IG_PLEX CELIAC DGP PANEL
Device Facts
| Record ID | K140691 |
|---|---|
| Device Name | IG_PLEX CELIAC DGP PANEL |
| Applicant | Sqi Diagnostics Systems, Inc. |
| Product Code | MVM · Immunology |
| Decision Date | Nov 6, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5660 |
| Device Class | Class 2 |
Intended Use
The Ig_plex Celiac DGP Panel is an in vitro diagnostic test for the semi-quantitative detection of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (tTG) in human 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 sqid-X system.
Device Story
The Ig_plex Celiac DGP Panel is a multiplexed immunoassay used on the sqid-X system to detect celiac disease-related autoantibodies. The device utilizes a 96-well microarray plate containing capture spots for DGP, tTG, and internal controls. The operator manually handles samples and reagents; the sqid-X system automates plate washing, fluorescent scanning, and data analysis. The FLAIR scanner captures multi-wavelength fluorescent images of the microarray. Software algorithms perform grid registration, spot finding, and data analysis to quantify antibody levels. Results are reported independently for each of the four markers (DGP IgA/IgG, tTG IgA/IgG). The system does not provide a diagnostic interpretation. By providing semi-quantitative results, the device aids clinicians in diagnosing celiac disease when combined with other clinical and laboratory findings.
Clinical Evidence
Clinical performance was evaluated using 378 samples (128 biopsy-confirmed celiac patients and 250 non-celiac autoimmune disease controls). Sensitivity: DGP IgA 79.7%, DGP IgG 89.1%, tTG IgA 98.4%, tTG IgG 46.9%. Specificity: DGP IgA 99.2%, DGP IgG 99.6%, tTG IgA 100%, tTG IgG 98.8%. Method comparison against predicate ELISA methods showed overall agreement ranging from 86.3% to 94.3% across the four analytes.
Technological Characteristics
Multiplexed microarray immunoassay. Components: microarray plate, reporter mix, standards, controls, sample diluents, wash buffer. Sensing principle: fluorescent signal interpretation of captured antibodies. Connectivity: requires sqid-X system for scanning and analysis. Software: automated data analysis and reporting. Sterilization: not specified.
Indications for Use
Indicated for the semi-quantitative detection of IgA and IgG antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (tTG) in human serum to aid in the diagnosis of celiac disease in clinical laboratory settings.
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
- Quanta Lite™ Gliadin IgA II ELISA (k052143)
- Quanta Lite™ Gliadin IgG II ELISA (k052142)
- Quanta Lite™ h-tTG IgA ELISA (k011566)
- Quanta Lite™ h-tTG IgG ELISA (k011570)
- SQI Diagnostics SQiDworks Diagnostics Platform (k102490)
Related Devices
- K102490 — IGX PLEX CELIAC QUALITATIVE ASSAY · Sqi Diagnostics Systems · Jun 2, 2011
- K063818 — QUANTA PLEX CELIAC IGA PROFILE · Inova Diagnostics, Inc. · Jun 20, 2007
- K200230 — Aptiva Celiac Disease IgG Reagent · Inova Diagnostics, Inc. · Aug 26, 2021
Submission Summary (Full Text)
{0}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2014
SOI Diagnostics Systems Inc. Ms. Kate Smith. VP. Technology 36 Meteor Dr. Toronto. ON M9W 1A4 Canada
Re: k140691
Trade/Device Name: Ig plex Celiac DGP Panel Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: II Product Codes: MVM. MST. NSU Dated: October 6, 2014 Received: October 7, 2014
Dear Ms. 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Maria M. Chan -S
Maria M. Chan, Ph. D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) k140691
Device Name Ig plex Celiac DGP Panel
#### Indications for Use (Describe)
The Ig plex Celiac DGP Panel is an in vitro diagnostic test for the semi-quantitative detection of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (TG) in human serum. The test is intended for use in clinical laboratories as an aid in the disease in conjunction with other laboratory and clinical findings, and requires the sqid-X system.
