(376 days)
No
The device description and performance studies focus on a standard immunoassay method and its analytical and clinical performance, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as an in vitro diagnostic (IVD) device intended for the semi-quantitative measurement of antibodies as an aid in diagnosing systemic lupus erythematosus (SLE). It is used for diagnosis, not for treating or preventing a disease, which is characteristic of therapeutic devices.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Rib-P in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE)." This explicitly identifies its purpose as an aid in diagnosis, making it a diagnostic device.
No
The device description explicitly lists numerous physical components including wells, controls, calibrators, and various reagents, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Rib-P in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings." The phrase "in vitro" is a key indicator of an IVD, meaning it's used to test samples outside of the body.
- Device Description: The description details the components of the "EliA Rib-P test System," which includes reagents and wells designed for laboratory testing of human serum.
- Prescription Use: The "Intended User / Care Setting" indicates "Prescription Use (Part 21 CFR 801 Subpart D)," which is a common classification for IVDs used in a clinical setting.
- Performance Studies: The document describes various analytical and clinical performance studies conducted on the device using patient samples, which is standard for the validation of IVDs.
- Predicate Device: The mention of a "Predicate Device" (Quanta Lite Ribosome P ELISA) is also typical for regulatory submissions of IVDs, where a new device is compared to an already cleared device.
All of these elements strongly indicate that the EliA Rib-P is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EliA Rib-P is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Rib-P in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Rib-P uses the EliA IgG method.
Product codes (comma separated list FDA assigned to the subject device)
MOA, MQA
Device Description
EliA Rib-P is a semi-quantitative solid-phase fluoroenzymeimmunoassay, for the determination of autoantibodies against Rib-P. The EliA Rib-P test System is fully integrated and automated system which comprises of assay-specific reagents, EliA method-specific reagents, and general reagents.
Assay-Specific Reagents include:
- EliA Rib-P Wells: coated with human recombinant ribosomal P-proteins P0, P1 . and P2 - 2 carriers (12 wells each), ready to use;
- . EliA ANA 3 Positive Control 250 or 2500/5000: Human monoclonal antibodies in Tris buffer containing IgG antibodies to Ro52, Rib-P and RNA Pol III – 6 single use vials, 0.3 mL each, ready to use;
- . EliA IgG/IgM/IgA Negative Control 250 or 2500/5000: Human blood preparation from healthy donors in PBS containing BSA, detergent and 0.095% sodium azide - 6 single-use vials, 0.3 mL each, ready to use;
EliA Method-Specific Reagents include: - EliA Sample Diluent: PBS containing BSA, detergent and 0.095% sodium azide . - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use;
- I EliA IqG Conjuqate 50 or 200: ß-Galactosidase labeled anti-lgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% 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 IqG (0, 4, 10, 20, 100, 600 uq/L) in PBS containing BSA, . detergent and 0.095% sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
- EliA IgG Curve Control Strips: Human IgG (20 ug/L) in PBS containing BSA, . detergent and 0.095% 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;
General Reagents include: - Development Solution: 0.01% 4-Methylumbelliferyl-β-D-galactoside, 110, 6x >170, or 6x >1165 determinations;
- I Stop Solution: 4% Sodium Carbonate - 6 bottles (65 mL, 119 mL, or 2800 mL each), sufficient for 6x >292, 6x >560, or 6x >13100 determinations;
- Washing Solution Additive: detergent, preservative 10 EliA U/mL: Positive
Comparison Studies:
- Method Comparison with Predicate Device:
- Study with 323 patient samples compared EliA Rib-P to Quanta Lite Ribosome P ELISA.
- When EliA Rib-P equivocal results were considered negative: Positive Percent Agreement 94.7% (95% CI: 82.3 - 99.4), Negative Percent Agreement 98.6% (95% CI: 96.4 - 99.6), Total Agreement 98.1% (95% CI: 96.0 - 99.3).
- When EliA Rib-P equivocal results were considered positive: Positive Percent Agreement 100% (95% CI: 90.7 - 100), Negative Percent Agreement 88.1% (95% CI: 83.7 - 91.6), Total Agreement 89.5% (95% CI: 85.6 - 92.6).
