(153 days)
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No
The device is a standard enzyme immunoassay kit for detecting antibodies, with no mention of AI/ML in the description, intended use, or performance studies.
No
The device is an in vitro diagnostic enzyme immunoassay used for the detection of IgA/IgG specific antibodies to aid in the diagnosis of celiac disease. It does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic enzyme immunoassay" and "is an aid in the diagnosis of celiac disease".
No
The device description clearly states it is an in vitro diagnostic enzyme immunoassay kit consisting of physical components like microtiter plates, reagents, and solutions, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Eu-tTG® IgA is an in vitro diagnostic enzyme immunoassay..."
"The Eu-tTG® IgG is an in vitro diagnostic enzyme immunoassay..."
This directly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Eu-tTG® IgA is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgA specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
The Eu-tTG® IgG is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgG specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
Product codes (comma separated list FDA assigned to the subject device)
MVM
Device Description
Each test kit for Eu-tTG® IgA & Eu-tTG® IgG consists of one (1) microtiter plate (12 strips with 8 microwells coated with the human recombinant tTG antigen), assay controls (positive and negative), a ready-to-use set of five (5) calibrators, Horseradish Peroxidase (HRP) goat anti-human IgA or IgG conjugate, serum diluent, Tetramethylbenzidine (TMB) enzyme substrate, stop solution, and washing solution required for the assay.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Eu-tTG® IgA
-
Method Comparison Study:
- Sample Size: 179 clinical samples (clinically diagnosed celiac positive/negative). Negative samples from healthy blood donors, IBD patients, food intolerance patients, and patients with autoimmune or infectious diseases.
- Key Results (with Borderline Samples Considered Positive, Cut-off 9 AU/mL):
- Positive % Agreement = 94.6% (95% CI 86.7% - 98.5%)
- Negative % Agreement = 98.1% (95% CI 93.3% - 99.8%)
- Overall % Agreement = 96.6% (95% CI 92.8% - 98.8%)
- Key Results (with Borderline Samples Considered Negative, Cut-off 16 AU/mL):
- Positive % Agreement = 82.4% (95% CI 71.8% - 90.3%)
- Negative % Agreement = 100.0% (95% CI 96.5% - 100.0%)
- Overall % Agreement = 92.7% (95% CI 87.9% - 96.1%)
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Clinical Study:
- Sample Size: 363 clinical samples (121 positive celiac patients diagnosed by clinical findings and/or biopsy; 242 negative samples from healthy subjects, autoimmune disorder patients, infectious disease patients, and IBD patients).
- Key Results (Borderline Samples Considered Positive, Cut-off 9 AU/mL):
- Sensitivity = 97.5% (95% C.I. 92.9% - 99.5%)
- Specificity = 98.3% (95% C.I. 95.8% - 99.5%)
- Positive Predicative Value (PPV) = 96.7% (95% C.I. 91.8% - 99.1%)
- Negative Predicative Value (NPV) = 98.8% (95% C.I. 96.4% - 99.7%)
- Key Results (Borderline Samples Considered Negative, Cut-off 16 AU/mL):
- Sensitivity = 85.1% (95% C.I. 77.5% - 90.9%)
- Specificity = 99.2% (95% C.I. 97.0% - 99.9%)
- PPV = 98.1% (95% C.I. 93.3% - 99.8%)
- NPV = 93.0% (95% C.I. 89.2% - 95.8%)
Eu-tTG® IgG
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Method Comparison Study:
- Sample Size: 178 clinical samples (51 clinically diagnosed Celiac positive including 8 total IgA deficient celiac patients; 127 negative samples from healthy blood donors, IBD patients, food intolerance patients, and patients with autoimmune or infectious diseases).
