QUANTA LITE CCP ELISA

K020414 · Inova Diagnostics, Inc. · NHX · Apr 29, 2002 · Immunology

Device Facts

• Record ID: K020414
• Device Name: QUANTA LITE CCP ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: NHX · Immunology
• Decision Date: Apr 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The QUANTA Lite™ CCP IgG ELISA is a semi-quantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP (Cyclic Citrullinated Peptide) antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis.

Device Story

QUANTA Lite™ CCP IgG ELISA is an in vitro diagnostic test used in clinical laboratories. It utilizes patient serum samples to detect IgG antibodies against Cyclic Citrullinated Peptide (CCP). The device operates via an enzyme-linked immunosorbent assay (ELISA) principle. Results are interpreted by laboratory professionals in conjunction with other clinical and laboratory findings to assist in the diagnosis of rheumatoid arthritis. The output provides a semi-quantitative measurement of anti-CCP antibodies, which aids clinicians in evaluating patients suspected of having rheumatoid arthritis.

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 the detection of IgG anti-CCP antibodies. The device is an in vitro diagnostic test kit. No specific materials, energy sources, or software algorithms are detailed in the provided text.

Indications for Use

Indicated for the semi-quantitative detection of IgG anti-CCP antibodies in human serum as an aid in the diagnosis of rheumatoid arthritis in patients presenting with clinical symptoms.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

ackvilla MD 7

Mr. Brys Myers Vice President INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131-1234

**APR 2 9 2002**

Re: k020414

> Trade/Device Name: QUANTA Lite™ CCP IgG ELISA Regulation Number: 21 CFR § 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: II Product Code: NHX Dated: April 11, 2002 Received: April 12, 2002

Dear Mr. Myers:

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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Nieu voël

Ning vout device as de 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/cdrb/dsma/dsmamain.html".

Sincerely yours.

Steven Butman

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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K020414

Indications for use statement

The QUANTA Lite™ CCP IgG ELISA is a semi-quantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP (Cyclic Citrullinated Peptide) antibodies in patient sera. The presence of these antibodies, when r optidered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis.

Sorsan S. Altare

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K020414

Perscription use