- Instrument Comparison: Performance evaluated on Phadia 250 and Phadia 2500E using 85 samples (47 positive, 10 equivocal, 28 negative). Regression analysis showed intercept of -0.76 (95% CI: -1.20 - -0.48) and slope of 0.94 (95% CI: 0.93 - 0.98).
Clinical Studies:
- Clinical Sensitivity and Specificity:
- Study with 560 clinically defined serum samples from 146 SLE patients and 414 disease controls.
- EliA Rib-P - equivocal results evaluated as positive: Sensitivity 34.9% (95% CI: 27.2% - 43.3%), Specificity 99.3% (95% CI: 97.9% - 99.9%).
- EliA Rib-P - equivocal results evaluated as negative: Sensitivity 28.1% (95% CI: 21.0 % - 36.1%), Specificity 99.8% (95% CI: 98.7% - 100%).
- For Systemic lupus erythematosus, 38/136 (28%) were positive. For Systemic lupus erythematosus with secondary antiphospholipid syndrome, 3/10 (30%) were positive. One case (2%) in Systemic sclerosis, diffuse was positive. All other disease controls had 0% positivity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
EliA Rib-P - equivocal results evaluated as positive:
Sensitivity (95% CI): 34.9% (27.2% - 43.3%)
Specificity (95% CI): 99.3% (97.9% - 99.9%)
EliA Rib-P - equivocal results evaluated as negative:
Sensitivity (95% CI): 28.1% (21.0 % - 36.1%)
Specificity (95% CI): 99.8% (98.7% - 100%)
Method Comparison with Predicate Device (EliA Rib-P: equivocal results considered negative):
Positive Percent Agreement: 94.7%
Negative Percent Agreement: 98.6%
Total Agreement: 98.1%
Method Comparison with Predicate Device (EliA Rib-P: equivocal results considered positive):
Positive Percent Agreement: 100%
Negative Percent Agreement: 88.1%
Total Agreement: 89.5%
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.
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.
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
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 13, 2021
Phadia AB % Sheryl Skinner Associate Director RA/QA Phadia US Inc. 4169 Commercial Avenue Portage, Michigan 49002
Re: K202540
Trade/Device Name: EliA Rib-P Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: MOA Dated: September 1, 2020 Received: September 2, 2020
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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying Mao, Ph.D. Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202540
Device Name EliA Rib-P
Indications for Use (Describe)
EliA Rib-P is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Rib-P in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Rib-P uses the EliA IgG method.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo of Thermo Fisher Scientific. The logo is composed of the words "Thermo Fisher" in a bold, red font on the top line, and the word "SCIENTIFIC" in a smaller, black font on the second line. The logo is simple and modern, and it is likely used to represent the company's brand.
510(k) Summary
This 510(k) Summary is prepared in accordance with the requirements of 21 CFR Part 807.92.
Premarket Notification 510(k) No: K202540
Date of Summary Preparation: September 3, 2021
| Manufacturer: | Phadia AB
Rapsgatan 7P
P.O. Box 6460
751 37 Uppsala, Sweden |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Distributor: | Phadia US Inc.
4169 Commercial Avenue
Portage, MI 49002 |
| Company Contact Person: | Sheryl Skinner
Associate Director, Regulatory and Quality
Phadia US Inc.
4169 Commercial Avenue
(269) 568-3603
sheryl.skinner@thermofisher.com |
Proprietary and Established Device Name: EliA Rib-P
Regulatory Information:
| Product Code: | MQA |
|---|---|
| Classification: | Class II |
| Regulation: | 21 CFR 866.5100 – Antinuclear Antibody Immunological |
| Test System | |
| Panel: | Immunology |
Purpose of Submission:
New Device
Measurand:
IgG autoantibodies specific to Rib-P proteins
Type of Test:
Automated semi-quantitative solid phase fluoroenzymeimmunoassay
4
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Intended Use:
EliA Rib-P is intended for the in vitro semi-quantitative measurement of lgG antibodies directed to Rib-P in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Rib-P uses the EliA IgG method.
