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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and study findings for the Ig plex Celiac DGP Panel, based on the provided document:

1. Table of Acceptance Criteria & Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a go/no-go fashion with numerical targets for all performance metrics. However, it presents various performance results without indicating that they failed to meet any internal or regulatory thresholds. The following table summarizes what can be inferred as the expected performance based on the reported study results:

Performance Metric	Acceptance Criteria (Inferred/Implied from Reported Performance)	Reported Device Performance (Ig plex Celiac DGP Panel)
Clinical Sensitivity	Acceptable sensitivity for each analyte	tTG IgA: 98.4% (95% CI: 97.3-99.5%)tTG IgG: 46.9% (95% CI: 42.5-51.3%)DGP IgA: 79.7% (95% CI: 76.1-83.2%)DGP IgG: 89.1% (95% CI: 86.3-91.8%)
Clinical Specificity	Acceptable specificity for each analyte	tTG IgA: 100.0% (95% CI: 100.0-100.0%)tTG IgG: 98.8% (95% CI: 98.1-99.5%)DGP IgA: 99.2% (95% CI: 98.6-99.8%)DGP IgG: 99.6% (95% CI: 99.2-100.0%)
Analytical Interference	Clinically acceptable recoveries (bias ≤15%) for specified interferents at given concentrations	Met for Bilirubin (0.15 mg/mL), Hemoglobin (5.00 mg/mL), Triglycerides (5.00 mg/mL), and Human IgG (0.50 mg/mL) across all analytes.
Method Agreement (Positive)	High positive agreement with predicate methods	tTG IgA: 100.0% (95% CI: 97.2-100.0%)tTG IgG: 94.1% (95% CI: 84.1-98.0%)DGP IgA: 93.3% (95% CI: 87.8-96.5%)DGP IgG: 98.5% (95% CI: 94.6-99.6%)
Method Agreement (Negative)	High negative agreement with predicate methods	tTG IgA: 87.9% (95% CI: 82.5-91.8%)tTG IgG: 84.6% (95% CI: 79.3-88.7%)DGP IgA: 95.1% (95% CI: 90.9-97.4%)DGP IgG: 90.3% (95% CI: 85.3-93.7%)
Method Agreement (Overall)	High overall agreement with predicate methods	tTG IgA: 92.9% (95% CI: 89.5-95.2%)tTG IgG: 86.3% (95% CI: 81.8-89.9%)DGP IgA: 94.3% (95% CI: 91.2-96.4%)DGP IgG: 93.6% (95% CI: 90.4-95.7%)
Precision (Inter-assay, Lot-to-Lot, Instrument-to-Instrument)	Acceptable %CV values for various concentrations across different precision studies (generally <10-15% is common for immunoassays, though specific thresholds are not provided)	Inter-assay, Lot-to-Lot, and Instrument-to-Instrument %CVs are reported across all analytes and various mean concentrations, generally ranging from ~3% to 10% (see Tables 6-17 for detailed values).

The concluding statement, "the lg_plex Celiac DGP Panel demonstrated performance, safety and effectiveness equivalent or superior to its predicates," implies that the reported performance met or exceeded the expected standards set by the predicate devices.

2. Sample Size and Data Provenance

Sensitivity and Specificity (Test Set): 378 samples
- 128 celiac biopsy-confirmed samples.
- 250 samples from other autoimmune diseases (rheumatic and infectious diseases).
- No specific country of origin is mentioned, nor is it explicitly stated whether the data is retrospective or prospective. Given the nature of these studies, it's highly likely to be retrospective, utilizing banked samples.
Method Comparison: 379 samples
- 229 positive celiac patient samples.
- 132 presumptively normal samples.
- 18 other autoimmune disease samples.
Expected Values/Cut-off Determination: 292 specimens
- 126 presumed normal.
- 56 other autoimmune disease.
- 110 celiac patient specimens.
Reference Range Determination: 328 presumptively normal donors.
- 167 males (age 19-90 years).
- 161 females (age 18-66 years).
Analytical Interference: 3 samples (2 celiac diagnosed, 1 negative).
Precision and Reproducibility: Various replicates (e.g., replicates of two for 20 days for inter-assay, replicates of five per kit for lot-to-lot and multi-instrument studies). The total number of unique samples for these studies is not clearly aggregated but involves multiple runs and sites.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set.
For the "celiac biopsy confirmed samples," the ground truth is implied to be established by the biopsy itself, which would typically be interpreted by pathologists. No number or specific qualifications of these pathologists are provided.
For "other autoimmune diseases," the diagnosis is implied as existing, but the means of diagnosis or qualifications of those who made the diagnoses are not described.

