential diagnosis of Myasthenia Gravis by identifying elevated antibody titers (≥ 0.5 nmol/L).

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Radioimmunoassay (RIA) utilizing 125I-labeled α-bungarotoxin. Components include lyophilized human acetylcholine receptor, 125I-AchR diluent (Tris buffer, surfactant), 6-level standards, positive/negative controls, goat anti-human IgG, and wash buffer. Detection requires a gamma counter. Assay range: 0.1–7.5 nmol/L. Functional sensitivity: 0.1 nmol/L.

Indications for Use

Indicated for the semiquantitative determination of acetylcholine receptor autoantibodies in human serum 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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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

**NOV** 20 2009
NC:

IVD Technologies, Inc. c/o Mr. Gary Lehnus Lehnus & Associates consulting 150 Cherry Lane Road East Stroudsburg, PA 18301

Re: k091468

Trade/Device Name: AchRAb Acetycholine Receptor Ab Kit Regulation Number: 21 CFR §866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: NST Dated: October 08, 2009 Received: October 15, 2009

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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems

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Page 2 – Mr. Gary Lehnus

(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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ia m chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices 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): K091468

Device Name: IVD Technologies AChRAb test kit

Indications For Use:

The AChRAb Assay is a radioimmunoassay for the in-vitro-diagnostic semiquantitative determination of autoantibodies against the acetylcholine receptor in human serum.

The AChRAb assay is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG) in conjunction with other clinical and laboratory findings.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Prescription Use × (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Maria In Chen

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

510(k) Ko9 1468