(263 days)
Not Found
No.
The device description outlines a standard immunoassay technology for quantitative determination. There is no mention of AI, machine learning, or deep learning in the document, nor are there descriptions of components or processes that would inherently involve an AI model to perform its stated function (measuring relative light units for antibody detection).
No.
This device is an in vitro diagnostic (IVD) device used for the quantitative determination of IgG antibodies to rubella virus. It is used as an aid in determining immune status to rubella, not for treating or preventing rubella itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Alinity i Rubella IgG assay is "to be used as an aid in the determination of immune status to rubella in individuals including women of child-bearing age," which is a diagnostic purpose.
No
The device is a laboratory assay (chemiluminescent microparticle immunoassay) that determines the presence of IgG antibodies to rubella virus in human samples. This involves physical reagents, chemical reactions, and optical measurement on a dedicated instrument (Alinity i system). It is not a software-only device; it's an in-vitro diagnostic (IVD) assay with associated hardware.
Yes
The device is described as an "immunoassay" for "quantitative determination of IgG antibodies to rubella virus in human serum, serum separator, and plasma tubes." This directly falls under the definition of an In Vitro Diagnostic (IVD) device, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Alinity i Rubella IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of IgG antibodies to rubella virus in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the Alinity i system.
The Alinity i Rubella IgG assay is to be used as an aid in the determination of immune status to rubella in individuals including women of child-bearing age.
The Alinity i Rubella IgG assay has not been cleared for use in screening blood, plasma, or tissue donors.
The performance of this device has not been established for cord blood or neonatal samples. Likewise, performance has not been established for populations of immunocompromised or immunosuppressed individuals.
Product codes (comma separated list FDA assigned to the subject device)
LFX
Device Description
The Alinity i Rubella IgG assay is an automated, two-step immunoassay for the quantitative determination of anti-rubella IgG in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.
The kit configuration of the Alinity i Rubella IgG Reagent Kit is described below:
- List Number (LN): 04W0222
- Tests per cartridge: 100
- Number of cartridges per kit: 2
- Tests per kit: 200
- Microparticles: 6.6 mL (Partially purified rubella virus coated microparticles in TRIS buffer with surfactant. Minimum concentration: 0.12% solids. Preservatives: ProClin 950 and sodium azide.)
- Conjugate: 6.1 mL (Anti-human IgG (mouse, monoclonal) acridinium-labeled conjugate in MES buffer with protein (bovine) stabilizer and surfactant. Minimum concentration: 16 ng/mL. Preservatives: antimicrobial agents.)
- Assay Diluent: 10.4 mL (TRIS buffer with protein (caprine, bovine, murine) stabilizers and surfactant. Preservatives: ProClin 300 and ProClin 950.)
The Alinity i Rubella IgG Calibrators are described below:
- Calibrator A: Contains recalcified human plasma with protein (ovine) stabilizer. Target concentration: 0.0 IU/mL.
- Calibrator B – F: Contain recalcified human plasma (reactive for IgG antibodies to rubella virus [anti-rubella IgG]) with protein (ovine) stabilizer. Target concentrations: 5.5 IU/mL (B), 16.5 IU/mL (C), 82.5 IU/mL (D), 275.0 IU/mL (E), 550.0 IU/mL (F).
- Preservatives: ProClin 950 and sodium azide.
The Alinity i Rubella IgG Controls are described below:
- Negative Control: Contains recalcified human plasma with protein (ovine) stabilizer. Target concentration: 0.0 IU/mL. Range: = 60 replicates of zero-analyte samples for LoB, n >= 60 replicates of low-analyte level samples for LoD and LoQ.
- Data Source: Not specified beyond "samples".
- Annotation Protocol: Testing conducted using 3 lots of the Alinity i Rubella IgG reagents on each of 2 instruments over a minimum of 3 days.
Linearity
- Sample Size: Not specified.
- Data Source: Not specified.
- Annotation Protocol: Study performed based on guidance from CLSI EP06, 2nd ed.
Analytical Specificity / Interference
- Sample Size: Not specified.
- Data Source: Not specified beyond "samples containing anti-rubella IgG".