Type of Use (Select one or both, as applicable)
| <span style="font-size: 10pt;"> <b> <span style="font-family: Symbol;">☑</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
# Section 8.0 (revised): 510(k) Summary
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for SQI Diagnostics. The logo consists of a grid of nine circles on the left, with the letters "SQI" in bold black font to the right of the circles. Below the letters, the word "DIAGNOSTICS" is written in a smaller, thinner font. The circles in the grid are arranged in three rows and three columns, with the top and bottom rows having gray circles and the middle row having blue circles.
# 510(k) Summary
| Name: | SQI Diagnostics Systems Inc. |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 36 Meteor Drive<br>Toronto, Ontario<br>Canada<br>M9W 1A4 |
| Phone: | 416-674-9500 x 329 |
| FAX: | 416-674-9300 |
| Contact: | Kate Smith |
| Email: | ksmith@sqidiagnostics.com |
| Date Prepared: | November 4, 2014 |
| Trade Name: | Ig_plex® Celiac DGP Panel |
| Common Name: | Multiplexed DGP IgA, DGP IgG, tTG IgA and tTG IgG Microarray Assay |
| Classification: | Class II |
| Product Code: | MST: Antibodies, gliadin<br>MVM: Autoantibodies, Endomysial (Tissue Transglutaminase)<br>NSU: Instrumentation for Clinical Multiplex Test Systems |
| Regulation Number: | 21 CFR §866.5750: Radioallergosorbent (RAST) immunological test system<br>21 CFR §866.5660: Multiple autoantibodies immunological test system Transglutaminase)<br>21 CFR §862.2570: Instrumentation for Clinical Multiplex Test Systems |
| Substantial Equivalence: | Inova Diagnostics, Inc. assays:<br>• Quanta Lite™ Gliadin IgA II (k052143)<br>• Quanta Lite™ Gliadin IgG II (k052142)<br>• Quanta Lite™ h-tTG IgA ELISA (k011566)<br>• Quanta Lite™ h-tTG IgG ELISA (k011570) |
- SQI Diagnostics SQiDworks™ Diagnostics Platform (k102490)
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for SQI Diagnostics. The logo consists of a grid of nine circles on the left, with the letters "SQI" in bold, black font to the right of the grid. Below the letters, the word "DIAGNOSTICS" is written in a smaller, thinner font. The circles in the grid are arranged in a 3x3 pattern, with varying shades of gray and blue.
#### Intended Use
The Ig plex® Celiac DGP Panel is an in vitro diagnostic test for the semi-quantitative detection of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (tTG) in human 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 sqid-X™ system.
#### Device Description
The Ig plex Celiac DGP Panel is a consumable reagent kit. It is designed to run on the sqid-X system. The kit includes a microarray plate, reporter mix, standards, controls, sample diluents, wash buffer concentrates and a CD-ROM.
The assay detects the presences of the IgA and IgG classes of antibody, and the IgA and lgG classes of anti-tissue transglutaminase antibody. This is performed in an integrated fashion on the sqid-X system that reports all analytes simultaneously to aid in the diagnosis of celiac disease.
The system is a multiplex immunoassay analyzer that semi-automates the protocol of a specific lg plex assay from plate washing to reporting of all assay markers for each individual patient sample. The system combines manual liquid handling (samples and reagents) with automated steps for washing, scanning, data analyses and reporting. Results for each patient sample are obtained simultaneously for each of the four markers using the results from one well containing one aliquot of the patient's serum. Results are reported independently.
#### Comparison to Predicates
The Ig plex Celiac DGP Panel uses the same ELISA assay principles of capture antigen, sample addition/incubation, reporter addition/incubation and fluorescent signal interpretation as the predicates with the improvement of multiplexing. The intended use of the Ig plex Celiac DGP Panel and its predicates are all to aid in the diagnosis of celiac disease.
#### Test Studies
A series of test studies were conducted in support of the comparability, safety and effectiveness of the lg plex Celiac DGP Panel and its predicates. The studies completed with the results as shown in the following pages.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for SQI Diagnostics. The logo consists of nine circles arranged in a 3x3 grid on the left side. To the right of the circles is the text "SQI" in a bold, sans-serif font, with the word "DIAGNOSTICS" in a smaller font below it.
