The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.

Device Description

The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative detection of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems.

The Access Rubella IgG assay consists of the reagent pack, calibrators, and quality controls (QCs), packaged separately. Other items needed to run the assay include substrate and wash buffer.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - Access Rubella IgG

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

November 17, 2025

Beckman Coulter Inc.
Audree Demmers
Director Quality Assurance
1000 Lake Hazeltine Drive
Chaska, Minnesota 55318

Re: K250588
Trade/Device Name: Access Rubella IgG
Regulation Number: 21 CFR 866.3510
Regulation Name: Rubella Virus Serological Reagents
Regulatory Class: Class II
Product Code: LFX
Dated: October 14, 2025
Received: October 15, 2025

Dear Audree Demmers:

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.

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"

Page 2

K250588 - Audree Demmers Page 2

(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-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).

Page 3

K250588 - Audree Demmers Page 3

Sincerely,

JORGE L. MUNOZ -S
Digitally signed by JORGE L. MUNOZ -S
Date: 2025.11.17 16:37:38 -04'00'

Jorge 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

FORM FDA 3881 (8/23) Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K250588

Device Name: Access Rubella IgG

Indications for Use (Describe):

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."

Page 5

Rubella IgG 510(k)

510 (k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K250588

Submitted By:

Beckman Coulter, Inc.
1000 Lake Hazeltine Drive
Chaska, MN 55318

Primary Contact:

Audree Demmers
Director Quality Assurance
Phone: (651) 605-5278
Email: aldemmers@beckman.com

Alternate Contact:

Kate Oelberg
Senior Staff Quality and Regulatory Affairs
Phone: (612) 431-7315
Email: kmoelberg@beckman.com

Regulatory Information

Regulation Number: 21 CFR 866.3510
Regulation Description: Rubella Virus Serological Reagents
Device Trade Name: Access Rubella IgG
Product Classification Name: Enzyme Linked Immunoabsorbent Assay, Rubella
Classification Code: LFX
Device Class: II

Predicate Device

Device Name: Access Rubella IgG
510(k) Numbers: K954687

Device Description

The Access Rubella IgG assay consists of the reagent pack, calibrators, and quality controls (QCs), packaged separately. Other items needed to run the assay include substrate and wash buffer.

Page 6

Intended Use

Comparison with Predicate(s)

Device & Predicate Device(s):	Candidate Test K250588	Predicate K954687
Device Trade Name	Same	Access Rubella IgG
General Device Characteristic Similarities
Intended Use/Indications For Use	Same	The Access Rubella IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.
Analyte	Same	IgG antibody to rubella virus
Technology	Same	Two-step immunoenzymatic assay
Format	Same	Chemiluminescent
Method	Same	Automated

Page 7

Device & Predicate Device(s):	Candidate Test K250588	Predicate K954687
Calibration	Same	Utilizes a stored calibration curve
Calibration Frequency	Same	28 days
Sample Type	Same	Serum
Results Interpretation	Same	<10.0 IU/mL: Non-Reactive≥10 - <15 IU/mL: Equivocal≥15.0 IU/mL: Reactive
Capture Reagent	Same	Paramagnetic particles coated with rubella (strain HPV 77) sucrose gradient purified antigen
Detection Antibody	Same	Mouse monoclonal anti-human IgG antibody (clone 125 A 15) - alkaline phosphatase (bovine) conjugate
Stability	Same	28 days after opening, 2 -10°C
General Device Characteristic Differences
Analytical Measuring Interval	5.0 – 500 IU/mL	10.0 – 500 IU/mL
Substrate	Lumi-Phos PRO substrate	Access Substrate
Instrument	DxI 9000 Access Immunoassay Analyzer	Access 2 Immunoassay System

Standard/Guidance Document Referenced (if applicable):

CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Third Edition
CLSI EP06-2nd Edition: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition
CLSI EP09c 3rd Edition: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Third Edition

Page 8

CLSI EP12-Ed3, Evaluation of Qualitative, Binary Output Examination Performance, Third Edition.

Summary of Studies

Method Comparison: Comparison of Access Rubella IgG assay on the Access 2 Immunoassay System to the DxI 9000 Access Immunoassay Analyzer

A method comparison of 162 native serum samples using the Access Rubella IgG assay on the DxI 9000 Access Immunoassay Analyzer and the Access 2 Immunoassay System was conducted to compare the performance on both systems. Positive percent agreement (PPA) and negative percent agreement (NPA) between the Access Rubella IgG assay run on the DxI 9000 Immunoassay Analyzer and the Access 2 Immunoassay System was calculated for the Access Rubella IgG assay and are shown in Table 1.

