(232 days)
None
No
The summary describes an automated immunodiagnostic system and reagents for measuring antibodies. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the analytical performance of the assay and instrument comparison.
No
This device is for in vitro diagnostic testing to aid in the diagnosis of celiac disease by measuring antibodies, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "useful as an aid in the clinical diagnosis of patients with celiac disease."
No
The device description clearly outlines physical components like "Test Wells," "EliA Sample Diluent," and various "EliA reagents," indicating it is a system involving both hardware (the Phadia instrument and reagent containers) and chemical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro semi-quantitative measurement" of antibodies in human serum and plasma to aid in the diagnosis of celiac disease. This clearly indicates the device is used to test samples taken from the human body outside of the body.
- Device Description: The description details reagents and components used for performing tests on biological samples.
- Performance Studies: The document describes analytical and method comparison studies performed on human samples.
- Predicate Devices: The predicate devices are also IVDs (indicated by their K numbers and intended use).
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EliA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and EDTAplasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease in conjunction with other laboratory and clinical findings. EliA Celikey IqG uses the EliA IgG method on the instrument Phadia 2500/5000.
EliA Gliadin®° IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA Gliadin® IgA uses the EliA IgA method on the instrument Phadia 2500/5000.
EliA Gliadin®P IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA Gliadin® IgG uses the EliA IgG method on the instrument Phadia 2500/5000.
Product codes (comma separated list FDA assigned to the subject device)
MVM, MST
Device Description
The method-specific reagents are identical with K062583 (EliA Celikey IgG) and K093459 (EliA Gliadin® IgA and EliA Gliadin® IgG), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells:
- EliA Celikey IgG Wells are coated with human recombinant tissue transglutaminase (tTG) - 2 carriers (12 wells each), ready to use;
- EliA Gliadin®° IgA Wells are coated with synthetic deamidated gliadin peptides -- 4 carriers (12 wells each), ready to use;
- -EliA Gliadin®° IgG Wells are coated with synthetic deamidated gliadin peptides - 4 carriers (12 wells each), ready to use;
EliA Sample Diluent:
- EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use;
EliA IgG reagents (required for EliA Celikey IgG and EliA Gliadin®º IgG):
- EliA IgG Coniugate 50 or 200: ß-Galactosidase labeled anti-laG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide – 6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use
- EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use;
- EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide – 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
- EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies 4 carriers (12 wells each), ready to use.
EliA IgA reagents (required for EliA Gliadin®º IgA):
- EliA IgA Conjugate 50 or 200: ß-Galactosidase labeled anti-IgA (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide -6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use
- -EliA IgA Calibrator Strips: Human IgA (0, 0.3, 1.5, 5, 15, 80 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use;
- -EliA IgA Curve Control Strips: Human IgA (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
- -EliA IgA Calibrator Well: Coated with mouse monoclonal antibodies - 4 carriers (12 wells each), ready to use.
The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages are required to carry out EliA Celikey IgG and EliA Gliadin®º IgA and EliA Gliadinºº IgG tests.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only.
Not for point-of-care use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance - Precision/Reproducibility:
The variability was assessed in a study with a total of 21 runs (3 instruments x 7 runs) performed over 7 days. Each sample was tested in four replicates/run, totaling 84 replicates per sample.
- EliA Celikey IgG on Phadia 2500/5000:
- Mean 1.6 EliA U/mL: Total Imprecision 0.4 SD, 27.9 %CV
- Mean 7.6 EliA U/mL: Total Imprecision 0.4 SD, 5.9 %CV
- Mean 9.6 EliA U/mL: Total Imprecision 0.6 SD, 6.6 %CV
- Mean 104.4 EliA U/mL: Total Imprecision 5.3 SD, 5.1 %CV
- Mean 274.6 EliA U/mL: Total Imprecision 14.5 SD, 5.3 %CV
- EliA Gliadin®º IgA on Phadia 2500/5000:
- Mean 0.8 EliA U/mL: Total Imprecision 0.1 SD, 18.2 %CV
- Mean 7.4 EliA U/mL: Total Imprecision 0.3 SD, 3.6 %CV
- Mean 8.7 EliA U/mL: Total Imprecision 0.4 SD, 4.5 %CV
- Mean 42.8 EliA U/mL: Total Imprecision 2.1 SD, 5.0 %CV
- Mean 135.3 EliA U/mL: Total Imprecision 12.5 SD, 9.3 %CV
- EliA Gliadin®º IgG on Phadia 2500/5000:
- Mean 3.6 EliA U/mL: Total Imprecision 0.5 SD, 13.0 %CV
- Mean 7.2 EliA U/mL: Total Imprecision 0.5 SD, 7.0 %CV
- Mean 9.3 EliA U/mL: Total Imprecision 0.5 SD, 5.9 %CV
- Mean 73.7 EliA U/mL: Total Imprecision 6.0 SD, 8.1 %CV
- Mean 219.6 EliA U/mL: Total Imprecision 17.0 SD, 7.7 %CV
Analytical Performance - Linearity/assay reportable range:
- EliA Celikey IgG on Phadia 2500/5000: Reportable range 0.6 to 227 EliA U/mL. Measuring range 1.7 to 227 EliA U/mL.