- Key Results (Cut-off 20 AU/mL):
- Positive % Agreement = 88.9% (95% CI 77.4% - 95.8%)
- Negative % Agreement = 94.4% (95% CI 88.7% - 97.7%)
- Overall % Agreement = 92.7% (95% CI 87.8% - 96.1%)
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Clinical Study:
- Sample Size: 407 clinical samples (165 positive celiac patients diagnosed by clinical findings and/or biopsy; 242 negative samples from healthy subjects, autoimmune disorder patients, infectious disease patients, and IBD patients).
- Key Results:
- Sensitivity = 57% (95% C.I. 49% - 64.6%)
- Specificity = 94.2% (95% C.I. 90.5% - 96.8%)
- PPV = 87.0% (95% C.I. 79.2% - 92.7%)
- NPV = 76.3% (95% C.I. 71.0% - 81.0%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Eu-tTG® IgA Clinical Performance (Borderline Samples Considered Positive, Cut-off 9 AU/mL):
Sensitivity = 97.5% (95% C.I. 92.9% - 99.5%)
Specificity = 98.3% (95% C.I. 95.8% - 99.5%)
Positive Predicative Value (PPV) = 96.7% (95% C.I. 91.8% - 99.1%)
Negative Predicative Value (NPV) = 98.8% (95% C.I. 96.4% - 99.7%)
Eu-tTG® IgA Clinical Performance (Borderline Samples Considered Negative, Cut-off 16 AU/mL):
Sensitivity = 85.1% (95% C.I. 77.5% - 90.9%)
Specificity = 99.2% (95% C.I. 97.0% - 99.9%)
PPV = 98.1% (95% C.I. 93.3% - 99.8%)
NPV = 93.0% (95% C.I. 89.2% - 95.8%)
Eu-tTG® IgG Clinical Performance:
Sensitivity = 57% (95% C.I. 49% - 64.6%)
Specificity = 94.2% (95% C.I. 90.5% - 96.8%)
PPV = 87.0% (95% C.I. 79.2% - 92.7%)
NPV = 76.3% (95% C.I. 71.0% - 81.0%)
Linearity/Assay Reportable Range:
Linear range for Eu-tTG® IgA: 4.1-99.8 AU/mL
Claimed assay range for Eu-tTG® IgA: 1.6 (LoD) to 100 AU/mL
Linear range for Eu-tTG® IgG: 4.2-99.9 AU/mL
Claimed assay range for Eu-tTG® IgG: 1.5 (LoD) to 100 AU/mL
Detection Limit:
Eu-tTG® IgA: LoB (AU/mL) = 0.05, LoD (AU/mL) = 1.6
Eu-tTG® IgG: LoB (AU/mL) = 0.02, LoD (AU/mL) = 1.5
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Eu-tTG® IgA umana (K010625), Aeskulisa tTG G (K042644)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
GRIFOLS
Grifols USA, Inc 2410 Lillyvale Avenue Los Angeles, CA 90032-3548 Tel. (323) 225-2221 (800) 421-0008 www.grifols.com
MAR - 7 2011
Page 1
510(k) Summary
Date 510(k) Summary Prepared: 4 March 2011 1.
- Grifols USA, LLC 510(k) Owner:
Grifols USA, LLC 3. Submitter:
| Submitter Name: | Grifols USA, LLC. |
|---|---|
| Contact Person: | Catherine L. Wong |
| Address: | 2410 Lillyvale Avenue |
| Los Angeles, CA 90032-3514 | |
| Telephone: | (323) 227-7280 |
| Fax No .: | (323) 441-7902 |
4.
| Proprietary and Established Names: | Eu-tTG® IgA & Eu-tTG® IgG |
|---|---|
| Common Names: | Human Tissue Transglutaminase IgA & |
| IgG |
5. Regulatory Information:
21 CFR § 866.5660 Regulation No .: Multiple autoantibodies immunological test system Regulation Section: Classification: Class II MVM, Autoantibodies, Endomysial (Tissue Transglutaminase) Product Code: Immunology (82) Panel:
Predicate Devices: 6.
