QUANTA FLASH H-TTG IGG

K101644 · Inova Diagnostics, Inc. · MVM · Mar 23, 2011 · Immunology

Device Facts

• Record ID: K101644
• Device Name: QUANTA FLASH H-TTG IGG
• Applicant: Inova Diagnostics, Inc.
• Product Code: MVM · Immunology
• Decision Date: Mar 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The QUANTA Flash h-tTG IgG is a chemiluminescent immunoassay (CIA) for the semi-quantitative detection of IgG anti-human tissue transglutaminase (h-ITG) antibodies in human serum. The presence of IgG anti-h-tTG antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of the gluten sensitive enteropathy celiac disease, particularly in patients with selective IgA deficiency. The QUANTA Flash™ h-tTG IgG Calibrators are intended for use with the QUANTA Flash™ h-tTG IgG chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used to determine values in the measurement of IgG anti-h-tTG antibodies in serum. The QUANTA Flash™ h-tTG IgG Controls are intended for quality control purposes of the QUANTA Flash™ h-tTG IgG chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument.

Device Story

QUANTA Flash h-tTG IgG is a chemiluminescent immunoassay (CIA) for detecting IgG anti-h-tTG antibodies in human serum. Used on the BIO-FLASH instrument; operated by laboratory professionals in clinical settings. Device utilizes calibrators to establish a working curve and controls for quality assurance. Output is a semi-quantitative measurement of IgG anti-h-tTG antibodies. Results assist clinicians in diagnosing celiac disease, particularly in patients with selective IgA deficiency, when combined with other clinical and laboratory findings.

Clinical Evidence

Clinical validation included 368 samples (48 CD, 320 non-CD). Sensitivity 50.0% (95% CI: 35.2-64.8%); Specificity 98.4% (95% CI: 96.4-99.5%). Method comparison with predicate (n=111) showed 90.2% positive agreement and 100% negative agreement. Analytical performance included precision (total CV 6.6-8.6%), linearity (R2 0.93-1.00), and LoD (1.7 CU).

Technological Characteristics

Chemiluminescent immunoassay (CIA) using paramagnetic beads coated with recombinant human tissue transglutaminase. Detection via isoluminol-conjugated monoclonal anti-human IgG. Instrument-based (BIO-FLASH™) with automated wash/incubation cycles. Signal measured as RLU. Reagents include sodium azide/chloramphenicol preservatives. Calibration uses lot-specific 4-parameter logistic curve stored in reagent barcode.

Indications for Use

Indicated for the semi-quantitative detection of IgG anti-human tissue transglutaminase (h-tTG) antibodies in human serum to aid in the diagnosis of celiac disease, particularly in patients with selective IgA deficiency. For prescription use only.

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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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

INOVA Diagnostics, Inc. c/o Rufus Burlingame, Ph.D. Director, Technology and Development 9900 Old Grove Road San Diego, CA 92131

MAR 2 3 2011

Re: k101644

Trade/Device Name: QUANTA Flash™ h-tTG IgG QUANTA Flash™ h-tTG IgG Calibrators QUANTA Flash™ h-tTG IgG Controls Regulation Number: 21CFR§866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Codes: MVM, JIX, JJX Dated: March 15, 2011 Received: March 15, 2011

Dear Dr. Burlingame:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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

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Page 2 - Rufus Burlingame, Ph.D.

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as 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 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 Parts 801 and 809), 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). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 vours.

ia m. chan

Maria M. Chan, 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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## Indications for Use

510(k) Number (if known): k101644

Device Name:_QUANTA Flash™:h-tTG IgG

Indications For Use:

The QUANTA Flash h-tTG IgG is a chemiluminescent immunoassay (CIA) for the semi-quantitative detection of IgG anti-human tissue transglutaminase (h-ITG) antibodies in human serum. The presence of IgG anti-h-tTG antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of the gluten sensitive enteropathy celiac disease, particularly in patients with selective IgA deficiency.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Reena Philip
Division Sign-Off

Division Sign-C

Office of In Vitro Diagno Device Evaluation and St

510K K101644

Page 1 of __3_

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## Indications for Use

510(k) Number (if known): K101644

## Device Name:_QUANTA Flash™ h-tTG IgG Calibrators

Indications For Use:

The QUANTA Flash™ h-tTG IgG Calibrators are intended for use with the QUANTA Flash™ h-tTG IgG chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used to determine values in the measurement of IgG anti-h-tTG antibodies in serum.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Reena Philip
Division Sign-Off

Division Sign-O

Office of In Vitro Diagnostic Device Evaluation and Safety

S10K K101644

Page 2 of ____________________________________________________________________________________________________________________________________________________________________

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## Indications for Use

510(k) Number (if known): k101644

Device Name:_QUANTA Flash™ h-tTG IgG Controls

Indications For Use:

The QUANTA Flash™ h-tTG IgG Controls are intended for quality control purposes of the QUANTA Flash™ h-tTG IgG chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Reena Philip

Division Sign-Off

Office of In Vitro Diagn Device Evaluation and

510K K101644

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