(376 days)
No
The summary describes a standard immunoassay for antibody detection and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic immunoassay used to aid in the diagnosis of systemic sclerosis by measuring antibodies in human serum. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "as an aid in the diagnosis of systemic sclerosis."
No
The device description explicitly states it is a "semi-quantitative solid-phase fluoroenzymeimmunoassay" and includes "assay-specific reagents, EliA method-specific reagents, and general reagents," indicating it is a laboratory-based assay with physical components, not solely software.
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 RNA polymerase III (RNA Pol III) in human serum as an aid in the diagnosis of systemic sclerosis (diffuse form) 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 living body.
- Device Description: The "Device Description" further clarifies that it's a "semi-quantitative solid-phase fluoroenzymeimmunoassay, for the determination of autoantibodies against RNA polymerase III." This describes a laboratory test performed on biological samples.
- Sample Type: The test is performed on "human serum," which is a biological sample commonly used in IVD testing.
- Purpose: The purpose is to aid in the diagnosis of a specific medical condition (systemic sclerosis), which is a typical application for IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EliA RNA Pol III is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNA polymerase III (RNA Pol III) in human serum as an aid in the diagnosis of systemic sclerosis (diffuse form) in conjunction with other laboratory and clinical findings. EliA RNA Pol III uses the EliA IgG method.
Product codes
NYO
Device Description
EliA RNA Pol III is a semi-quantitative solid-phase fluoroenzymeimmunoassay, for the determination of autoantibodies against RNA polymerase III. The EliA RNA Pol III 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 RNA Pol III Wells: coated with human recombinant RNA polymerase III . proteins - 2 carriers (12 wells each), ready to use;
- . EliA ANA 3 Positive Control 250 or 2500/5000: Human monoclonal antibodies in Tris buffer containing IqG 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;
- . EliA IgG Conjugate 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 IgG (0, 4, 10, 20, 100, 600 µg/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;
- 트 EliA IgG Calibrator Well: coated with mouse monoclonal antibodies – 4 carriers (16 wells each), ready to use;
General Reagents include:
- Development Solution: 0.01% 4-Methylumbelliferyl-β-D-galactoside, 110, 6x >170. or 6x >1165 determinations:
- .. 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
2. Comparison Studies:
- a) Method Comparison with Predicate Device:
- Sample size: 193 patient serum samples (126 SSc, 82 within measuring range).
- EliA RNA Pol III: equivocal results considered negative (N=82)
- Positive Percent Agreement: 79.2% (100% x 38/48)
- Negative Percent Agreement: 100% (100% x 34/34)
- Total Agreement: 87.8% (100% x (38+34)/82)
- EliA RNA Pol III: equivocal results considered positive (N=82)
- Positive Percent Agreement: 87.5% (100% x 42/48) (95% CI: 74.8 - 95.3)
- Negative Percent Agreement: 100% (100% x 34/34) (95% CI: 89.7 - 100)
- Total Agreement: 92.7% (100% x (42+34)/82) (95% CI: 84.8 - 97.3)
- b) Instrument Comparison:
- Sample size: 64 positive, 13 equivocal, and 23 negative serum samples.
- Comparison between Phadia 250 and Phadia 2500E.
- Regression analysis: Intercept estimate -0.67 (95% CI: -1.13 to -0.44), Slope estimate 1.05 (95% CI: 1.04 to 1.07).
3. Clinical Studies:
- a) Clinical Sensitivity and Specificity:
- Sample size: 596 clinically defined serum samples (132 Systemic Sclerosis, diffuse; 464 disease controls).
- EliA RNA Pol III - equivocal results evaluated as positive:
- Sensitivity (95% CI): Not explicitly stated as a single value across all groups, derived from table as 33/132 = 25%.