- EliA Gliadin®º IgA on Phadia 2500/5000: Reportable range 0.2 to 142 EliA U/mL. Measuring range 0.4 to 142 EliA U/mL.
- EliA Gliadin®º IgG on Phadia 2500/5000: Reportable range 0.6 to 302 EliA U/mL. Measuring range 1.4 to 302 EliA U/mL.
Analytical Performance - Detection limit:
- EliA Celikey IgG: LoB 0.0 EliA U/mL, LoD 0.6 EliA U/mL, LoQ 1.7 EliA U/mL.
- EliA Gliadin®º IgA: LoB 0.0 EliA U/mL, LoD 0.2 EliA U/mL, LoQ 0.4 EliA U/mL.
- EliA Gliadin®º IgG: LoB 0.3 EliA U/mL, LoD 0.6 EliA U/mL, LoQ 1.4 EliA U/mL.
Analytical Performance - Analytical specificity:
Interference and Carry-over previously reviewed in K062583 and K093459. Phadia 2500/5000 instruments use disposable tips, making carry-over from samples to conjugate impossible.
Comparison Studies - Instrument comparison:
More than 100 samples (≥20% of the samples within ±25% of the medical decision point) were run in single replicates on one Phadia 250 (predicate) and three Phadia 2500/5000 instruments. Acceptance criteria met: slope for regression lines 0.9 - 1.1 (single replicate to single replicate) and intercept close to 0.
- EliA Celikey IgG:
- PH2500/5000 A: Intercept 0.49, Slope 0.93. PPA 97.4%, NPA 82.6%, TPA 94.0% (equivocal considered positive). PPA 95.5%, NPA 100.0%, TPA 97.0% (equivocal considered negative).
- PH2500/5000 B: Intercept 0.14, Slope 0.96. PPA 97.4%, NPA 87.0%, TPA 95.0% (equivocal considered positive). PPA 97.0%, NPA 100.0%, TPA 98.0% (equivocal considered negative).
- PH2500/5000 C: Intercept -0.28, Slope 0.98. PPA 96.1%, NPA 91.3%, TPA 95.0% (equivocal considered positive). PPA 94.0%, NPA 100.0%, TPA 96.0% (equivocal considered negative).
- EliA Gliadin®° IgA:
- PH2500/5000 A: Intercept 0.60, Slope 0.95. PPA 100.0%, NPA 90.5%, TPA 98.1% (equivocal considered positive). PPA 98.7%, NPA 96.2%, TPA 98.1% (equivocal considered negative).
- PH2500/5000 B: Intercept 0.55, Slope 0.97. PPA 100.0%, NPA 85.7%, TPA 97.1% (equivocal considered positive). PPA 100.0%, NPA 96.2%, TPA 99.0% (equivocal considered negative).
- PH2500/5000 C: Intercept -0.24, Slope 1.09. PPA 100.0%, NPA 90.5%, TPA 98.1% (equivocal considered positive). PPA 98.7%, NPA 96.2%, TPA 98.1% (equivocal considered negative).
- EliA Gliadin® IgG:
- PH2500/5000 A: Intercept -0.14, Slope 1.06. PPA 100.0%, NPA 89.5%, TPA 98.1% (equivocal considered positive). PPA 98.8%, NPA 100.0%, TPA 99.0% (equivocal considered negative).
- PH2500/5000 B: Intercept 0.43, Slope 0.99. PPA 100.0%, NPA 100.0%, TPA 100.0% (equivocal considered positive). PPA 100.0%, NPA 95.8%, TPA 99.0% (equivocal considered negative).
- PH2500/5000 C: Intercept -0.06, Slope 1.08. PPA 100.0%, NPA 94.7%, TPA 99.0% (equivocal considered positive). PPA 100.0%, NPA 91.7%, TPA 98.1% (equivocal considered negative).
Clinical studies:
Clinical performance values were reviewed in K062583 and K093459. Not applicable for clinical sensitivity and specificity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for PPA (Positive Percent Agreement), NPA (Negative Percent Agreement), and TPA (Total Percent Agreement) values from instrument comparison studies.
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.
EliA Celikey IgG on Phadia 250 instrument, K062583, EliA Gliadin®P IgA on Phadia 250 instrument, K093459, EliA Gliadin®° IgG on Phadia 250 instrument, K093459
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 1, 2019
Phadia AB % Sheryl Skinner Regulatory Director, RA/QA Phadia US Inc. 4169 Commercial Avenue Portage, Michigan 49002
Re: K181871
Trade/Device Name: EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM, MST Dated: July 10, 2018 Received: July 12, 2018
Dear Sheryl Skinner:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Douglas A. Jeffery -S
Doug Jeffery, Ph.D. Branch Chief Immunology and Flow Cytometry Branch 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) K181871
Device Name
EliA Celikey IgG Immunoassay, EliA GliadinDP IgA Immunoassay, EliA GliadinDP IgG Immunoassay
Indications for Use (Describe)
EliA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and EDTA-plasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease in conjunction with other laboratory and clinical findings. EliA Celikey IgG uses the EliA IgG method on the instrument Pladia 2500/5000.
