IGX PLEX CELIAC QUALITATIVE ASSAY

K102490 · Sqi Diagnostics Systems · MVM · Jun 2, 2011 · Immunology

Device Facts

• Record ID: K102490
• Device Name: IGX PLEX CELIAC QUALITATIVE ASSAY
• Applicant: Sqi Diagnostics Systems
• Product Code: MVM · Immunology
• Decision Date: Jun 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The IgX plex™ Celiac Qualitative Assay is an in vitro diagnostic test for the qualitative detection of the IgA and IgG immunoglobulin classes of anti-tissue transglutaminase antibody in serum. The test is intended for use in clinical laboratories as an aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.

Device Story

The IgX PLEX Celiac Qualitative Assay is a multiplex immunoassay performed on the SQiDworks Diagnostics Platform. The device uses microarray plates with immobilized recombinant human tissue-transglutaminase (tTG) to capture anti-tTG IgA and IgG antibodies from patient serum. After washing, fluorescently labeled anti-human IgA and IgG antibodies are added as a reporter mix. The platform automates the entire process, including sample pipetting, dilution, incubation, washing, and drying. The instrument performs a multicolor fluorescent scan of the microarray, analyzes the signal intensity, and generates qualitative results for each analyte. Used in clinical laboratories by trained personnel, the device provides automated diagnostic support to clinicians, aiding in the identification of celiac disease. The system includes internal quality checks and safety interlocks.

Clinical Evidence

Clinical study evaluated performance against predicate systems. Results: anti-tTG-IgA sensitivity 98.3%, specificity 94.5%; anti-tTG-IgG sensitivity 80.9%, specificity 89.0%. Reproducibility 92.4-100% (IgA) and 95.8-100% (IgG). Overall agreement with predicates: 89.3% (IgA) and 85.1% (IgG). No interference observed from bilirubin, hemoglobin, triglycerides, or human IgG.

Technological Characteristics

Microarray-based multiplex immunoassay. Components: 96-well plates with covalently bound recombinant human tTG capture spots. Detection: Fluorescently labeled mouse monoclonal anti-human IgA/IgG antibodies. Energy: Automated platform (SQiDworks) for fluidics and multicolor fluorescent scanning. Connectivity: Standalone instrument. Software: Automated analysis of fluorescent signal intensity against analyte-specific cut-offs (2.8 U/mL for IgA, 4.9 U/mL for IgG).

Indications for Use

Indicated for use as an aid in the diagnosis of celiac disease in patients suspected of having the condition, utilizing serum samples. Requires prescription use.

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).

Predicate Devices

• Aeskulisa™ tTG-A (k042644)
• Aeskulisa™ tTG-G (k042644)

Submission Summary (Full Text)

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SQI DIAGNOSTICS
TM

JUN - 2 2011

36 Meteor Toronto ON M9W 1A4 [w] 416.674.9500 [f] 416.674.9300 www.sqidiagnostics.com

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Name: | SQI Diagnostics Systems Inc. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Address: | 36 Meteor Drive<br>Toronto, Ontario<br>Canada<br>M9W 1A4 |
| Phone: | 416-674-9500 x 324 |
| FAX: | 416-674-9300 |
| Contact: | Harumi Kumahara |
| Email: | [e-mail] |
| Date Prepared: | April 7, 2011 |
| Trade Name: | IgX PLEX™ Celiac Qualitative Assay |
| Common Name: | Integrated system for the qualitative detection of IgA and IgG class of<br>anti-tissue transglutaminase in serum samples |
| Classification: | Class II |
| Product Code: | MVM-866.5660: Autoantibodies, Endomysial (Tissue<br>Transglutaminase) |
| Substantial<br>Equivalence: | Aesku, Inc.- Aeskulisa tTG A and tTG G (K042644) |

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#### Intended Use

The IgX PLEX™ Celiac Qualitative Assay is an in vitro diagnostic test for the qualitative detection of the IgA and IgG immunoglobulin classes of anti-tissue transglutaminase antibody in serum. The test is intended for use in clinical laboratories as an aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.