- Specificity (95% CI): 99.1% (97.8% - 99.8%)
- EliA RNA Pol III - equivocal results evaluated as negative:
- Sensitivity (95% CI): 22.7% (15.9% – 3
§ 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
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September 13, 2021
Phadia AB % Sheryl Skinner Associate Director Quality and Regulatory Phadia US Inc. 4169 Commercial Avenue Portage, Michigan 49002
Re: K202541
Trade/Device Name: EliA RNA Pol III Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: NYO Dated: March 4, 2021 Received: March 5, 2021
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
542 of the Act); 21 CFR 1000-1050.
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-
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) K202541
Device Name EliA RNA Pol III
Indications for Use (Describe)
EliA RNA Pol III is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNA polymerase III (RNA Pol III) in human serum as an aid in the diagnosis of systemic sclerosis (diffuse form) in conjunction with other laboratory and clinical findings. EliA RNA Pol III uses the EliA IgG method.
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| > Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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This 510(k) Summary is prepared in accordance with the requirements of 21 CFR Part 807.92.
Premarket Notification 510(k) No: K202541
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 RNA Pol III
Regulatory Information:
| Product Code: | NYO |
|---|---|
| Classification: | Class II |
| Regulation: | 21 CFR 866.5100 – Antinuclear Antibody Immunological |
| Test System | |
| Panel: | Immunology |
Purpose of Submission:
New Device
Measurand:
lgG autoantibodies specific to RNA polymerase III (RNA Pol III) proteins
Type of Test:
Automated semi-quantitative solid phase fluoroenzymeimmunoassay
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Intended Use:
EliA RNA Pol III is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNA polymerase III (RNA Pol III) in human serum as an aid in the diagnosis of systemic sclerosis (diffuse form) in coniunction with other laboratory and clinical findings. EliA RNA Pol III 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 RNA Pol III is a semi-quantitative solid-phase fluoroenzymeimmunoassay, for the determination of autoantibodies against RNA polymerase III. The EliA RNA Pol III test System is fully integrated and automated system which comprises of assayspecific reagents, EliA method-specific reagents, and general reagents.
Assay-Specific Reagents include:
- EliA RNA Pol III Wells: coated with human recombinant RNA polymerase III . proteins - 2 carriers (12 wells each), ready to use;
- . EliA ANA 3 Positive Control 250 or 2500/5000: Human monoclonal antibodies in Tris buffer containing IqG 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;
- . EliA IgG Conjugate 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 IgG (0, 4, 10, 20, 100, 600 µg/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;
- 트 EliA IgG Calibrator Well: coated with mouse monoclonal antibodies – 4 carriers (16 wells each), ready to use;
Phadia AB, Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, Sweden
5
General Reagents include:
-
Development Solution: 0.01% 4-Methylumbelliferyl-β-D-galactoside, 110, 6x >170. or 6x >1165 determinations:
-
.. 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 | Negative 80 Units |
| Substrate | Development Solution 0.01 %
4-Methylumbelliferyl-β-D-
galactoside,
192". No recommendations are made for dilution of samples outside measuring range in the Directions For Use. -
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 Immunoqlobulins 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.
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The instrument measures specific IgG concentrations in uq/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 previously cleared with several other EliA tests, e.g. under K141375 (EliA M2 on Phadia 250). For the E-module of the Phadia 2500 and Phadia 5000 series, they were already cleared under K061165/A003 (EliA CCP).
Shelf-life:
The stability of EliA RNA Pol III 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 18 months.
On-board stability:
The on-board stability EliA RNA Pol III carriers (containing the antigen coated wells) was tested over 6 weeks using 3 positive and 2 negative samples only on the Phadia 250 instrument. As the storage conditions in the E-module 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 RNA Pol III wells was initially tested with an accelerated and then verified in a real-time study. The real-time study confirmed the shelf-life of 9 months at 2-8°C after first opening which was assigned to EliA RNA Pol III 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 IgG 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 RNA Pol III Well lots over three different days on a Phadia 250 and Phadia 2500E each in 5-fold determination. 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).
