IMMUNOSCAN RA ANTI-CCP TEST SYSTEM

K052133 · Eurodiagnostica · NHX · Dec 12, 2005 · Immunology

Device Facts

• Record ID: K052133
• Device Name: IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
• Applicant: Eurodiagnostica
• Product Code: NHX · Immunology
• Decision Date: Dec 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The Immunoscan RA anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals.

Device Story

Immunoscan RA anti-CCP test kit is an ELISA-based in vitro diagnostic assay; detects IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum samples. Performed by trained laboratory professionals in clinical laboratory settings. Input: single serum specimen. Process: enzyme-linked immunosorbent assay; semi-quantitation of antibody levels. Output: semi-quantitative result used by clinicians as an aid in diagnosing Rheumatoid Arthritis (RA) alongside other clinical and laboratory findings. Benefits: assists in early or differential diagnosis of RA.

Clinical Evidence

No clinical data provided in the summary document; relies on bench testing and performance validation of the ELISA assay.

Technological Characteristics

ELISA-based immunoassay; 96-well microtiter plate format. Antigen: purified citrullinated synthetic peptides. Detection: HRP-labeled anti-human IgG conjugate with TMB substrate. Energy source: photometric measurement at 450 nm. Requires microplate reader and washer. Qualitative and semi-quantitative output.

Indications for Use

Indicated for the detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum as an aid in the diagnosis of Rheumatoid Arthritis (RA). For use by trained laboratory professionals.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The logo is presented in black and white.

Eurodiagnostica c/o Mr. William L. Boteler Jr. Immuno Probe, Inc. 1306 Bailes Lane, Suite F Frederick, MD 21701

DEC I 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k052133

Trade/Device Name: Immunoscan RA anti-CCP Test Kit Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: Class II Product Code: NHX Dated: August 4, 2005 Received: August 5, 2005

Dear Mr. Boteler:

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.

{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 [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, PJ Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page 1 of 1

510(k) Number: K052133

Device Name: Immunoscan RA anti-CCP Test Kit

Indications For Use: The Immunoscan RA anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) [\]; [\] ]
------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

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

Maria Chan

Jivision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

10(k)_________________________________________________________________________________________________________________________________________________________________________