Table 1: Performance Agreement of Access Rubella IgG assay on the Access 2 Immunoassay System and the DxI 9000 Immunoassay Analyzer (n=162)

Access Rubella IgG	Access 2 Immunoassay System
	Reactive	Equivocal	Non-Reactive	Total
DxI 9000 Immunoassay Analyzer
Reactive	77	0	0	77
Equivocal	0	25	2	27
Non-Reactive	0	2	56	58
Total	77	27	58	162

PPAᵃ 97.47% (77/79), 95% CI = 91.23% to 99.30%
NPAᵇ 96.55% (56/58), 95% CI = 88.27% to 99.05%

ᵃ'ᵇ 95% CI for PPA and NPA were estimated using the Wilson score method.

Imprecision:

The assay was designed to have within-laboratory imprecision as listed below:

≤ 2.25 IU/mL SD at concentrations < 15 IU/mL
≤ 15.0% CV at concentrations ≥ 15 IU/mL

a) Within-Laboratory Precision: A study based on CLSI EP05-A3 performed on the DxI 9000 Access Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for

Page 9

20 days. Six serum samples were tested using 3 reagent lot/calibrator lot combinations. The data were analyzed for repeatability (within-run), between-run, between-day, between lot and instrument and overall precision. Within-laboratory precision data summary is shown in Table 2.

Table 2: Access Rubella IgG assay 20-day Within-Laboratory Precision on the DxI 9000 Access Immunoassay Analyzer.

Sample	n	Mean (IU/mL)	Repeatability (Within-Run)	Between-Run	Between-Day	Between Instrument/ Reagent Lot/ Calibrator Lotᵃ	Overall Precision ᵇ
			SD	%CV	SD	%CV	SD
Sample 1	240	10.6	0.38	3.6	0.29	2.7	0.47
Sample 2	240	19.2	0.78	4.0	0.69	3.6	0.91
Sample 3	240	59.9	3.09	5.2	2.43	4.0	1.99
Sample 4	240	120.7	4.69	3.9	3.89	3.2	6.69
Sample 5	240	164.5	5.99	3.6	6.96	4.2	0.00
Sample 6	240	379.4	14.36	3.8	8.75	2.3	19.23

ᵃ Access Rubella IgG reagent lot, Access Rubella IgG calibrator lot, and DxI 9000 instrument are confounded, and the confounding effect is represented by Between-Instrument/Reagent Lot/Calibrator Lot.
ᵇ Overall within-laboratory variability includes within-run, between-run, between-day, and between-lot variance components.

c) Reproducibility (between-Instrument Precision): A reproducibility study based on CLSI EP05-A316 performed on the DxI 9000 Access Immunoassay Analyzer tested multiple samples in replicates of 5 in 1 run per day for a minimum of 5 days. The study tested 6 serum samples with the Access Rubella IgG on 3 DxI 9000 Access Immunoassay Analyzers in an internal site. The samples were tested with 3 lots of Access Rubella IgG reagents, and 1 lot of Access Rubella IgG calibrator on each instrument. Summary of the data is shown in Table 3.

Table 3: Access Rubella IgG Assay assay Reproducibility on the DxI 9000 Access Immunoassay Analyzer

Sample	n	Mean (IU/mL)	Repeatability (Within-Run)	Between-Day/Runᵃ	Between-Instrument	Between-Lot	Reproducibilityᵇ
			SD	%CV	SD	%CV	SD
Sample 1	225	10.5	0.40	3.8	0.55	5.2	0.04
Sample 2	225	18.4	0.82	4.4	0.76	4.1	0.43
Sample 3	225	58.3	2.85	4.9	3.82	6.6	2.16
Sample 4	225	119.7	5.18	4.3	7.64	6.4	0.00
Sample 5	225	162.8	6.44	4.0	9.74	6.0	4.26
Sample 6	225	370.9	13.38	3.6	18.13	4.9	5.76

Page 10

ᵃ Days and runs are confounded.
ᵇ Reproducibility includes within-run, between-run, between-day, and between-lot variance components.

Linearity: A study based on CLSI EP06-Ed2 performed with the Access Rubella IgG assay on the DxI 9000 Access Immunoassay Analyzer determined the assay demonstrated linearity across the measuring interval of 5.0 – 500 IU/mL.

Limit of Blank (LoB): The observed LoB for Access Rubella IgG assay on the DxI 9000 Access Immunoassay Analyzer is 0.1 IU/mL.

Limit of Detection (LoD): The observed LoD for Access Rubella IgG assay on the DxI 9000 Access Immunoassay Analyzer is 0.2 IU/mL.

Limit of Quantitation (LoQ): The claimed LoQ for Access Rubella IgG assay on the DxI 9000 Access Immunoassay Analyzer is 5.0 IU/mL.

Substantial Equivalence Comparison Conclusion

Beckman Coulter's Access Rubella IgG Assay on the DxI 9000 Access Immunoassay Analyzer is substantially equivalent to the Access Rubella IgG Assay on the Access 2 Immunoassay System as demonstrated through the information and data provided in this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.

Regulation Number and Section

§ 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.