EliA GliadinDP IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgA uses the EliA IgA method on the instrument Phadia 2500/5000.
EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgG uses the EliA IgG method on the instrument Phadia 2500/5000.
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) |
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3
A.6 510(k) Summary of Safety and Effectiveness per 21CFR 807.92(c).
This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number: K181871
B. Purpose for Submission:
Adding previously cleared assays on a new instrument platform (Phadia® 2500/5000)
C. Measurands:
Anti-tissue transglutaminase (tTG) IgG antibody Anti-gliadin IgA and anti-gliadin IgG autoantibodies
D. Type of Test:
Semi-quantitative measurement immunoassays
E. Applicant:
Phadia AB Rapsgatan 7P P.O. Box 6460 SE-751 37 Uppsala, Sweden Tel: +46-18-16 50 60
510(k) Contact Person: Sheryl Skinner Associate Director, RA/QA ImmunoDiagnostics US Thermo Fisher Scientific Phadia US Inc. 4169 Commercial Avenue Portage, Mi 49002, USA Tel. 269.568.3603 sheryl.skinner@thermofisher.com
Date of Summary Preparation:
February 28, 2019
F. Proprietary and Established Names:
EliA Celikey IgG Immunoassay EliA Gliadin®º IgA Immunoassay EliA Gliadin®º IgG Immunoassay
4
G. Regulatory Information:
-
- Requlation section:
- 21 CFR §866.5660 Multiple autoantibodies immunological test system 21 CFR §866.5750 – Radioallergosorbent (RAST) Immunological Test System
-
- Classification:
Class II
-
- Product code:
MVM Autoantibodies, endomysial (tissue transqlutaminase) autoantibodies, gliadin MST
- Product code:
-
- Panel: Immunology (82)
H. Intended use(s):
- Intended use(s):
EliA Celikey IqG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and EDTAplasma. EliA Celikey IgG is based on recombinant human tissue transqlutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease in conjunction with other laboratory and clinical findings. EliA Celikey IqG uses the EliA IgG method on the instrument Phadia 2500/5000.
EliA Gliadin®° IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA Gliadin® IgA uses the EliA IgA method on the instrument Phadia 2500/5000.
EliA Gliadin®P IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA Gliadin® IgG uses the EliA IgG method on the instrument Phadia 2500/5000.
-
Indication(s) for use: Same as intended use
-
Special conditions for use statement(s):
For prescription use only
- Special instrument requirements: ধ
Performance studies were obtained from the Phadia® 2500/5000 instrument This device is not for point-of-care use.
5
. Device Description:
The method-specific reagents are identical with K062583 (EliA Celikey IgG) and K093459 (EliA Gliadin® IgA and EliA Gliadin® IgG), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells:
- EliA Celikey IgG Wells are coated with human recombinant tissue transglutaminase (tTG) - 2 carriers (12 wells each), ready to use;
- EliA Gliadin®° IgA Wells are coated with synthetic deamidated gliadin peptides -- 4 carriers (12 wells each), ready to use;
- -EliA Gliadin®° IgG Wells are coated with synthetic deamidated gliadin peptides - 4 carriers (12 wells each), ready to use;
EliA Sample Diluent:
-
EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use;
EliA IgG reagents (required for EliA Celikey IgG and EliA Gliadin®º IgG): -
EliA IgG Coniugate 50 or 200: ß-Galactosidase labeled anti-laG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide – 6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use
-
EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use;
-
EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide – 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
-
EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies 4 carriers (12 wells each), ready to use.
EliA IgA reagents (required for EliA Gliadin®º IgA):
- EliA IgA Conjugate 50 or 200: ß-Galactosidase labeled anti-IgA (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide -6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use
- -EliA IgA Calibrator Strips: Human IgA (0, 0.3, 1.5, 5, 15, 80 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use;
- -EliA IgA Curve Control Strips: Human IgA (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
- -EliA IgA Calibrator Well: Coated with mouse monoclonal antibodies - 4 carriers (12 wells each), ready to use.
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The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages are required to carry out EliA Celikey IgG and EliA Gliadin®º IgA and EliA Gliadinºº IgG tests.
