QUANTA PLEX CELIAC IGA PROFILE

K063818 · Inova Diagnostics, Inc. · MVM · Jun 20, 2007 · Immunology

Device Facts

• Record ID: K063818
• Device Name: QUANTA PLEX CELIAC IGA PROFILE
• Applicant: Inova Diagnostics, Inc.
• Product Code: MVM · Immunology
• Decision Date: Jun 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The QUANTA Plex™ Celiac IgA Profile is a fluorescent immunoassay for the semi-quantitative detection of IgA anti-human tissue transglutaminase (htTG) and antideamidated gliadin peptide (DGP) antibodies, and the detection of an insufficient amount of IgA, in human serum. The presence of these antibodies in conjunction with other laboratory and clinical findings is an aid in the diagnosis of the gluten sensitive enteropathy celiac disease. Insufficient IgA indicates that there is not enough IgA to allow detection of IgA anti-htTG or anti-DGP.

Device Story

QUANTA Plex™ Celiac IgA Profile is a fluorescent immunoassay; detects IgA anti-htTG and anti-DGP antibodies plus total IgA levels in human serum. Used in clinical laboratory settings by trained personnel. Input: human serum samples. Principle: immunoassay-based detection of specific autoantibodies. Output: semi-quantitative results for antibodies and assessment of IgA sufficiency. Results assist clinicians in diagnosing celiac disease when combined with other clinical and laboratory findings. Benefits patients by providing diagnostic aid for gluten-sensitive enteropathy.

Clinical Evidence

Clinical study evaluated 523 samples (29 active celiac disease, 494 non-celiac). For anti-htTG IgA: 93.1% sensitivity, 97.8% specificity. For anti-DGP IgA: 65.5% sensitivity, 97.6% specificity. Method comparison against predicate ELISAs (n=954) showed 97.6% overall agreement for anti-htTG and 96.3% for anti-DGP. Analytical specificity testing (n=63) showed no cross-reactivity with RF, anti-CCP, ANA, or various infectious disease markers.

Technological Characteristics

Semi-quantitative multiplexed fluorescent immunoassay. Components: polystyrene microwell plates, four color-coded antigen/antibody-coated microspheres (htTG, DGP, anti-IgA, IgA). Detection: fluorescent-labeled goat anti-human IgA conjugate. Platform: Luminex 100/200 flow analyzer. Software: Luminex Integrated System (IS). No washing steps required. Dynamic range: 20 to >20,000 FU.

Indications for Use

Indicated for use as an aid in the diagnosis of celiac disease in patients with sufficient IgA and for the identification of IgA-deficient patients.

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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

INOVA Diagnostics, Inc. c/o Mr. Brys Myers Vice President 9900 Old Grove Road San Diego, CA 92131-1234

JUN 2 0 2007

Re: k063818

Trade/Device Name: QUANTA Plex™ Celiac IgA Profile Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM. MST Dated: June 13, 2007 Received: June 13, 2007

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.org set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The

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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 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" (21 CFR 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 Becker

Robert L. Becker, Jr., M.D., 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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# 510(k) Number (if known):_长0638/8

### Device Name: QUANTA Plex™ Celiac IgA Profile

## Indications For Use:

The QUANTA Plex™ Celiac IgA Profile is a fluorescent immunoassay for the semi-quantitative detection of IgA anti-human tissue transglutaminase (htTG) and antideamidated gliadin peptide (DGP) antibodies, and the detection of an insufficient amount of IgA, in human serum. The presence of these antibodies in conjunction with other laboratory and clinical findings is an aid in the diagnosis of the gluten sensitive enteropathy celiac disease. Insufficient IgA indicates that there is not enough IgA to allow detection of IgA anti-htTG or anti-DGP.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use X Use (Per 21 CFR 801.109) 2-96

Over-The Counter

(Optional Format 1-

Maria McLen
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safe:

510(k) 063818