Access Myoglobin

K231832 · Beckman Coulter, Inc. · DDR · Sep 18, 2023 · Immunology

Device Facts

• Record ID: K231832
• Device Name: Access Myoglobin
• Applicant: Beckman Coulter, Inc.
• Product Code: DDR · Immunology
• Decision Date: Sep 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems. Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.

Device Story

Access Myoglobin is a sandwich immunoenzymatic assay used in clinical laboratories to measure myoglobin levels in human serum or plasma. The device utilizes paramagnetic particles and a chemiluminescent detection system. A sample is reacted with mouse monoclonal anti-myoglobin-alkaline phosphatase conjugate, mouse monoclonal anti-myoglobin-biotin conjugate, and paramagnetic particles coated with goat anti-biotin. The system measures light production from a chemiluminescent reaction, which is proportional to the myoglobin concentration in the sample. The assay is performed on the Dxl 9000 Access Immunoassay Analyzer. Healthcare providers use the quantitative results to assist in diagnosing heart or renal disease. The device provides a standardized diagnostic measurement, aiding clinical decision-making by identifying elevated myoglobin levels associated with cardiac or renal pathology.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A3 (N=80 replicates per sample). Linearity assessed per CLSI EP06-2nd Edition. Limit of Blank (0.3 ng/mL), Limit of Detection (0.8 ng/mL), and Limit of Quantitation (1.0 ng/mL) determined per CLSI EP17-A2. Method comparison study (N=155) against predicate device yielded slope of 0.99 and R=1.00. Matrix comparison studies (LiHep vs. Serum/EDTA) confirmed equivalence across sample types.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Sandwich immunoenzymatic principle. Detection via dioxetane-based chemiluminescent substrate (Lumi-Phos PRO). Measuring range 3.0–4000 ng/mL. Sample types: serum, heparin plasma, EDTA plasma. Instrument: Dxl 9000 Access Immunoassay Analyzer. Standards: CLSI EP05-A3, EP06-2nd Ed, EP17-A2, EP09c, EP28-A3c, EP35.

Indications for Use

Indicated for the quantitative determination of myoglobin in human serum and plasma to aid in the diagnosis of heart and renal diseases. For prescription use only in clinical laboratory settings.

Regulatory Classification

Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Predicate Devices

• Myoglobin And Myoglobin Calibrators On The Access Immunoassay System (K021229)

Submission Summary (Full Text)

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September 18, 2023

Beckman Coulter, Inc. Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318

Re: K231832

Trade/Device Name: Access Myoglobin Regulation Number: 21 CFR 866.5680 Regulation Name: Myoglobin Immunological Test System Regulatory Class: Class II Product Code: DDR Dated: June 21, 2023 Received: June 22, 2023

Dear Kate Oelberg:

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 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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) k231832

Device Name Access Myoglobin

Indications for Use (Describe)

The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of heart or renal disease.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 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 k231832

#### Submitter Name and Address:

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

#### Primary Contact:

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

### Alternate Contact:

Kuljeet Kaur, Requlatory Affairs Manager Email: [e-mail] Office Phone: [phone]

Trade Name: Access Myoglobin Common Name: Myoqlobin Classification Regulation: 21 CFR 866.5680 Classification Product Code: DDR

### Predicate Device:

Access Myoglobin 510(k) Number K021229

#### Device Description

The Access Myoglobin assay is a sandwich immunoenzymatic assay. The Access Myoglobin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Myoqlobin assay reagent pack, Access Myoqlobin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

### Intended Use

The Access Myodobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of heart or renal disease.

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# Comparison of Technological Characteristics to the Predicate (Assay)