J. Substantial Equivalence Information:
- Predicate device name(s) and 510(k) number(s): EliA Celikey IgG on Phadia 250 instrument, K062583 EliA Gliadin®P IgA on Phadia 250 instrument, K093459 EliA Gliadin®° IgG on Phadia 250 instrument, K093459
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2. Comparison with predicate device:
EliA Celiac Immunoassays on Phadia 250 and Phadia 2500/5000 instruments – Similarities to predicate devices
| Feature | Predicate Device
Phadia 250 | New Device
Phadia 2500/5000 |
|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
EliA Celikey IgG | EliA Celikey IgG is intended for
the in vitro semi-quantitative
measurement of IgG antibodies
directed to tissue
transglutaminase (tTG) in human
serum and plasma. EliA Celikey
IgG is based on recombinant
human tissue transglutaminase
as antigen and is useful as an
aid in the clinical diagnosis of
patients with Celiac disease. EliA
Celikey IgG uses the EliA IgG
method on the instrument
ImmunoCAP 250*.
(* Former name of Phadia 250) | EliA Celikey IgG is intended for
the in vitro semi-quantitative
measurement of IgG antibodies
directed to tissue
transglutaminase (tTG) in human
serum and EDTA-plasma. EliA
Celikey IgG is based on
recombinant human tissue
transglutaminase as antigen and
is useful as an aid in the clinical
diagnosis of patients with celiac
disease in conjunction with other
laboratory and clinical findings.
EliA Celikey IgG uses the EliA
IgG method on the instrument
Phadia 2500/5000. |
| Intended Use
EliA GliadinDP IgA | EliA GliadinDP IgA is intended for
the in vitro semi-quantitative
measurement of IgA antibodies
directed to gliadin in human
serum and plasma (heparin,
EDTA, citrate) to aid in the
diagnosis of celiac disease in
conjunction with other laboratory
and clinical findings. EliA
GliadinDP IgA uses the EliA IgA
method on the instrument
Phadia 250. | EliA GliadinDP IgA is intended for
the in vitro semi-quantitative
measurement of IgA antibodies
directed to gliadin in human
serum or plasma (Li-heparin,
EDTA) to aid in the diagnosis of
celiac disease in conjunction
with other laboratory and clinical
findings. EliA GliadinDP IgA uses
the EliA IgA method on the
instrument Phadia 2500/5000. |
| Intended Use
EliA GliadinDP IgG | EliA GliadinDP IgG is intended for
the in vitro semi-quantitative
measurement of IgG antibodies
directed to gliadin in human
serum and plasma (heparin,
EDTA, citrate) to aid in the
diagnosis of celiac disease in
conjunction with other laboratory
and clinical findings. EliA
GliadinDP IgG uses the EliA IgG
method on the instrument
Phadia 250. | EliA GliadinDP IgG is intended for
the in vitro semi-quantitative
measurement of IgG antibodies
directed to gliadin in human
serum or plasma (Li-heparin,
EDTA) to aid in the diagnosis of
celiac disease in conjunction
with other laboratory and clinical
findings. EliA GliadinDP IgG uses
the EliA IgG method on the
instrument Phadia 2500/5000. |
| Analytical
technology:
Immuno-
fluorescence
measurement | Same | Same |
| Assay process | Same | Same |
| Common, dedicated
Phadia reagents | Same | Same
Introduction of new article
numbers for Development
Solution, Stop Solution and
Washing Solution is only due to
larger filling volumes which are
required for the bigger
instruments Phadia 2500/5000 |
| Result calculation
software; Phadia
Information Data
Manager (IDM) | Same | Same |
| Sample volume | 90 µL (20 µL of non-diluted
sample) | 90 µL (20 µL of non-diluted
sample) |
| Incubation
temperature | 37°C | 37°C |
| Conjugate volume | 90 µL | 90 µL |
| Development
Solution Volume | 90 µL | 90 µL |
| Stop Solution
Volume | 200 µL | 200 µL |
| Assay set-up | Random access | Random access |
| Reagent packaging
size | Various/Common | Various/Common
Introduction of new article
number for EliA Sample Diluent
(83-1071-01) is only due to
larger filling volume. |
| Onboard storage of
reagents | Yes | Yes |
| Feature | Predicate Device
Phadia 250 | New Device
Phadia 2500/5000 |
| Sample matrix;
Serum or plasma
type as indicated in
the DFU dependent
on assay | For EliA Celikey IgG: Serum or
plasma (EDTA, citrate)
For EliA GliadinDP IgA and IgG:
Serum or plasma (heparin,
EDTA, citrate) | For EliA Celikey IgG: serum or
EDTA-plasma
For EliA GliadinDP IgA and IgG:
Serum or plasma (Li-heparin,
EDTA) |
| Daily throughput | ~250 tests | ~2500/5000 tests |
| Sample Dilution | Phadia 250 uses a steel pipette
to dilute the samples in Dilution
Plates (Art.No. 12-3907-08) | Phadia 2500/5000 uses
disposable Pipette Tips in Racks
(Art No. 12-3805-04) for
pipetting samples in Dilution
Well (Art.No. 12-4005-69) |
| Risk for carry-over | The warning “DO NOT REUSE”
in the Phadia 250 DFU for EliA
Conjugates is due to the fact that
a low risk of conjugate
contamination by carry-over from
samples was identified. In order
to reduce the risk, the single use
statement for the conjugate was
included in the Phadia 250 DFU. | When running EliA tests on the
Phadia 2500/5000 instruments,
there is no need for this warning
statement because these
instruments use disposable tips
for pipetting samples and a
separate pipette for the
conjugate, and carry-over from
samples to conjugate is
impossible. |
| Loading of EliA
Carriers | EliA carriers are loaded manually
on the Loading Tray from where
they can be processed directly or
transferred to the cooled storage
compartment. | The Phadia 2500/5000
instruments do not have such a
Loading Tray. The EliA carriers
are loaded into racks which are
directly transferred to the cooled
storage compartment |
| Barcode reader | The Phadia 250 instrument has
a built-in barcode reader at the
front of the instrument, but the
operator needs to scan the
barcodes manually by showing
the reagents to the barcode
reader. Alternatively, the
operator can also enter the
characters below the barcode
manually. | The Phadia 2500/5000
instruments dispose of a built-in
barcode reader, and the
reagents are on a moving belt
which conveys them past the
barcode reader. The lot-specific
information will be read
automatically by the instrument
during loading. |
| Process time / Time
to patient result | Phadia 250 needs 1 minute to
process one Well.