Indication(s) for Use:
Same as intended use
Special Conditions for Use:
Rx - For Prescription Use Only
Special Instrument Requirements:
For use on the Phadia 250 instrument and the Phadia 2500 and Phadia 5000 instrument series (E-modules).
Device Description:
EliA Rib-P is a semi-quantitative solid-phase fluoroenzymeimmunoassay, for the determination of autoantibodies against Rib-P. The EliA Rib-P test System is fully integrated and automated system which comprises of assay-specific reagents, EliA method-specific reagents, and general reagents.
Assav-Specific Reagents include:
- EliA Rib-P Wells: coated with human recombinant ribosomal P-proteins P0, P1 . and P2 - 2 carriers (12 wells each), ready to use;
- . EliA ANA 3 Positive Control 250 or 2500/5000: Human monoclonal antibodies in Tris buffer containing IgG antibodies to Ro52, Rib-P and RNA Pol III – 6 single use vials, 0.3 mL each, ready to use;
- . EliA IgG/IgM/IgA Negative Control 250 or 2500/5000: Human blood preparation from healthy donors in PBS containing BSA, detergent and 0.095% sodium azide - 6 single-use vials, 0.3 mL each, ready to use;
EliA Method-Specific Reagents include:
- EliA Sample Diluent: PBS containing BSA, detergent and 0.095% sodium azide . - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use;
- I EliA IqG Conjuqate 50 or 200: ß-Galactosidase labeled anti-lgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% 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 IqG (0, 4, 10, 20, 100, 600 uq/L) in PBS containing BSA, detergent and 0.095% sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
- EliA IgG Curve Control Strips: Human IgG (20 ug/L) in PBS containing BSA, . detergent and 0.095% sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use:
5
-
EliA IgG Calibrator Well: coated with mouse monoclonal antibodies 4 carriers . (12 wells each), ready to use;
General Reagents include: -
Development Solution: 0.01% 4-Methylumbelliferyl-β-D-galactoside, 110, 6x >170, or 6x >1165 determinations;
-
I Stop Solution: 4% Sodium Carbonate - 6 bottles (65 mL, 119 mL, or 2800 mL each), sufficient for 6x >292, 6x >560, or 6x >13100 determinations;
-
트 Washing Solution Additive: detergent, preservative 10 EliA U/mL | Negative 80 Units |
| Substrate | Development Solution 0.01 %
4-Methylumbelliferyl-β-D-
galactoside. | TMB Chromogen |
7
| 403". No recommendations are made for dilution of samples outside measuring range in the Directions For Use.
10
c) Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): Traceability:
The IgG calibrators are traceable (via unbroken chain of calibrations) to the International Reference Preparation (IRP) 67/86 of Human Serum Immunoglobulins A, G and M from WHO. New batches of IgG calibrators are compared to a secondary standard (standardized with the IRP) or the IRP directly and adjusted accordingly to meet the correct concentration.
The instrument measures specific IgG concentrations in ug/L. By using a conversion factor given by the lot-specific code of the EliA test well, the results are automatically converted to EliA U/mL.
Stability:
Data for open and closed real-time stability and on-board stability of EliA IgG reagents and general EliA reagents on Phadia 250 as well as on the Emodule of the Phadia 2500 and Phadia 5000 series were already cleared with several other EliA tests, e.q. under K141375 (EliA M2 on Phadia 250). For the Phadia 2500 and Phadia 5000 instrument series, they were already cleared under K061165/A003 (EliA CCP).
Shelf-life:
The stability of EliA Rib-P Wells was evaluated with a real-time study. The results support stability of the test under the recommended storage of 2 – 8°C for up to 36 months.
On-board stability:
The on-board stability EliA Rib-P carriers (containing the antigen coated wells) was tested over 8 weeks using 3 positive and 2 negative samples only on the Phadia 250 instrument. As the storage conditions in the Emodule of the Phadia 2500 and Phadia 5000 series are similar to the Phadia 250, the results can also be used for stability claims for these instruments. The on-board stability for the Phadia 250 was determined to be 28 days at 2-8°C.