11
The results are summarized in the table below:
| Instrument | LoB
EliA U/mL | LoD
EliA U/mL | LoQ
EliA U/mL |
|-------------------------------------------------------|------------------|------------------|------------------|
| Phadia 250 | 0.0 | 0.2 | 0.4 |
| E-module of the Phadia 2500
and Phadia 5000 series | 0.0 | 0.1 | 0.3 |
The presented data have been acquired according to the CLSI Guideline EP17. The results are all below, and therefore in support of the current worldwide harmonized limits (LoD=LoQ, both set to 0.7 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 0.94 – 1.04 for EliA RNA Pol III. 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 | 500 IU/mL |
| 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 |
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Reference Sera:
Externally defined sera should be measured according to their target values as mentioned by the institution CDC. Using EliA RNA Pol III, all 12 CDC samples were detected according to their target.
Assay Cut-Off:
To define the cut-off, a study was performed using a cohort consisting of 70 apparently healthy blood donor samples and 17 target disease (Systemic Sclerosis, diffuse) samples. The samples were measured on a Phadia 250 instrument.
The cut-off was set as follows for EliA RNA Pol III:
| 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 193 patient serum samples, including 126 with the diagnosis of SSc, were used during this study. 82 patient samples were found within the measuring range, including 50 with the diagnosis of Systemic Sclerosis. The samples were analyzed with the EliA RNA Pol III and QUANTA LITE RNA POL III 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:
EliA RNA Pol III: equivocal results considered negative
| N = 82 | QUANTA LITE RNA
POL III ELISA
positive:
≥ 20 Units | QUANTA LITE
RNA POL III
ELISA negative:
10 EliA U/mL | 38 | 0 | 38 |
| EliA RNA Pol III
negative:
7 EliA U/mL | 42 | 0 | 42 |
| EliA RNA Pol III
negative:
10 EliA U/mL | 30 | 2 | 32 |
| Negative test
≤ 10 EliA U/mL | 102 | 462 | 564 |
| Total | 132 | 464 | 596 |
Sensitivity (95% CI): 22.7% (15.9% – 30.8%) Specificity (95% CI): 99.6% (98.5% - 99.9%)
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Traditional 510(k) for EliA RNA Pol III A.6 510k Summary_V6
K202541.510kSummary.FINAL.docx
The table below shows the results for each clinical subgroup:
| Diagnosis | total
n | positive
n | positive
% |
|-----------------------------------------|------------|---------------|---------------|
| Systemic Sclerosis, diffuse | 132 | 30 | 23% |
| Target disease (Total) | 132 | 30 | |
| Systemic Sclerosis, limited | 91 | 1 | 1% |
| Systemic Sclerosis, Raynaud
Syndrome | 13 | 0 | 0% |
| 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% |
| Grave's disease | 12 | 0 | 0% |
| Primary antiphospholipid syndrome | 12 | 0 | 0% |
| Primary biliary cirrhosis | 21 | 0 | 0% |
| Sjögren's syndrome | 30 | 0 | 0% |
| Systemic lupus erythematosus | 16 | 0 | 0% |
| Type 1 Diabetes | 12 | 0 | 0% |
| Ulcerative colitis | 11 | 0 | 0% |
| Varied cancer | 30 | 0 | 0% |
| Mixed connective tissue disease | 10 | 0 | 0% |
| Rheumatoid arthritis | 40 | 0 | 0% |
| Hashimoto's disease | 10 | 0 | 0% |
| Granulomatosis with Polyangiitis | 4 | 0 | 0% |
| Bacterial infections (Total) | 35 | 0 | 0% |
| Viral infections (Total) | 72 | 1 | 1% |
| Control disease | 464 | 2 | |
| Total | 596 | | |
- b) Other Clinical Supportive Data: Not applicable.
-
- 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 RNA Pol III test is below 1%. Expected values may vary depending on the population tested.
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Traditional 510(k) for EliA RNA Pol III A.6 510k Summary_V6
K202541.510kSummary.FINAL.docx
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 RNA Pol III | 568 |