- Annotation Protocol: Each substance was evaluated using samples containing anti-rubella IgG at the target ranges of 5.0 to 9.9 IU/mL and 10.0 to 20.0 IU/mL. Guidance from CLSI EP07, 3rd ed., and CLSI EP37, 1st ed.
Potential Cross-Reactivity
- Sample Size: 126 serum specimens.
- Data Source: Specimens from individuals with other medical conditions unrelated to rubella virus, in addition to individual(s) with IgM antibodies to rubella virus.
- Annotation Protocol: Tested for cross-reactivity.
Matrix Equivalency
- Sample Size: 42 donors (29 reactive, 13 nonreactive).
- Data Source: Samples collected in 5 types of blood collection tubes (serum, serum separator, lithium heparin plasma, lithium heparin plasma separator, and tripotassium EDTA plasma).
- Annotation Protocol: Data analyzed using regression analysis comparing concentrations of all matrices to serum.
CDC Panel Agreement
- Sample Size: 82 true positive rubella specimens and 18 true negative rubella specimens (total 100).
- Data Source: Centers for Disease Control and Prevention (CDC) Rubella Reference Sera Panel (collected in 2014).
- Annotation Protocol: The Alinity i Rubella IgG assay results were submitted to the CDC for data analysis and for the result interpretation for each sample.
CDC Low Titer Standard
- Sample Size: Not specified, refers to "CDC Low-Titer Anti-Rubella Human Reference Serum - CDC Biological Standard (catalog number: IS2153 at 21.0 IU/mL)".
- Data Source: CDC biological standard.
- Annotation Protocol: Mean concentration measured for the resuspended standard and a 1:2 dilution.
Clinical Agreement
- Sample Size: 946 (Routine Order US), 457 (Routine Order OUS), 435 (Pregnant Females US), 52 (Supplemental Preselected Negative Pregnant Female US), 59 (Supplemental Preselected Negative Pregnant Females OUS), 135 (Preselected Negative OUS). Total specimens in US category were 1433 samples.
- Data Source: Consecutively collected remnant specimens from individuals (non-pregnant) with a physician's routine order for anti-rubella IgG; specimens from pregnant females.
- Annotation Protocol: Clinical method comparison study based on guidance from CLSI EP12-A2. Results compared to a composite comparator method comprised of 3 FDA-cleared anti-rubella IgG assays. Specimens with initially equivocal results on the comparator device were tested with 2 additional FDA-cleared devices, and the final 2 out of 3 consensus results were used for performance evaluation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Within-Laboratory Precision (20-Day)
- Study Type: Within-laboratory precision study.
- Sample Size: 3 controls and 7 human plasma panels, with 360 replicates for most.
- Standalone Performance:
- Negative Control: Mean 0.0 IU/mL, Overall Within-Laboratory SD 0.06.
- Positive Control 1: Mean 30.4 IU/mL, Overall Within-Laboratory SD 1.50, %CV 4.9.
- Positive Control 2: Mean 342.7 IU/mL, Overall Within-Laboratory SD 21.86, %CV 6.4.
- Panel 1: Mean 0.0 IU/mL, Overall Within-Laboratory SD 0.04.
- Panel 2: Mean 3.0 IU/mL, Overall Within-Laboratory SD 0.24.
- Panel 3: Mean 8.0 IU/mL, Overall Within-Laboratory SD 0.49.
- Panel 4: Mean 12.6 IU/mL, Overall Within-Laboratory SD 0.73, %CV 5.8.
- Panel 5: Mean 25.1 IU/mL, Overall Within-Laboratory SD 1.31, %CV 5.2.
- Panel 6: Mean 234.8 IU/mL, Overall Within-Laboratory SD 14.79, %CV 6.3.
- Panel 7: Mean 398.1 IU/mL, Overall Within-Laboratory SD 31.94, %CV 8.0.
Reproducibility Study (5-Day)
- Study Type: Reproducibility study.
- Sample Size: 3 controls and 7 human plasma panels.
- Key Results: Not all data presented in the text, specific data table incomplete in provided summary.
Lower Limits of Measurement
- Study Type: Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) study.
- Sample Size: n >= 60 replicates for each.
- Key Results:
- LoB: 0.1 IU/mL
- LoD: 0.3 IU/mL
- LoQ: 0.7 IU/mL
Linearity
- Study Type: Linearity study.
- Sample Size: Not specified.