| System<br>Attribute/Characteristic | Predicate Access Myoglobin<br>assay (k021229) run on the<br>Access 2 Immunoassay<br>System | Access Myoglobin assay run<br>on the Dxl 9000 Access<br>Immunoassay Analyzer<br>Instrument |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Intended Use/<br>Indications for Use | The Access Myoglobin assay<br>is a paramagnetic particle,<br>chemiluminescent<br>immunoassay for the<br>quantitative<br>determination of myoglobin<br>levels in human serum and<br>plasma using the Access<br>Immunoassay Systems. | Same |
| Assay Principles | The Access Myoglobin assay<br>is a two-site immunoenzymatic<br>("sandwich") assay. A sample<br>is added to a reaction vessel<br>with mouse monoclonal anti-<br>myoglobin-alkaline<br>phosphatase conjugate,<br>mouse monoclonal anti-<br>myoglobin-biotin<br>conjugate, and paramagnetic<br>particles coated with goat anti-<br>biotin. | Same |
| Solid Support | Paramagnetic Particles | Same |
| Detection System | Utilizes dioxetane-based<br>chemiluminescent substrate;<br>Measures light production from<br>a chemiluminescent reaction | Same |
| Calibrators | Liquid calibrators prepared<br>from buffered bovine protein<br>matrix and human skeletal<br>Myoglobin at various levels | Same |
| Sample Type | Serum/Plasma (heparin or<br>EDTA) | Same |
| Measuring Range | 1 - 4000 ng/mL | 3.0 - 4000 ng/mL |
| Expected Results | Separate ranges for Heparin<br>plasma/serum vs EDTA<br>plasma | Same ranges |
| Instrument | Access Immunoassay system | Dxl 9000 Access<br>Immunoassay Analyzer |
| Substrate | Access Substrate | Lumi-Phos PRO substrate |

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# 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: Measurement Procedure Comparison and Bias Estimation Using Patient Samples-Third Edition

CLSI EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory - Third Edition

CLSI EP35 Assessment of Equivalence of Suitability of Specimen Types for Medical Laboratory Measurement Procedures - First Edition

# Summary of Studies:

Method Comparison:_A study based on CLSI EP09c, 3rd Edition using Weighted Deming regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.

| N | Concentratio<br>n Range*<br>(ng/mL) | Slope | Slope<br>95% CI | Intercept | Intercept<br>95% CI | R |
|-----|-------------------------------------|-------|-----------------|-----------|---------------------|------|
| 155 | 8.2 – 3900 | 0.99 | 0.98 – 1.00 | 0.47 | -0.10 – 1.0 | 1.00 |

*Range is Access 2 values

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

≤ 1.10 ng/mL (µg/L) SD at concentrations ≤ 11.0 ng/mL (µg/L)

≤ 10.0% CV at concentrations > 11.0 ng/mL (uq/L)

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 a minimum of 20 days.

| ng/mL (µg/L) | | Repeatability<br>(Within-Run) | | Between-Run | | Between-Day | | Within-<br>Laboratory | | |
|--------------|----|-------------------------------|------|-------------|------|-------------|------|-----------------------|-------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 80 | 7.9 | 0.18 | 2.3 | 0.18 | 2.2 | 0.17 | 2.2 | 0.31 | 3.9 |
| Sample 2 | 80 | 101 | 2.2 | 2.1 | 4.0 | 4.0 | 3.0 | 3.0 | 5.5 | 5.4 |
| Sample 3 | 80 | 465 | 8.0 | 1.7 | 15.1 | 3.2 | 0.0 | 0.0 | 17.0 | 3.7 |
| Sample 4 | 80 | 1763 | 35.0 | 2.0 | 57.5 | 3.3 | 0.1 | 0.0 | 67.3 | 3.8 |
| Sample 5 | 80 | 2719 | 54.8 | 2.0 | 85.9 | 3.2 | 0.0 | 0.0 | 101.9 | 3.7 |

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Linearity: A study based on CLSI EP06-Ed2 performed on the Dxl 9000 Access Immunoassay Analyzer determined the assay demonstrated linearity across the measuring interval.

Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ): Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies were conducted on the Dxl 9000 Access Immunoassay Analyzer following CLSI guideline EP17-A2 The LoB study included multiple reagent lots and 3 instruments over a minimum of 3 days. The LoD and LoQ studies included multiple reagent lots and 3 instruments over a minimum of 5 days.

| | ng/mL (μg/L) |
|----------------------------------------------------|--------------|
| Limit of Blank (LoB) | 3.0 |
| Limit of Detection (LoD) | 3.0 |
| Limit of Quantitation (LoQ)<br>≤ 20% within-lab CV | 3.0 |

# Substantial Equivalence Comparison Conclusion

Beckman Coulter's Access Myoglobin assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to Myoglobin assay on the Access Immunoassay System (k021229) 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.