4. Adjudication Method

No adjudication method (e.g., 2+1, 3+1) is described for establishing the ground truth of the test set. The ground truth seems to be based on pre-existing diagnoses (biopsy, clinical diagnosis).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This device is an in vitro diagnostic (IVD) assay designed for laboratory use, not typically requiring human reader interpretation in the same way as an imaging AI device would. It provides numerical results for analytes.

6. Standalone Performance

Yes, the studies described are standalone performance studies. The device (Ig plex Celiac DGP Panel on the sqid-X system) is evaluated on its own ability to accurately measure the target analytes and to classify samples as positive or negative for celiac disease markers based on objective cut-off values. There is no human-in-the-loop component for the performance metrics measured here (sensitivity, specificity, agreement, precision).

7. Type of Ground Truth Used

The primary ground truth used is biopsy confirmation for celiac disease (specifically, "celiac biopsy confirmed samples").
For other conditions, it relies on existing clinical diagnoses of "other autoimmune diseases."

8. Sample Size for the Training Set

The document does not explicitly state a separate "training set" for the algorithm. For IVD diagnostic tests, the "training" equivalent often involves the development and optimization of the assay itself, selection of reagents, and establishment of cut-off values using reference populations.
The "Expected Values" section mentions that 126 presumed normal, 56 other autoimmune disease, and 110 celiac patient specimens (total 292 samples) were "evaluated for accurate determination of each analyte's cut-off." This process is analogous to defining thresholds, which could be considered part of the development/training phase for the diagnostic interpretation.

9. How the Ground Truth for the Training Set was Established

As mentioned above, if the "Expected Values" samples were used for cut-off determination (a form of "training" or optimization), the ground truth for these samples would likely be established in the same way as the test set: through biopsy confirmation for celiac patients and clinical diagnosis for other conditions/normal individuals. However, the document does not elaborate further on the process for these specific sets of samples beyond their use for cut-off determination.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K140691

Device Name Ig plex Celiac DGP Panel

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Section 8.0 (revised): 510(k) Summary

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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 DriveToronto, OntarioCanadaM9W 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, gliadinMVM: Autoantibodies, Endomysial (Tissue Transglutaminase)NSU: Instrumentation for Clinical Multiplex Test Systems
Regulation Number:	21 CFR §866.5750: Radioallergosorbent (RAST) immunological test system21 CFR §866.5660: Multiple autoantibodies immunological test system Transglutaminase)21 CFR §862.2570: Instrumentation for Clinical Multiplex Test Systems
Substantial Equivalence:	Inova Diagnostics, Inc. assays:• Quanta Lite™ Gliadin IgA II (K052143)• Quanta Lite™ Gliadin IgG II (K052142)• Quanta Lite™ h-tTG IgA ELISA (K011566)• Quanta Lite™ h-tTG IgG ELISA (K011570)

SQI Diagnostics SQiDworks™ Diagnostics Platform (K102490)

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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

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.

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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(U/mL)	Assay MeasuringRange (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

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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

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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(95% CI)	% Negative Agreement(95% CI)	% Overall Agreement(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.

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Mean(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(n=30)
Mean(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-InstrumentReproducibility (n=90)
Mean(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%

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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(n=30)
Mean(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-InstrumentReproducibility (n=90)
Mean(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%

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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(n=30)
Mean(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-InstrumentReproducibility (n=90)
Mean(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%

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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(n=30)
Mean(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-InstrumentReproducibility (n=90)
Mean(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%

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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.

Regulation Number and Section

§ 866.5660 Multiple autoantibodies immunological test system.

(a)
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).(b)
Classification. Class II (performance standards).