Phadia 250 provides the results
at a one minute interval. | Phadia 2500/5000 instruments
process two Wells in parallel in
48 seconds.
Phadia 2500/5000 provides the
results at a 24 seconds interval. |
8
9
EliA Celiac Immunoassays on Phadia 250 and Phadia 2500/5000 instruments – Differences to predicate device
10
K. Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A3; Evaluation of Precision Performance of Quantitative Measurement Methods: September 2014
CLSI EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach: April 2003
CLSI EP17-A, Protocols for Determination of Limits of Detection and Limits of Quantification: October 2004.
CLSI EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples
L. Test Principle:
The EliA wells are molded cups comparable to excised wells from a microtiter plate. They are made of polystyrene and are coated with the respective antigen. The wells are at the same time a holder of the coupled antigen for convenient automation and a reaction chamber with reaction/washing solution handling based on pipetting to add and aspiration to remove liquids.
The EliA wells are coated with human recombinant tissue transglutaminase, or with synthetic deamidated gliadin peptides. If present in the patient's specimen, antibodies to these proteins bind to the specific antigen. After washing away nonbound antibodies, enzyme-labeled antibodies against human IgA or IgG antibodies (EliA IgA Conjugate or EliA IgG Conjugate) are added to form an antibody-conjugate complex. After incubation, non-bound conjugate is washed away and the bound complex is incubated with a Development Solution. After stopping the reaction, the fluorescence in the reaction mixture is measured. The higher the response value, the more specific IgA or IgG is present in the specimen. To evaluate test results, the response for patient samples is compared directly to the response for calibrators.
M. Performance Characteristics (if/when applicable):
- Analytical performance:
- a. Precision/Reproducibility:
To determine the precision of the assay, the variability was assessed in a study with a total of 21 runs (3 instruments x 7 runs).
The study was performed with 1 run/dav over a period of 7 days. Each sample was tested in four replicates/run giving in total 84 replicates per sample. The data was calculated against the calibration curve from Day 1.
The results are summarized in the table below:
11
| Mean
| (EliA U/mL) | Within-Run | Between-Run | Between-Instrument | Total Imprecision | ||||
|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| 1.6 | 0.2 | 10.0 | 0.1 | 7.2 | 0.4 | 25.0 | 0.4 | 27.9 |
| 7.6 | 0.2 | 2.8 | 0.2 | 3.1 | 0.3 | 4.2 | 0.4 | 5.9 |
| 9.6 | 0.3 | 2.7 | 0.3 | 2.6 | 0.5 | 5.4 | 0.6 | 6.6 |
| 104.4 | 2.7 | 2.6 | 3.1 | 3.0 | 3.4 | 3.3 | 5.3 | 5.1 |
| 274.6 | 8.4 | 3.1 | 6.9 | 2.5 | 9.5 | 3.5 | 14.5 | 5.3 |
EliA Celikey IgG on Phadia 2500/5000
EliA Gliadin®º IgA on Phadia 2500/5000
| Mean
(EliA
U/mL) | Within-
Run | Between-
Run | | Between-
Instrument | | Total
Imprecision | | |
|------------------------|----------------|-----------------|-----|------------------------|------|----------------------|------|------|
| | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 0.8 | 0.1 | 8.9 | 0.0 | 5.7 | 0.1 | 14.9 | 0.1 | 18.2 |
| 7.4 | 0.2 | 3.0 | 0.1 | 1.5 | 0.1 | 1.3 | 0.3 | 3.6 |
| 8.7 | 0.2 | 2.8 | 0.2 | 2.6 | 0.2 | 2.3 | 0.4 | 4.5 |
| 42.8 | 1.5 | 3.6 | 0.9 | 2.1 | 1.2 | 2.8 | 2.1 | 5.0 |
| 135.3 | 5.8 | 4.3 | 3.8 | 2.8 | 10.4 | 7.7 | 12.5 | 9.3 |
EliA Gliadin®º IgG on Phadia 2500/5000
| Mean | | Within-
Run | Between-
Run | | Between-
Instrument | | Total
Imprecision | |
|----------------|-----|----------------|-----------------|-----|------------------------|-----|----------------------|------|
| (EliA