### Expected Values
126 presumed normal, 56 other autoimmune disease, and 110 celiac patient specimens were evaluated for accurate determination of each analyte's cut-off in the Ig plex Celiac DGP Panel (see Table 1).
Samples are negative for the analyte if the result is less than or equal to the respective cut-off and positive if the result is greater than the respective cut-off.
The system reports values within the Assay Measuring Range (linear range) of the assay as shown in Table 1.
| Analyte | Cut-Off Values<br>(U/mL) | Assay Measuring<br>Range (U/mL) |
|---------|--------------------------|---------------------------------|
| tTG IgA | 20.0 | 16.0 - 140.0 |
| tTG IgG | 36.0 | 24.0 - 100.0 |
| DGP IgA | 15.0 | 8.0 - 110.0 |
| DGP IgG | 13.0 | 9.0 - 120.0 |
## Table 1: Cut-Off Values and Assay Measuring Range
## Analytical Interference
Two (2) celiac diagnosed samples and one (1) negative sample were evaluated for levels of interferents above physiological ranges to establish analytical specificity. Table 2: lists the levels (mg/mL) of interferents reporting clinically acceptable recoveries (bias ≤15%).
### Table 2: Analytical Interference
| | Interferent (mg/mL) | | | |
|---------|---------------------|------------|---------------|-----------|
| Analyte | Bilirubin | Hemoglobin | Triglycerides | Human IgG |
| tTG IgA | 0.15 | 5.00 | 5.00 | 0.50 |
| tTG IgG | 0.15 | 5.00 | 5.00 | 0.50 |
| DGP IgA | 0.15 | 5.00 | 5.00 | 0.50 |
| DGP IgG | 0.15 | 5.00 | 5.00 | 0.50 |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image is a logo for SQI Diagnostics. The logo consists of a grid of nine circles on the left, with the letters "SQI" in bold, black font to the right of the circles. Below the letters, the word "DIAGNOSTICS" is written in a smaller, thinner font. The circles in the grid are arranged in three rows and three columns, with the top row being gray, the middle row being blue, and the bottom row being gray.
#### Sensitivity and Specificity
The sensitivity and specificity of the Ig plex Celiac DGP Panel for each of the four analytes were determined from 378 samples including: 128 celiac biopsy confirmed samples, and 250 samples from other autoimmune diseases including rheumatic and infectious diseases. The resulting clinical sensitivities and specificities are shown in Table 3.
| Analyte | % Sensitivity (95% CI) | % Specificity (95% CI) |
|---------|------------------------|------------------------|
| tTG IgA | 98.4 (97.3-99.5%) | 100.0 (100.0-100.0%) |
| tTG IgG | 46.9 (42.5-51.3%) | 98.8 (98.1-99.5%) |
| DGP IgA | 79.7 (76.1-83.2%) | 99.2 (98.6-99.8%) |
| DGP IgG | 89.1 (86.3-91.8%) | 99.6 (99.2-100.0%) |
#### Table 3: Clinical Sensitivity and Specificity
The cross-reactivity with other autoimmune diseases was determined by analyzing the 250 patient samples diagnosed with various autoimmune diseases that were tested for the sensitivity and specificity study. Specificity was calculated for each disease with the results as shown in Table 4.