- Key Results: The assay is linear across the analytical measuring interval of 1.0 to 500.0 IU/mL.
Analytical Specificity / Interference
- Study Type: Interference study.
- Sample Size: Not specified.
- Key Results: No significant interference observed for conjugated bilirubin (40 mg/dL), unconjugated bilirubin (40 mg/dL), hemoglobin (1000 mg/dL), total protein (15 g/dL), triglycerides (3000 mg/dL), acetaminophen (250 mg/L), acetylsalicylic Acid (1000 mg/L), ascorbic acid (300 mg/L), biotin (4250 ng/mL), folic acid (100 nmol/L), ibuprofen (500 mg/L).
Potential Cross-Reactivity
- Study Type: Cross-reactivity study.
- Sample Size: 126 serum specimens.
- Key Results: 0 reactive results. 4 grayzone/equivocal results (1 for HAMA, 1 for Human Chorionic Gonadotropin, 1 for Hyper IgG, 1 for Syphilis).
Matrix Equivalency
- Study Type: Matrix equivalency study.
- Sample Size: 42 donors.
- Key Results: All blood collection tube types (serum, serum separator, lithium heparin plasma, lithium heparin plasma separator, and tripotassium EDTA plasma) are acceptable for use. Correlation coefficient (r) of 1.00 for all tested matrices against serum.
CDC Panel Agreement
- Study Type: CDC panel agreement study.
- Sample Size: 100 (82 true positive, 18 true negative).
- Key Results:
- Positive Percent Agreement (PPA): 93.9% (77/82) with 95% CI of 86.51% to 97.37%.
- Negative Percent Agreement (NPA): 100.0% (18/18) with 95% CI of 82.41% to 100.00%.
CDC Low Titer Standard
- Study Type: Low titer standard detection verification.
- Sample Size: Not specified.
- Key Results: Mean concentration of 18.2 IU/mL for resuspended CDC low titer standard and 8.6 IU/mL for 1:2 dilution.
Clinical Agreement
- Study Type: Clinical method comparison study.
- Sample Size: 946 (Routine Order US), 457 (Routine Order OUS), 435 (Pregnant Females US), 52 (Supplemental Preselected Negative Pregnant Female US), 59 (Supplemental Preselected Negative Pregnant Females OUS), 135 (Preselected Negative OUS).
- Key Results (comparing to a composite comparator method with 3x3 table interpretation, using Alinity i Rubella IgG interpretation: Reactive: >=10.0 IU/mL, Grayzone/Equivocal: 5.0 to =10.0 IU/mL for positive and
§ 866.3510 Rubella virus serological reagents.
(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.
FDA 510(k) Clearance Letter - Alinity i Rubella IgG
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 20, 2025
Abbott Laboratories
Laura Fraczek
Regulatory Affairs Senior Specialist
100 Abbott Park Road
Abbott Park, Illinois 60064
Re: K243168
Trade/Device Name: Alinity i Rubella IgG
Regulation Number: 21 CFR 866.3510
Regulation Name: Rubella Virus Serological Reagents
Regulatory Class: Class II
Product Code: LFX
Dated: May 22, 2025
Received: May 22, 2025
Dear Laura Fraczek:
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 (the 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 available 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.
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K243168 - Laura Fraczek Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K243168 - Laura Fraczek Page 3
assistance/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,
Jorge L. Munoz, Ph.D.
Deputy Branch Chief
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K243168
Device Name
Alinity i Rubella IgG
Indications for Use (Describe)
The Alinity i Rubella IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of IgG antibodies to rubella virus in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the Alinity i system.
The Alinity i Rubella IgG assay is to be used as an aid in the determination of immune status to rubella in individuals including women of child-bearing age.
The Alinity i Rubella IgG assay has not been cleared for use in screening blood, plasma, or tissue donors.