U/mL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 3.6 | 0.3 | 8.2 | 0.2 | 5.2 | 0.3 | 8.6 | 0.5 | 13.0 |
| 7.2 | 0.2 | 3.3 | 0.4 | 5.4 | 0.2 | 3.1 | 0.5 | 7.0 |
| 9.3 | 0.3 | 2.8 | 0.5 | 5.2 | 0.0 | 0.0 | 0.5 | 5.9 |
| 73.7 | 2.6 | 3.5 | 4.9 | 6.7 | 2.2 | 3.0 | 6.0 | 8.1 |
| 219.6 | 8.2 | 3.7 | 13.2 | 6.0 | 6.8 | 3.1 | 17.0 | 7.7 |
b. Linearity/assay reportable range:
Four patient serum samples (five for Celikey IgG) were diluted in sample diluent and tested with one batch of EliA Celikey IgG, EliA Gliadin®° IgA and EliA Gliadin®° IgG Immunoassays and one set of system reagents on Phadia 2500/5000. The results of the regression analysis are summarized below:
| Dilution range
| (EliA U/mL) | Slope | Intercept | R2 |
|---|---|---|---|
| 1.3 – 35.5 | 1.03 | 0.49 | 0.99 |
| 1.8 – 32.9 | 1.02 | 0.69 | 0.99 |
| 2.2 – 196.6 | 1.02 | 1.68 | 1.00 |
| 7.1 – 174.0 | 1.01 | 2.26 | 1.00 |
| 2.8 – 227.8 | 1.04 | 2.48 | 0.99 |
EliA Celikev IgG on Phadia 2500/5000
12
The reportable range (Limit of Detection, upper limit) for EliA Celikey IgG is from 0.6 to 227 EliA U/mL. The measuring range (Limit of Quantitation, upper limit) is from 1.7 to 227 EliA U/mL.
| Dilution range
| (EliA U/mL) | Slope | Intercept | R2 |
|---|---|---|---|
| 0.4 – 28.5 | 1.00 | -0.04 | 1.00 |
| 1.3 – 137.8 | 0.99 | -1.69 | 1.00 |
| 0.6 – 26.9 | 1.00 | -0.30 | 1.00 |
| 2.1 – 162.0 | 0.99 | 0.79 | 1.00 |
EliA Gliadin®º IgA on Phadia 2500/5000
The reportable range (Limit of Detection, upper limit) for EliA Gliadin® IgA is from 0.2 to 142 EliA U/mL. The measuring range (Limit of Quantitation, upper limit) is from 0.4 to 142 EliA U/mL. Please note that concentration values between LoD and LoQ may show a higher uncertainty.
EliA Gliadin®º IgG on Phadia 2500/5000
| Dilution range
| (EliA U/mL) | Slope | Intercept | R2 |
|---|---|---|---|
| 0.6 - 26.3 | 0.99 | -0.32 | 1.00 |
| 0.8 – 54.4 | 1.00 | -0.50 | 1.00 |
| 7.0 - 334.9 | 0.98 | -5.65 | 0.99 |
| 7.3 – 288.3 | 1.00 | 1.02 | 1.00 |
The reportable range (Limit of Detection, upper limit) for EliA Gliadin® IgG is from 0.6 to 302 EliA U/mL. The measuring range (Limit of Quantitation, upper limit) is from 1.4 to 302 EliA U/mL.
Statements included in the package inserts: "Please note that concentration values between LoD and LoQ may show a higher uncertainty." "Please note that due to differing binding characteristics of the antibodies in patient samples, not all sera can be diluted linearly within the measuring range."
- Traceability, Stability, Expected values (controls, calibrators, or methods): C. The EliA IgG method was previously reviewed in K061165. The EliA IgA method was previously reviewed in K062787.
- d. Detection limit:
The limit of blank (LoB), limit of detection (LoD), and limit of quantitation studies were performed on the Phadia 2500/5000 instrument. One blank sample and three low level samples were measured in thirty-three and eleven replicates, respectively, in each of two runs.
13
EliA Celikey IgG:
The LoD for EliA Celikey IgG is 0.6 EliA U/mL, determined consistent with the guidelines in CLSI document EP17-A2 and with proportions of false positives (a) less than 5% and false negatives (β) less than 5%; based on 132 determinations with 66 blank and 66 low level replicates; and LoB of 0.0 EliA U/mL. Since none of those low level samples met the target level for the CV% of 20% a requirement for the LoQ estimation - 3 additional low level samples were measured.
All low level samples were included in the LoD estimation (6 low level samples and a total of 132 determinations).
The LoQ for EliA Celikey IgG is 1.7 EliA U/mL, determined consistent with the guidelines in CLSI document EP17-A2, based on 66 determinations of 3 low level samples that are different from the ones for the determination of the LoD, and a target uncertainty goal of 20%.