| | Specificity (%) | | | |
|---------------------------------|-----------------|---------|---------|---------|
| Disease Classification | tTG IgA | tTG IgG | DGP IgA | DGP IgG |
| SLE | 100.0 | 96.7 | 100.0 | 100.0 |
| Sjogren's Syndrome | 100.0 | 100.0 | 100.0 | 100.0 |
| Wheat Allergy | 100.0 | 100.0 | 100.0 | 100.0 |
| IBD (Crohn's Disease) | 100.0 | 100.0 | 100.0 | 100.0 |
| IBD (Ulcerative Colitis) | 100.0 | 100.0 | 100.0 | 100.0 |
| Lactose Intolerant | 100.0 | 100.0 | 87.5 | 100.0 |
| Osteoarthritis | 100.0 | 100.0 | 100.0 | 100.0 |
| Celiac 1º Relative | 100.0 | 100.0 | 100.0 | 100.0 |
| IgA Deficient, non-Celiac | 100.0 | 100.0 | 66.7 | 100.0 |
| Rheumatoid Arthritis (RA) | 100.0 | 96.2 | 100.0 | 96.2 |
| Hashimoto's Thyroiditis | 100.0 | 95.0 | 100.0 | 100.0 |
| Vasculitis | 100.0 | 100.0 | 100.0 | 100.0 |
| EBV Positive | 100.0 | 100.0 | 100.0 | 100.0 |
| Syphilis Positive | 100.0 | 100.0 | 100.0 | 100.0 |
| Diabetes Mellitus Type 2 | 100.0 | 100.0 | 100.0 | 100.0 |
| Type 1 Diabetes | 100.0 | 100.0 | 100.0 | 100.0 |
| Grave's Thyroiditis | 100.0 | 100.0 | 100.0 | 100.0 |
| Suspected celiac, normal biopsy | 100.0 | 100.0 | 100.0 | 100.0 |
| Other Autoimmune Diseases | 100.0 | 100.0 | 100.0 | 100.0 |
#### Table 4: Specificity of Other Autoimmune Diseases
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image is a logo for SQI Diagnostics. The logo consists of a grid of nine circles on the left, with the letters "SQI" in black to the right of the circles. Below the letters is the word "DIAGNOSTICS" in a smaller font. The circles in the grid are arranged in three rows of three, with the top row being gray, the middle row being blue, and the bottom row being gray.
### Method Comparison
Method comparisons consisted of testing 229 positive celiac patient samples, 132 presumptively normal samples, and 18 other autoimmune disease samples with the Ig_plex Celiac DGP Panel and with a commercially available predicate method for each of the analytes. The results are presented in Table 5.
#### Table 5: Method Agreement
| Analyte | % Positive Agreement<br>(95% CI) | % Negative Agreement<br>(95% CI) | % Overall Agreement<br>(95% CI) |
|---------|----------------------------------|----------------------------------|---------------------------------|
| tTG IgA | 100.0 (97.2-100.0%) | 87.9 (82.5-91.8%) | 92.9 (89.5-95.2%) |
| tTG IgG | 94.1 (84.1-98.0%) | 84.6 (79.3-88.7%) | 86.3 (81.8-89.9%) |
| DGP IgA | 93.3 (87.8-96.5%) | 95.1 (90.9-97.4%) | 94.3 (91.2-96.4%) |
| DGP IgG | 98.5 (94.6-99.6%) | 90.3 (85.3-93.7%) | 93.6 (90.4-95.7%) |
## Precision and Reproducibility
The precision of Ig_plex Celiac DGP Panel was evaluated according to CLSI EP5-A2 -Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition.
The inter-assay precision study consisted of testing negative samples covering the entire measuring range in replicates of two, twice a day for 20 days by two operators using one lot on one system.
The lot-to-lot reproducibility study consisted of testing negative and positive samples covering the entire measuring range in replicates of five per kit, using two kits per lot, on three kit lots on one instrument.
The multi-instrument study consisted of testing negative and positive samples covering the entire measuring range in replicates of five per kit, using two kits per lot, on three different instruments at three sites.
Table 6 through Table 16 (following pages) present the precision and reproducibility results for each analyte.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for SQI Diagnostics. The logo consists of nine circles arranged in a 3x3 grid on the left side. The circles are colored in shades of gray and blue, with a gradient effect. To the right of the circles are the letters "SQI" in a bold, sans-serif font. Below the letters is the word "DIAGNOSTICS" in a smaller, sans-serif font.