Open Stability:
Stability after first opening of the foil bag containing the EliA Rib-P wells was tested with a real-time study. According to this study, a shelf-life of 9 months at 2-8°C after first opening can be assigned to EliA Rib-P wells.
d) Detection Limit:
Four blank and four low level samples were measured with two different reagent sets (two lots of antigen wells). The four blank samples were created from depleted IqG sera, each diluted with EliA Sample Diluent. The blank samples and the low-level samples were assayed in three runs using two different sets of EliA Rib-P Well lots over three different days on a Phadia 250 and Phadia 2500E each in 5-fold determination.
Confidential Page 8 (14)
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For each instrument type, the total number of combined observations for blank and low-level samples is 120 (60 per reagent set, 15 per sample and reagent set).
The results are summarized in the table below:
| Instrument | LoB | LoD | LoQ |
|---|---|---|---|
| EliA U/mL | EliA U/mL | EliA U/mL | |
| Phadia 250 | 0.0 | 0.5 | 1.9 |
| E-module of the Phadia 2500 | |||
| and Phadia 5000 series | 0.1 | 0.4 | 1.1 |
A harmonized LoB of 0.1 EliA U/mL, LoD of 0.5 EliA U/mL, and LoQ of 1.9 EliA U/mL for the immunoassay was used.
The LoD for EliA Rib-P is 0.5 EliA U/mL, determined consistent with the quidelines in CLSI document EP17-A2 and with proportions of false positives (α) less than 5% and false negatives (β) less than 5%: based on 240 determinations with 120 blank and 120 low-level replicates per instrument type; and LoB of 0.1 EliA U/mL.
e) Analytical specificity:
Endogenous and Exogenous Interference:
A study was run to investigate whether high concentrations of potentially interfering substances in serum, like bilirubin, hemoglobin, lipemic factor, rheumatoid factor, Ibuprofen, Losartan, Hydroxychloroquine, Azathioprine, Prednisone, Rituximab and Infliximab adversely affect the results of the new device.
Three serum samples (one negative sample, one sample with a concentration within the equivocal range, and one high positive sample) were prediluted in EliA Sample Diluent and spiked with the different interfering substances or blank solution. The samples were tested in triplicates. A calibration curve was run in duplicate. The runs were repeated twice. One batch of EliA antigen wells and one batch of system reagents were used throughout the studies.
The ratio of blank/spiked sample ranged from 0.90 – 1.10 for EliA Rib-P. No interference was observed up to the concentrations listed in the table below:
| Potential Interfering
Compound | Concentration in
undiluted sample |
|-----------------------------------|--------------------------------------|
| Bilirubin F | 40 mg/dL |
| Bilirubin C | 40 mg/dL |
| Hemoglobin | 1000 mg/dL |
| Lipemic factor | 2000 mg/dL |
| Rheumatoid factor | 550 IU/mL |
Phadia AB, Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, Sweden
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| Ibuprofen | 21.9 mg/dL |
|---|---|
| Losartan | 1.14 mg/dL |
| Hydroxychloroquine | 0.23 mg/dL |
| Azathioprine | 0.26 mg/dL |
| Prednisone | 0.01 mg/dL |
| Rituximab | 109 mg/dL |
| Infliximab | 26.4 mg/dL |
Reference Sera:
Externally defined sera should be measured according to their target values as mentioned by the institution CDC. Using EliA Rib-P, all 12 CDC samples were found according to their target.
f) Assay Cut-Off:
To define the cut-off, a study was performed using a cohort consisting of 70 apparently healthy blood donors and 30 samples from SLE patients. The samples were measured on a Phadia 250 instrument.
The cut-off was set as follows for EliA Rib-P:
| 10 EliA U/mL | Positive |
In case of equivocal results, it is recommended to retest the patient after 8-12 weeks.