Eu-tTG® IgA umana (K010625), predicate for Eu-tTG® IgA Aeskulisa tTG G (K042644), predicate for Eu-tTG® IgG
Device Information
1
7. Device Description
Each test kit for Eu-tTG® IgA & Eu-tTG® IgG consists of one (1) microtiter plate (12 strips with 8 microwells coated with the human recombinant tTG antigen), assay controls (positive and negative), a ready-to-use set of five (5) calibrators, Horseradish Peroxidase (HRP) goat anti-human IgA or IgG conjugate, serum diluent, Tetramethylbenzidine (TMB) enzyme substrate, stop solution, and washing solution required for the assay.
Intended Use 8.
The Eu-tTG® IgA is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgA specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
The Eu-tTG® IgG is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgG specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
Summary of Comparison with Predicate Device 9.
The proposed devices (Eu-tTG® IgA & Eu-tTG® IgG) have been compared with their predicate devices (Eu-tTG® IgA umana, K010625 & Aeskulisa tTG G, K042644, respectively), and found to be substantially equivalent.
The design, features, technological characteristics, specifications and performance of the proposed devices have been compared with those of the predicate devices, as shown in Tables 1, 2, 3 and 4.
2
| SIMILARITIES | ||
|---|---|---|
| Device | Predicate | |
| Item | Eu-tTG® IgA | Eu-tTG® IgA umana (K010625) |
| Intended Use | The Eu-tTG® IgA is an in vitro | |
| diagnostic enzyme immunoassay for | ||
| the semi-quantitative detection of IgA | ||
| specific antibodies directed against | ||
| tissue transglutaminase (tTG) in | ||
| human serum. It is an aid in the | ||
| diagnosis of celiac disease and should | ||
| be used in conjunction with other | ||
| serological tests and clinical findings. | Eu-tTG® IgA Umana Assay is a | |
| qualitative ELISA test for the in vitro | ||
| diagnostic detection of IgA antibody | ||
| against the recombinant enzyme | ||
| tissue transglutaminase (tTG) in | ||
| human serum. This test is designed | ||
| for use as an aid in the diagnosis of | ||
| Celiac Disease. | ||
| Methodology | ELISA | Same |
| Analyte | Anti-human tissue transglutaminase | |
| (tTG) IgA antibodies | Same | |
| Capture Antigen | Human recombinant tTG | Same |
| Detection Antibody | Goat anti-human IgA conjugate | Same |
| Enzyme Conjugate | Horseradish peroxidase (HRP) | Same |
| Substrate/Chromogen | TMB | Same |
| OD Reading | 450 nm on spectrophotometer | Same |
| Positive Control | Human serum positive for tTG IgA | |
| Antibodies | Same | |
| Negative Control | Human serum | Same |
| Controls | One positive control | |
| One negative control | Same | |
| Storage | 2-8° C | Same |
| Sample Volume | ||
| Required | 100 μL | Same |
| Sample Diluent | Ready-to-use | Same |
| Wash Solution/Buffer | 20 X concentrated | Same |
Table 1 Device Similarity Between Eu-tTG® IgA and Predicate (Eu-tTG® IgA umana, K010625)
Table 2 Device Differences Between Eu-1TG® IgA and Predicate (Eu-1TG® IgA umana K010625)
DIFFERENCES
| DIFFERENCES | ||
|---|---|---|
| Device | Predicate | |
| Item | Eu-tTG® IgA | Eu-tTG® IgA Umana Assay (K010625 |
| Assay Format | Semi-quantitative | Qualitative |
| Cutoff | 9 AU/mL | 7 AU/mL (Ages 2 to Adult); |
| 5 AU/mL (Children 16 AU/mL |
The assay cut-off value for Eu-tTG® IgG was determined as follows: Negative Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102964
15
Indication for Use Statement for Eu-tTG® IgA 4.1
510(k) Number (if known): K 102964
Device Name: Eu-tTG® IgA
Indication for Use:
The Eu-tTG® IgA is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgA specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 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 (OVD)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102964