| Mean<br>(U/mL) | Within Run | | Between Run | | Between Day | | Total Precision | |
|----------------|------------|------|-------------|------|-------------|------|-----------------|------|
| | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 17.29 | 0.643 | 3.7% | 0.666 | 3.9% | 0.000 | 0.0% | 0.926 | 5.4% |
| 24.46 | 0.997 | 4.1% | 0.624 | 2.6% | 0.534 | 2.2% | 1.292 | 5.3% |
| 32.35 | 1.615 | 5.0% | 0.557 | 1.7% | 0.000 | 0.0% | 1.708 | 5.3% |
| 35.19 | 1.383 | 3.9% | 0.744 | 2.1% | 1.710 | 4.9% | 2.321 | 6.6% |
| 43.29 | 1.946 | 4.5% | 1.790 | 4.1% | 0.000 | 0.0% | 2.644 | 6.1% |
| 60.05 | 3.261 | 5.4% | 1.417 | 2.4% | 1.207 | 2.0% | 3.754 | 6.3% |
| 85.55 | 4.365 | 5.1% | 0.000 | 0.0% | 3.400 | 4.0% | 5.533 | 6.5% |
| 120.73 | 7.515 | 6.2% | 1.898 | 1.6% | 2.917 | 2.4% | 8.282 | 6.9% |
| 136.63 | 6.419 | 4.7% | 3.287 | 2.4% | 1.841 | 1.3% | 7.444 | 5.4% |
#### Table 6: tTG IgA Inter-assay Precision and Reproducibility
#### Table 7: tTG IgA Lot-to-Lot Precision and Reproducibility
| Lot-to-Lot Reproducibility<br>(n=30) | | |
|--------------------------------------|-------|------|
| Mean<br>(U/mL) | SD | %CV |
| 11.91 | 0.651 | 5.5% |
| 19.54 | 1.140 | 5.8% |
| 32.6 | 2.191 | 6.7% |
| 38.05 | 2.311 | 6.1% |
| 44.31 | 3.018 | 6.8% |
| 60.49 | 3.709 | 6.1% |
| 95.28 | 4.301 | 4.5% |
| 135.2 | 9.164 | 6.8% |
#### Table 8: tTG IgA Instrument-to-Instrument Precision and Reproducibility
| Instrument-to-Instrument<br>Reproducibility (n=90) | | |
|----------------------------------------------------|-------|------|
| Mean<br>(U/mL) | SD | %CV |
| 19.22 | 1.064 | 5.5% |
| 32.12 | 2.040 | 6.4% |
| 46.76 | 3.998 | 8.6% |
| 65.78 | 4.236 | 6.4% |
{10}------------------------------------------------
| Mean | | Within Run | Between Run | | Between Day | | Total Precision | |
|--------|-------|------------|-------------|------|-------------|------|-----------------|------|
| (U/mL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 27.56 | 1.036 | 3.8% | 1.187 | 4.3% | 0.691 | 2.5% | 1.721 | 6.2% |
| 28.22 | 2.011 | 7.1% | 1.182 | 4.2% | 1.091 | 3.9% | 2.575 | 9.1% |
| 33.72 | 2.538 | 7.5% | 0.000 | 0.0% | 1.016 | 3.0% | 2.734 | 8.1% |
| 40.65 | 2.297 | 5.7% | 2.189 | 5.4% | 1.393 | 3.4% | 3.465 | 8.5% |
| 48.39 | 3.397 | 7.0% | 1.490 | 3.1% | 0.000 | 0.0% | 3.710 | 7.7% |
| 50.61 | 3.189 | 6.3% | 0.000 | 0.0% | 1.386 | 2.7% | 3.478 | 6.9% |
| 78.54 | 4.840 | 6.2% | 1.995 | 2.5% | 2.994 | 3.8% | 6.031 | 7.7% |
| 87.78 | 3.717 | 4.2% | 2.442 | 2.8% | 3.281 | 3.7% | 5.527 | 6.3% |
| 99.21 | 6.200 | 6.2% | 3.507 | 3.5% | 3.218 | 3.2% | 7.817 | 7.9% |
#### Table 9: tTG IgG Inter-assay Precision and Reproducibility
#### Table 10: tTG IgG Lot-to-Lot Precision and Reproducibility
| Lot-to-Lot Reproducibility<br>(n=30) | | | | | |
|--------------------------------------|-------|------|--|--|--|