The performance of this device has not been established for cord blood or neonatal samples. Likewise, performance has not been established for populations of immunocompromised or immunosuppressed individuals.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1
Page 5
Alinity i Rubella IgG K243168
510(k) Summary
Page 1 of 18
510(k) Summary
This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
I. 510(k) Number
II. Applicant Name
Abbott Laboratories
Department 09AA
100 Abbott Park Road
Abbott Park, IL 60064
Primary contact person for all communications:
Laura Fraczek, Regulatory Affairs Manager
Abbott Diagnostics Division
Telephone Number: (224) 668-8852
Fax Number: (224) 667-4836
Secondary contact person for all communications:
Jacob Richards, Associate Director, Regulatory Affairs
Abbott Diagnostic Division
Telephone Number: (224) 668-5877
Fax Number: (224) 667-4836
Date summary prepared: June 19, 2025
Page 6
Alinity i Rubella IgG K243168
510(k) Summary
Page 2 of 18
III. Device Name
Alinity i Rubella IgG
Reagents
Trade Name: Alinity i Rubella IgG Reagent Kit
Device Classification: Class II
Classification Name: Rubella virus serological reagents
Governing Regulation: 21 CFR 866.3510
Code: LFX
Calibrator
Trade Name: Alinity i Rubella IgG Calibrators
Device Classification: Class II
Classification Name: Rubella virus serological reagents
Governing Regulation: 21 CFR 866.3510
Code: LFX
Controls
Trade Name: Alinity i Rubella IgG Controls
Device Classification: Class II
Classification Name: Rubella virus serological reagents
Governing Regulation: 21 CFR 866.3510
Code: LFX
IV. Predicate Device
bioMérieux VIDAS RUB IgG assay (K080766)
V. Description of Device
Reagents
The kit configuration of the Alinity i Rubella IgG Reagent Kit is described below.
| List Number (LN) | 04W0222 |
|---|---|
| Tests per cartridge | 100 |
| Number of cartridges per kit | 2 |
| Tests per kit | 200 |
| Microparticles | 6.6 mL |
| Conjugate | 6.1 mL |
| Assay Diluent | 10.4 mL |
Page 7
Alinity i Rubella IgG K243168
510(k) Summary
Page 3 of 18
-
Microparticles: Partially purified rubella virus coated microparticles in TRIS buffer with surfactant. Minimum concentration: 0.12% solids. Preservatives: ProClin 950 and sodium azide.
-
Conjugate: Anti-human IgG (mouse, monoclonal) acridinium-labeled conjugate in MES buffer with protein (bovine) stabilizer and surfactant. Minimum concentration: 16 ng/mL. Preservatives: antimicrobial agents.
-
Assay Diluent: TRIS buffer with protein (caprine, bovine, murine) stabilizers and surfactant. Preservatives: ProClin 300 and ProClin 950.
Calibrators
The Alinity i Rubella IgG Calibrators are described below.
-
Calibrator A: Contains recalcified human plasma with protein (ovine) stabilizer.
-
Calibrator B – F: Contain recalcified human plasma (reactive for IgG antibodies to rubella virus [anti-rubella IgG]) with protein (ovine) stabilizer.
-
Preservatives: ProClin 950 and sodium azide.
The target concentrations for the calibrators are provided in the following table.
| Calibrator | Quantity | Anti-Rubella IgG Concentration (IU/mL) |
|---|---|---|
| Calibrator A | 1 x 3.0 mL | 0.0 |
| Calibrator B | 1 x 3.0 mL | 5.5 |
| Calibrator C | 1 x 3.0 mL | 16.5 |
| Calibrator D | 1 x 3.0 mL | 82.5 |
| Calibrator E | 1 x 3.0 mL | 275.0 |
| Calibrator F | 1 x 3.0 mL | 550.0 |
The Alinity i Rubella IgG Calibrator B through F are referenced to the World Health Organization (WHO) International Standard (RUBI-1-94) for Anti-Rubella Immunoglobulin at each concentration level.
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Alinity i Rubella IgG K243168
510(k) Summary
Page 4 of 18
Controls
The Alinity i Rubella IgG Controls are described below.
-
Negative Control: Contains recalcified human plasma with protein (ovine) stabilizer.
-
Positive Control 1 and 2: Contain recalcified human plasma (reactive for anti-rubella IgG) with protein (ovine) stabilizer.
-
Preservatives: ProClin 950 and sodium azide.
The target concentrations and ranges for the controls are provided in the table below.
| Control | Quantity | Anti-Rubella IgG Concentration (IU/mL) | Range (IU/mL) |
|---|---|---|---|
| Negative Control | 1 x 8.0 mL | 0.0 |