-
- Comparison Studies:
- a) Method Comparison with Predicate Device:
A total of 323 patient samples with concentrations covering the measuring range were tested.
The samples were analyzed with the EliA Rib-P and Quanta Lite Ribosome P ELISA assay. The test was run in single determination and evaluated according to the Directions for Use. The results are summarized in the tables below:
13
| N = 323 | Quanta Lite
Ribosome P
positive:
20 Units | Quanta Lite
Ribosome P
negative:
10 EliA U/mL | 36 | 4 | 40 |
| EliA Rib-P negative:
20 Units | Quanta Lite
Ribosome P
negative:
7 EliA U/mL | 38 | 34 | 72 |
| EliA Rib-P negative:
10 EliA U/mL | 41 | 1 | 42 |
| Negative test
≤ 10 EliA U/mL | 105 | 413 | 518 |
| Total | 146 | 414 | 560 |
Sensitivity (95% CI): 28.1% (21.0 % - 36.1%)
Phadia AB, Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, Sweden
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Specificity (95% CI): 99.8% (98.7% - 100%)
The table below shows the results for each clinical subgroup:
| total | positive | positive | |
|---|---|---|---|
| Diagnostic Groups | n | n | % |
| Systemic lupus erythematosus | 136 | 38 | 28% |
| Systemic lupus erythematosus with | |||
| secondary antiphospholipid syndrome | 10 | 3 | 30% |
| Target disease (Total) | 146 | 41 | |
| Celiac disease | 13 | 0 | 0% |
| Crohn's disease | 12 | 0 | 0% |
| CTD overlap Non-MCTD | 10 | 0 | 0% |
| Dermatomyositis | 4 | 0 | 0% |
| Polymyositis | 6 | 0 | 0% |
| Graves' disease | 12 | 0 | 0% |
| Primary antiphospholipid syndrome | 12 | 0 | 0% |
| Primary Biliary Cholangitis | 21 | 0 | 0% |
| Sjögren's syndrome | 23 | 0 | 0% |
| Type 1 Diabetes | 12 | 0 | 0% |
| Ulcerative colitis | 11 | 0 | 0% |
| Varied Cancer | 10 | 0 | 0% |
| Mixed connective tissue disease | 10 | 0 | 0% |
| Rheumatoid arthritis | 30 | 0 | 0% |
| Bacterial infections | 36 | 0 | 0% |
| Viral infections | 56 | 0 | 0% |
| Hashimoto's disease | 10 | 0 | 0% |
| Granulomatosis with Polyangiitis | 4 | 0 | 0% |
| Systemic sclerosis, diffuse | 48 | 1 | 2% |
| Autoimmune Hepatitis | 16 | 0 | 0% |
| Polymyalgia Rheumatica | 25 | 0 | 0% |
| Systemic sclerosis, limited | 33 | 0 | 0% |
| Disease Controls (Total) | 414 | 1 | |
| Total | 560 |
- b) Other Clinical Supportive Data: Not applicable.
16
-
- Clinical Cut-Off: Same as assay cut-off.
-
- Expected Values/Reference Range:
Antibody prevalence in autoimmune patients varies widely depending on disease area. The proportion of sera from a normal population found positive for the antinuclear antibodies covered by the EliA Rib-P test is below 1%. Expected values may vary depending on the population tested.
The frequency distribution for antinuclear antibodies was investigated in a group of apparently healthy subjects equally distributed by age and gender, using sera from Caucasian, African American, Hispanic and Asian population obtained from a blood bank.
The results are given in the table below:
| Test | n | Median
EliA U/mL | 95th percentile
EliA U/mL | 99th percentile
EliA U/mL |
|------------|-----|---------------------|------------------------------|------------------------------|
| EliA Rib-P | 638 | 1.6 | 3.4 | 5.0 |
Proposed Labeling
The labeling is drafted in accordance with the requirements of 21 CFR Part 809.10.
Conclusion
All available data support that both immunoassays, the new device EliA Rib-P and its predicate device Quanta Lite Ribosome P ELISA perform substantially equivalent.