| Mean<br>(U/mL) | SD | %CV | | | |
| 29.58 | 1.962 | 6.6% | | | |
| 34.4 | 2.803 | 8.1% | | | |
| 43.83 | 2.981 | 6.8% | | | |
| 50.13 | 4.737 | 9.5% | | | |
| 62.01 | 4.698 | 7.6% | | | |
| 65.06 | 4.871 | 7.5% | | | |
#### Table 11: tTG lgG Instrument-to-Instrument Precision and Reproducibility
| Instrument-to-Instrument<br>Reproducibility (n=90) | | |
|----------------------------------------------------|-------|-------|
| Mean<br>(U/mL) | SD | %CV |
| 29.52 | 2.927 | 9.9% |
| 47.76 | 4.681 | 9.8% |
| 51.00 | 5.157 | 10.1% |
| 63.68 | 6.325 | 9.9% |
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for SQI Diagnostics. The logo consists of a grid of nine circles on the left, with the letters "SQI" in bold black font to the right. Below the letters, the word "DIAGNOSTICS" is written in a smaller, lighter font.
| Mean | Within Run | | Between Run | | Between Day | | Total Precision | |
|--------|------------|------|-------------|------|-------------|------|-----------------|------|
| (U/mL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 9.13 | 0.426 | 4.7% | 0.305 | 3.3% | 0.000 | 0.0% | 0.524 | 5.7% |
| 15.83 | 0.637 | 4.0% | 0.268 | 1.7% | 0.311 | 2.0% | 0.758 | 4.8% |
| 20.28 | 0.704 | 3.5% | 0.983 | 4.8% | 0.000 | 0.0% | 1.209 | 6.0% |
| 28.47 | 1.680 | 5.9% | 1.228 | 4.3% | 0.660 | 2.3% | 2.183 | 7.7% |
| 36.20 | 2.017 | 5.6% | 1.143 | 3.2% | 0.586 | 1.6% | 2.391 | 6.6% |
| 47.84 | 1.834 | 3.8% | 2.588 | 5.4% | 1.155 | 2.4% | 3.375 | 7.1% |
| 54.63 | 2.966 | 5.4% | 1.816 | 3.3% | 1.561 | 2.9% | 3.812 | 7.0% |
| 78.94 | 4.749 | 6.0% | 3.474 | 4.4% | 1.430 | 1.8% | 6.055 | 7.7% |
| 104.24 | 3.800 | 3.6% | 5.391 | 5.2% | 0.000 | 0.0% | 6.596 | 6.3% |
#### Table 12: DGP IgA Inter-assay Precision and Reproducibility
#### Table 13: DGP IgA Lot-to-Lot Precision and Reproducibility
| Lot-to-Lot Reproducibility<br>(n=30) | | |
|--------------------------------------|-------|------|
| Mean<br>(U/mL) | SD | %CV |
| 9.35 | 0.878 | 9.4% |
| 11.9 | 0.858 | 7.2% |
| 15.04 | 0.908 | 6.0% |
| 16.65 | 1.141 | 6.9% |
| 18.66 | 0.878 | 4.7% |
| 20.07 | 1.002 | 5.0% |
| 59.91 | 3.435 | 5.7% |
| 65.01 | 4.623 | 7.1% |
#### Table 14: DGP IgA Instrument-to-Instrument Precision and Reproducibility
| Instrument-to-Instrument<br>Reproducibility (n=90) | | |
|----------------------------------------------------|-------|------|
| Mean<br>(U/mL) | SD | %CV |
| 8.58 | 0.823 | 9.6% |
| 16.64 | 1.300 | 7.8% |
| 18.73 | 1.410 | 7.5% |
| 21.01 | 1.661 | 7.9% |
| 61.71 | 5.552 | 9.0% |
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for SQI Diagnostics. The logo consists of a grid of nine circles on the left, with the letters "SQI" in bold black font to the right. Below the letters, the word "DIAGNOSTICS" is written in a smaller, lighter font.