#### Device Description

The IgX PLEX™ Celiac Qualitative Assay is a consumable reagent kit. It is designed to run on the SQiDworks™ Diagnostics Platform. The kit includes a Microarray Plate, Reporter mix, standards, controls, sample diluents, wash buffer concentrates and a CD-ROM.

The Assay Kit detects the presences of the IgG classes of anti-tissue transglutaminase antibody. This is performed in an integrated fashion on the SQiDworks™ Diagnostics Platform (platform) that reports both analytes simultaneously to aid in the diagnosis of Celiac Disease.

The platform automates the entire immunoassay procedure from end-to-end, including calibrator/standards and sample pipetting, sample dilution, incubation, washing, and drying. Once the assay's biochemical reactions have completed, the instrument automatically performs a multi-color fluorescent scan of each well in the microarray, analyzes the data, and generates a report containing qualitative results for both assay markers. Results for each patient sample from the IgX PLEX™ Celiac Qualitative assay are obtained simultaneously for each of the two markers using the results from one well containing one aliquot of the patient's serum. Results are reported independently.

#### Comparison to Predicates

The IgX PLEX™ Celiac Qualitative Assay uses the same ELISA assay principles of capture antigen, sample addition/incubation, reporter addition/incubation and fluorescent signal interpretation as the predicates with the improvements of using an automated system and multiplexing immunoassay. The intended use of the IgX PLEX™ Celiac Qualitative Assay and its predicates are equivalent, to aid in the diagnosis of Celiac Disease.

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Image /page/2/Picture/0 description: The image shows the logo for SQI Diagnostics. The logo consists of the letters "SQI" in a bold, serif font, followed by the word "DIAGNOSTICS" stacked vertically to the right of the "I". To the right of the word "DIAGNOSTICS" is a stylized image of a teardrop or droplet, with a highlight suggesting a glossy surface. The "TM" symbol is located to the upper right of the droplet.

aidiaanostics.com

#### Test Studies

A series of test studies were conducted in support of the comparability, safety and effectiveness of the IgX PLEX™ Celiac Qualitative Study and its predicates. The studies completed with the results as follows:

- Reproducibility ranges were 92.4% to 100% for anti-tTG-IgA and 95.8%-100% . for anti-tTG-lgG.
- Clinical sensitivity was 98.3% for anti-tTG-IgA and 80.9% for anti-tTG-IgG. . Clinical specificity was 94.5% for anti-tTG-IgA and 89.0% for anti-tTG-IgG.
- Overall agreement between the analytes in the IgX PLEX™ Celiac Qualitative . Assay and established predicate test systems was 89.3% for anti-tTG-lgA and 85.1% for anti-tTG-IgG.
- . None of the analytes in the assay were affected by high levels of the following biological substances: bilirubin, hemoglobin, triglycerides and human IgG.

#### Conclusion

In conclusion, the IgX PLEX™ Celiac Qualitative Assay demonstrated performance, safety and effectiveness equivalent or superior to its predicates.

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Public Health Service

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

SQI Diagnostics Systems Inc. c/o Dr. Kate Smith Vice President, Regulatory Affairs 36 Meteor Drive Toronto, Ontario, Canada M9W 1A4

JUN 0 2 2011

Re: k102490

Trade/Device Name: IgX PLEXTM Celiac Qualitative Assay Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: May 27, 2011 Received: May 31, 2011

Dear Dr. Smith:

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. Ilsting 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 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 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

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#### Page 2 - Dr. Kate Smith

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/ReportaProblem/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 yours,

Reena Philip

City

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): K102490

Device Name: IgX PLEX™ Celiac Qualitative Assay

### Indications For Use:

The IgX PLEX™ Celiac Qualitative Assay is an in vitro diagnostic test for the qualitative detection of the IgA and IgG immunoglobulin classes of anti-tissue transglutaminase antibody in serum. The test is intended for use in clinical laboratories as an aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Reena Philip

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102490

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