The results are summarized in the table below:
| EliA Celikey IgG (EliA U/mL) | LoB | LoD | LoQ |
|---|---|---|---|
| Phadia 2500/5000 | 0.0 | 0.6 | 1.7 |
EliA Gliadin®º IqA:
The LoD for EliA Gliadin®° IgA is 0.2 EliA U/mL, determined consistent with the guidelines in CLSI document EP17-A2 and with proportions of false positives (α) less than 5% and false negatives (β) less than 5%; based on 132 determinations with 66 blank and 66 low level replicates; and LoB of 0.0 ELiA U/mL.
The LoQ for Gliadin®º IgA is 0.4 EliA U/mL, determined consistent with the guidelines in CLSI document EP17-A2, based on 66 determinations, and a target uncertainty goal of 20%.
The results are summarized in the table below:
| EliA GliadinDP IgA (EliA U/mL) | LoB | LoD | LoQ |
|---|---|---|---|
| Phadia 2500/5000 | 0.0 | 0.2 | 0.4 |
EliA Gliadin®º IgG:
The LoD for EliA Gliadinºº IgG is 0.6 EliA U/mL, determined consistent with the guidelines in CLSI document EP17-A2 and with proportions of false positives (α) less than 5% and false negatives (β) less than 5%; based on 132 determinations with 66 blank and 66 low level replicates; and LoB of 0.3 EliA U/mL.
The LoQ for EliA Gliadinºº IgG is 1.4 EliA U/mL, determined consistent with the guidelines in CLSI document EP17-A2, based on 66 determinations, and a target uncertainty goal of 20%.
The results are summarized in the table below:
14
| EliA GliadinDP IgG (EliA U/mL) | LoB | LoD | LoQ |
|---|---|---|---|
| Phadia 2500/5000 | 0.3 | 0.6 | 1.4 |
e. Analytical specificity:
Interference: Previously reviewed in K062583 and K093459. Carry-over: Phadia 2500/5000 instruments use disposable tips for pipetting samples and a separate pipette for the conjugate, therefore carry-over from samples to conjugate is impossible.
f. Assay cut-off:
The ranges (negative, equivocal, positive) recommended for the evaluation of the test results were derived from the clinical studies (s. K062583 and K093459).
EliA Celikey IqG Well
| 10 EliA U/mL | Positive |
EliA Gliadin®º IgA Well
| 10 EliA U/mL | Positive |
EliA Gliadin®º IgG Well
| 10 EliA U/mL | Positive |
2. Comparison studies:
- Method comparison with predicate device (Instrument comparison): a. See 2c Instrument Comparison below
- b. Matrix comparison:
Previously reviewed under K062583 and K093459.
Instrument comparison C.
In the Method Comparison studies for the three EliA tests included in this submission, more than 100 samples (≥20% of the samples within ±25% of the medical decision point) were run in single replicates on one Phadia 250 and three Phadia 2500/5000 instruments. The acceptance criteria for the method comparison (the slope for the regression lines should be 0.9 - 1.1 for single replicate to single replicate and intercept close to 0) were met for EliA Celikey IgG, EliA Gliadin®º IgA and EliA Gliadin®º IgG.
15
EliA Celikey lgG:
| Instrument | Intercept | 95% Cl | Slope | 95% Cl |
|---|---|---|---|---|
| PH2500/5000 A | 0.49 | 0.26 to 0.73 | 0.93 | 0.91 to 0.94 |
| PH2500/5000 B | 0.14 | -0.19 to 0.46 | 0.96 | 0.93 to 1.00 |
| PH2500/5000 C | -0.28 | -0.55 to -0.00 | 0.98 | 0.97 to 1.00 |
equivocal results considered positive
| criteria | PH2500/5000 A | PH2500/5000 B | PH2500/5000 C |
|---|---|---|---|
| PPA | 97.4% | 97.4% | 96.1% |
| 95% CI | 90.9% - 99.7% | 90.9% - 99.7% | 89.0% - 99.2% |
| NPA | 82.6% | 87.0% | 91.3% |
| 95% CI | 61.2% - 95.0% | 66.4% - 97.2% | 72.0% - 98.9% |
| TPA | 94.0% | 95.0% | 95.0% |
| 95% CI | 87.4% - 97.8% | 88.7% - 98.4% | 88.7% - 98.4% |
equivocal results considered negative
| criteria | PH2500/5000 A | PH2500/5000 B | PH2500/5000 C |
|---|---|---|---|
| PPA | 95.5% | 97.0% | 94.0% |
| 95% CI | 87.5% - 99.1% | 89.6% - 99.6% | 85.4% - 98.3% |