| Mean | Within Run | | Between Run | | Between Day | | Total Precision | |
|--------|------------|------|-------------|------|-------------|------|-----------------|------|
| (U/mL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 15.38 | 0.712 | 4.6% | 0.465 | 3.0% | 0.695 | 4.5% | 1.098 | 7.1% |
| 22.09 | 1.006 | 4.6% | 1.006 | 4.6% | 0.753 | 3.4% | 1.610 | 7.3% |
| 31.89 | 1.261 | 4.0% | 0.609 | 1.9% | 0.909 | 2.9% | 1.669 | 5.2% |
| 41.51 | 2.018 | 4.9% | 0.605 | 1.5% | 0.687 | 1.7% | 2.216 | 5.3% |
| 50.08 | 2.606 | 5.2% | 1.416 | 2.8% | 1.166 | 2.3% | 3.187 | 6.4% |
| 71.35 | 2.737 | 3.8% | 2.641 | 3.7% | 0.000 | 0.0% | 3.804 | 5.3% |
| 85.57 | 3.215 | 3.8% | 2.342 | 2.7% | 0.000 | 0.0% | 3.977 | 4.6% |
| 119.12 | 6.063 | 5.1% | 2.265 | 1.9% | 0.000 | 0.0% | 6.472 | 5.4% |
#### Table 15: DGP IgG Inter-assay Precision and Reproducibility
#### Table 16: DGP IgG Lot-to-Lot Precision and Reproducibility
| Lot-to-Lot Reproducibility<br>(n=30) | | | | |
|--------------------------------------|-------|------|--|--|
| Mean<br>(U/mL) | SD | %CV | | |
| 11.74 | 0.601 | 5.1% | | |
| 15.42 | 0.889 | 5.8% | | |
| 17.98 | 0.841 | 4.7% | | |
| 33.08 | 2.088 | 6.3% | | |
| 46.42 | 2.127 | 4.6% | | |
| 74.15 | 4.999 | 6.7% | | |
| 85.92 | 5.118 | 6.0% | | |
| 116.14 | 5.185 | 4.5% | | |
#### Table 17: DGP IgG Instrument-to-Instrument Precision and Reproducibility
| Instrument-to-Instrument<br>Reproducibility (n=90) | | |
|----------------------------------------------------|-------|------|
| Mean<br>(U/mL) | SD | %CV |
| 11.28 | 0.981 | 8.7% |
| 16.61 | 1.547 | 9.3% |
| 32.52 | 2.610 | 8.0% |
| 88.87 | 6.141 | 6.9% |
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image is a logo for SQI Diagnostics. The logo consists of two parts: a grid of nine circles on the left and the text "SQI DIAGNOSTICS" on the right. The circles are arranged in a 3x3 grid, with the top row being light blue, the middle row being a mix of light blue and gray, and the bottom row being gray. The text "SQI DIAGNOSTICS" is in a sans-serif font, with "SQI" being larger and bolder than "DIAGNOSTICS".
### Reference Range
Specimens from 328 presumptively normal donors (including 167 males ranging in age from 19 to 90 years, and 161 females ranging in age from 18 to 66 years) were tested. The results are presented in Table 18.
#### Table 18: Reference Range
| Analyte | tTG IgA | tTG IgG | DGP IgA | DGP IgG |
|------------------------|-----------------|----------------|---------------|---------------|
| N (% Positive) | 2 (0.61%) | 2 (0.61%) | 4 (1.22%) | 10 (3.05%) |
| Range (U/mL) | <16.00 - 100.96 | <24.00 - 54.33 | <8.00 - 46.30 | <9.00 - 55.04 |
| Negative Result (U/mL) | <20.0 | <36.0 | <15.0 | <13.0 |
| Positive Result (U/mL) | ≥20.0 | ≥36.0 | ≥15.0 | ≥13.0 |
#### Conclusion
In conclusion, the lg_plex Celiac DGP Panel demonstrated performance, safety and effectiveness equivalent or superior to its predicates.
