DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

K021516 · Axis-Shield Diagnostics, Ltd. · NHX · Jul 23, 2002 · Immunology

Device Facts

• Record ID: K021516
• Device Name: DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
• Applicant: Axis-Shield Diagnostics, Ltd.
• Product Code: NHX · Immunology
• Decision Date: Jul 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The Diastat™Anti-CCP test is a semi-quantitative/ qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum. It is intended to aid in the diagnosis of Rheumatoid Arthritis (RA) and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.

Device Story

The Diastat™ Anti-CCP ELISA is an in vitro diagnostic test used in clinical laboratories. It utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect IgG autoantibodies against cyclic citrullinated peptide in human serum samples. The device provides semi-quantitative or qualitative results, which clinicians use as one component of a multi-criterion diagnostic process for Rheumatoid Arthritis. By identifying specific autoantibodies, the test assists healthcare providers in confirming or supporting a clinical diagnosis of RA, facilitating earlier or more accurate patient management.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for detection of IgG autoantibodies. Class II device, product code NHX, regulated under 21 CFR 866.5775.

Indications for Use

Indicated for the detection of IgG class autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum to aid in the diagnosis of Rheumatoid Arthritis (RA). Not for use as a definitive diagnostic test in isolation.

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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUL 2 3 2002

Ms. Eileen McCafferty Regulatory Affairs Manager Axis-Shield Diagnostics Limited Luna Place The Technology Park Dundee DD2 1XA SCOTLAND

Re: k021516

> Trade/Device Name: DIASTAT™ Anti-Cyclic Citrullinated Peptide (anti-CCP) ELISA Regulation Number: 21 CFR § 866.5775 Regulation Name: Rheumatoid Factor Immunological Test system Regulatory Class: II Product Code: NHX Dated: May 8, 2002 Received: May 10, 2002

Dear Ms. McCafferty:

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.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".

Sincerely vours.

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) number if known:

Device Name: Diastat™Anti-Cyclic Citrullinated Peptide (anti-CCP) ELISA

Indications for Use: The Diastat™Anti-CCP test is a semi-quantitative/ qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum. It is intended to aid in the diagnosis of Rheumatoid Arthritis (RA) and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.

H. Reeves for S. Altaie

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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