QUANTA LITE CCP3 IGG ELISA

K052264 · Inova Diagnostics, Inc. · NHX · Nov 23, 2005 · Immunology

Device Facts

• Record ID: K052264
• Device Name: QUANTA LITE CCP3 IGG ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: NHX · Immunology
• Decision Date: Nov 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The QUANTA Lite™ CCP3 IgG ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP3 (Cyclic Citrullinated Peptide 3) antibodies in patient sera or citrated or EDTA plasma. 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™ CCP3 IgG ELISA is an in vitro diagnostic test; utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect IgG antibodies against Cyclic Citrullinated Peptide 3 (CCP3) in patient blood samples (sera, citrated plasma, or EDTA plasma). Performed in clinical laboratory settings by trained personnel. Input: patient blood sample; Output: semiquantitative measurement of anti-CCP3 IgG antibodies. Results assist clinicians in diagnosing rheumatoid arthritis when combined with other clinical/laboratory data. Device provides objective immunological data to support clinical decision-making.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on bench testing and regulatory review of the ELISA methodology.

Technological Characteristics

ELISA; polystyrene microwell plate coated with synthetic CCP3 antigen; colorimetric detection using HRP conjugate and TMB substrate; spectrophotometric readout; semi-quantitative; manual or automated plate reader required; serum/EDTA plasma samples.

Indications for Use

Indicated for the detection of IgG anti-CCP3 antibodies in human serum, citrated plasma, or EDTA plasma to aid in the diagnosis of rheumatoid arthritis in conjunction with other clinical and laboratory findings.

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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Public Health Service

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INOVA Diagnostics, Inc. c/o Mr. Brys C. Myers Vice President 9900 Old Grove Rd. San Diego, CA 92131-1638

NOV 2 3 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k052264

Trade/Device Name: QUANTA Lite™ CCP3 IgG ELISA Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: Class II Product Code: NHX Dated: August 18, 2005 Received: August 19, 2005

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 (OS) 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,

Robert Beckerh

Robert L. Becker, Jr., MD, PH.D 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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## 510(k) Number (if known): K052264

## Device Name: QUANTA Lite™ CCP3 IgG ELISA

## Indications For Use:

The QUANTA Lite™ CCP3 IgG ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP3 (Cyclic Citrullinated Peptide 3) antibodies in patient sera or citrated or EDTA plasma. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis.

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

Concurrence of CDRH, Office of Device Evaluation

(ODE)

Maria Chan

**Division Sign-Off**

Prescription Use_X_ Use (Per 21 CFR 801.109)

Office of In Vitro Diagnostic
Device Evaluation and Over-The-Counter

510(K) K052204

(Optional Format 1-2-96)