Access Rubella IgG

K250588 · Beckman Coulter, Inc. · LFX · Nov 17, 2025 · Microbiology

Device Facts

• Record ID: K250588
• Device Name: Access Rubella IgG
• Applicant: Beckman Coulter, Inc.
• Product Code: LFX · Microbiology
• Decision Date: Nov 17, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Intended Use

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 Story

Access Rubella IgG is a paramagnetic-particle, chemiluminescent immunoassay; detects IgG antibodies to rubella virus in human serum. Operates on DxI 9000 Access Immunoassay Analyzer; utilizes two-step immunoenzymatic assay principle. Capture reagent: paramagnetic particles coated with rubella (strain HPV 77) antigen; detection antibody: mouse monoclonal anti-human IgG conjugated to alkaline phosphatase. Instrument automates sample processing, incubation, and chemiluminescent signal measurement. Output: qualitative/quantitative results (IU/mL) interpreted as Non-Reactive, Equivocal, or Reactive. Used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing rubella infection and assessing patient immune status.

Clinical Evidence

Bench testing only. Precision studies (within-laboratory and between-instrument) were conducted over 20 and 5 days respectively, showing acceptable variability. Linearity was confirmed across the 5.0–500.0 IU/mL range. A method comparison study (n=162) between the DxI 9000 and the predicate Access 2 system demonstrated a PPA of 97.47% and NPA of 96.55%. No new clinical studies were performed; clinical agreement relies on the predicate device.

Technological Characteristics

Paramagnetic-particle, chemiluminescent immunoassay. Capture: rubella (strain HPV 77) antigen-coated particles. Detection: mouse monoclonal anti-human IgG-alkaline phosphatase conjugate. Automated system (DxI 9000). Measuring interval: 5.0–500 IU/mL. Standards: CLSI EP05-A3, EP06, EP17-A2, EP09c, EP12.

Indications for Use

Indicated for qualitative and quantitative determination of IgG antibodies to rubella virus in human serum to aid in diagnosis of rubella infection and determination of immunity.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Access Rubella IgG (K954687)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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"

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

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K250588 - Audree Demmers
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(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 ([e-mail]) or phone [phone] or 301-796-7100).

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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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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) 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. | |
| 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 [e-mail] | |
| "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." | |

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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.

## Submitted By:
Beckman Coulter, Inc.
1000 Lake Hazeltine Drive
Chaska, MN 55318

## Primary Contact:
Audree Demmers
Director Quality Assurance
Phone: [phone]
Email: [e-mail]

## Alternate Contact:
Kate Oelberg
Senior Staff Quality and Regulatory Affairs
Phone: [phone]
Email: [e-mail]

## 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 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.

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# Intended Use

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.

## 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 |

Rubella IgG 510(k)

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| 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

Rubella IgG 510(k)

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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 Dxl 9000 Access Immunoassay Analyzer

A method comparison of 162 native serum samples using the Access Rubella IgG assay on the Dxl 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 Dxl 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 Dxl 9000 Immunoassay Analyzer (n=162)

| Access Rubella IgG | Access 2 Immunoassay System | | | | |
| --- | --- | --- | --- | --- | --- |
| | | Reactive | Equivocal | Non-Reactive | Total |
| Dxl 9000 Immunoassay Analyzer | Reactive | 77 | 0 | 0 | 77 |
| | Equivocal | 0 | 25 | 2 | 27 |
| | Non-Reactive | 0 | 2 | 56 | 58 |
| | Total | 77 | 27 | 58 | 162 |
| | PPA^{a} | 97.47% (77/79), 95% CI = 91.23% to 99.30% | | | |
| | NPA^{b} | 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 &lt; 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 Dxl 9000 Access Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for

Rubella IgG 510(k)

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20 days. Six serum samples were tested using 3 reagent lot/calibrator lot combinations. The

b) 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 Dxl 9000 Access Immunoassay Analyzer.

| Sample | n | Mean (IU/mL) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Between Instrument/ Reagent Lot/ Calibrator Lota | | Overall Precisionb | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 240 | 10.6 | 0.38 | 3.6 | 0.29 | 2.7 | 0.47 | 4.4 | 0.33 | 3.2 | 0.75 | 7.0 |
| Sample 2 | 240 | 19.2 | 0.78 | 4.0 | 0.69 | 3.6 | 0.91 | 4.7 | 0.19 | 1.0 | 1.39 | 7.3 |
| Sample 3 | 240 | 59.9 | 3.09 | 5.2 | 2.43 | 4.0 | 1.99 | 3.3 | 1.10 | 1.8 | 4.54 | 7.6 |
| Sample 4 | 240 | 120.7 | 4.69 | 3.9 | 3.89 | 3.2 | 6.69 | 5.5 | 2.82 | 2.3 | 9.48 | 7.9 |
| Sample 5 | 240 | 164.5 | 5.99 | 3.6 | 6.96 | 4.2 | 0.00 | 0.0 | 1.35 | 0.8 | 9.29 | 5.6 |
| Sample 6 | 240 | 379.4 | 14.36 | 3.8 | 8.75 | 2.3 | 19.23 | 5.1 | 9.75 | 2.6 | 27.35 | 7.2 |

a Access Rubella IgG reagent lot, Access Rubella IgG calibrator lot, and Dxl 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 Dxl 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 Dxl 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 Dxl 9000 Access Immunoassay Analyzer

| Sample | n | Mean (IU/mL) | Repeatability (Within-Run) | | Between-Day/Run\(^a\) | | Between-Instrument | | Between-Lot | | Reproducibility\(^b\) | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 225 | 10.5 | 0.40 | 3.8 | 0.55 | 5.2 | 0.04 | 0.3 | 0.31 | 3.0 | 0.75 | 7.1 |
| Sample 2 | 225 | 18.4 | 0.82 | 4.4 | 0.76 | 4.1 | 0.43 | 2.3 | 0.14 | 0.8 | 1.20 | 6.5 |
| Sample 3 | 225 | 58.3 | 2.85 | 4.9 | 3.82 | 6.6 | 2.16 | 3.7 | 3.70 | 6.3 | 6.41 | 11.0 |
| Sample 4 | 225 | 119.7 | 5.18 | 4.3 | 7.64 | 6.4 | 0.00 | 0.0 | 3.55 | 3.0 | 9.90 | 8.3 |
| Sample 5 | 225 | 162.8 | 6.44 | 4.0 | 9.74 | 6.0 | 4.26 | 2.6 | 5.53 | 3.4 | 13.61 | 8.4 |
| Sample 6 | 225 | 370.9 | 13.38 | 3.6 | 18.13 | 4.9 | 5.76 | 1.6 | 7.21 | 1.9 | 24.35 | 6.6 |

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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 Dxl 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 Dxl 9000 Access Immunoassay Analyzer is 0.1 IU/mL.

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

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

## Substantial Equivalence Comparison Conclusion

Beckman Coulter's Access Rubella IgG Assay on the Dxl 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.

Rubella IgG 510(k)