| NPA | 100.0% | 100.0% | 100.0% |
| 95% CI | 89.4% - 100.0% | 89.4% - 100.0% | 89.4% - 100.0% |
| TPA | 97.0% | 98.0% | 96.0% |
| 95% CI | 91.5% - 99.4% | 93.0% - 99.8% | 90.1% - 98.9% |
16
EliA Gliadin®° IgA:
| Instrument | Intercept | 95% Cl | Slope | 95% Cl |
|---|---|---|---|---|
| PH2500/5000 A | 0.60 | 0.40 to 0.93 | 0.95 | 0.92 to 0.98 |
| PH2500/5000 B | 0.55 | 0.28 to 0.83 | 0.97 | 0.95 to 1.00 |
| PH2500/5000 C | -0.24 | -0.71 to -0.06 | 1.09 | 1.06 to 1.11 |
equivocal results considered positive
| criteria | PH2500/5000 A | PH2500/5000 B | PH2500/5000 C |
|---|---|---|---|
| PPA | 100.0% | 100.0% | 100.0% |
| 95% CI | 95.7% - 100.0% | 95.7% - 100.0% | 95.7% - 100.0% |
| NPA | 90.5% | 85.7% | 90.5% |
| 95% CI | 69.6% - 98.8% | 63.7% - 97.0% | 69.6% - 98.8% |
| TPA | 98.1% | 97.1% | 98.1% |
| 95% CI | 93.3% - 99.8% | 91.9% - 99.4% | 93.3% - 99.8% |
equivocal results considered negative
| criteria | PH2500/5000 A | PH2500/5000 B | PH2500/5000 C |
|---|---|---|---|
| PPA | 98.7% | 100.0% | 98.7% |
| 95% CI | 93.2% - 100.0% | 95.4% - 100.0% | 93.2% - 100.0% |
| NPA | 96.2% | 96.2% | 96.2% |
| 95% CI | 80.4% - 99.9% | 80.4% - 99.9% | 80.4% - 99.9% |
| TPA | 98.1% | 99.0% | 98.1% |
| 95% CI | 93.3% - 99.8% | 94.8% - 100.0% | 93.3% - 99.8% |
EliA Gliadin® IgG:
| Instrument | Intercept | 95% Cl | Slope | 95% Cl |
|---|---|---|---|---|
| PH2500/5000 A | -0.14 | -0.41 to 0.13 | 1.06 | 1.04 to 1.09 |
| PH2500/5000 B | 0.43 | 0.13 to 1.16 | 0.99 | 0.94 to 1.02 |
| PH2500/5000 C | -0.06 | -0.20 to 0.20 | 1.08 | 1.07 to 1.10 |
17
| criteria | PH2500/5000 A | PH2500/5000 B | PH2500/5000 C |
|---|---|---|---|
| PPA | 100.0% | 100.0% | 100.0% |
| 95% CI | 95.8% - 100.0% | 95.8% - 100.0% | 95.8% - 100.0% |
| NPA | 89.5% | 100.0% | 94.7% |
| 95% CI | 66.9% - 98.7% | 82.4% - 100.0% | 74.0% - 99.9% |
| TPA | 98.1% | 100.0% | 99.0% |
| 95% CI | 93.2% - 99.8% | 96.5% - 100.0% | 94.8% - 100.0% |
equivocal results considered positive
equivocal results considered negative
| criteria | PH2500/5000 A | PH2500/5000 B | PH2500/5000 C |
|---|---|---|---|
| PPA | 98.8% | 100.0% | 100.0% |
| 95% CI | 93.2% - 100.0% | 95.5% - 100.0% | 95.5% - 100.0% |
| NPA | 100.0% | 95.8% | 91.7% |
| 95% CI | 85.8% - 100.0% | 78.9% - 99.9% | 73.0% - 99.0% |
| TPA | 99.0% | 99.0% | 98.1% |
| 95% CI | 94.8% - 100.0% | 94.8% - 100.0% | 93.2% - 99.8% |
-
- Clinical studies:
- a. Clinical sensitivity: Not applicable.
- Clinical specificity: b. Not applicable.
- c. Other clinical supportive data (when a. and b. are not applicable): Clinical performance values were reviewed in K062583 and K093459.
-
- Clinical cut-off: Same as assay cut-off.
- Expected values/Reference range: 5.
The frequency distribution for anti-tTG IgG and anti-gliadin IgA and IqG antibodies was investigated in a group of apparently healthy subjects equally distributed by age and gender, using sera from a Caucasian population obtained from a blood bank.
The results are given in the table below:
18
| Test | n = | Median
(EliA U/mL) | 95th
percentile | 99th
percentile |
|-------------------------------------------|-----|-----------------------|--------------------|--------------------|
| EliA Celikey IgG on
Phadia 2500/5000 | 400 | 2.3 | 3.3 | 3.9 |
| EliA GliadinDP IgA on
Phadia 2500/5000 | 400 | 1.4 | 3.8 | 7.1 |
| EliA GliadinDP IgG on
Phadia 2500/5000 | 400 | 0.9 | 2.7 | 13.3 |
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
All available data support that both instrument platforms, Phadia 250 and Phadia 2500/5000 perform substantially equivalent when using the EliA Celikey IgG, EliA Gliadin®º IgA and EliA Gliadinºº IgG immunoassays.
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.