Access hsTnI

K222881 · Beckman Coulter, Inc. · MMI · Dec 18, 2023 · Clinical Chemistry

Device Facts

• Record ID: K222881
• Device Name: Access hsTnI
• Applicant: Beckman Coulter, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Dec 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

Access hsTnl is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Dxl Access Immunoassay Analyzers to aid in the diagnosis of myocardial infarction (MI).

Device Story

Access hsTnI is a sandwich immunoenzymatic assay using paramagnetic particles and chemiluminescence; designed for use on the DxI 9000 Access Immunoassay Analyzer in clinical laboratory settings. The device processes human serum or plasma samples to quantify cardiac troponin I (cTnI) levels. The assay utilizes mouse monoclonal anti-human cTnI antibody and sheep monoclonal anti-human cTnI detection antibody. Results are provided to clinicians to aid in the diagnosis of myocardial infarction. The device benefits patients by providing high-sensitivity quantitative data for rapid cardiac assessment.

Clinical Evidence

Bench testing only. Precision/reproducibility studies (CLSI EP05-A3) were conducted on the DxI 9000 analyzer using serum and lithium heparin plasma, demonstrating acceptable SD and %CV across the measuring range. Linearity (CLSI EP06-A2) and detection limits (LoB, LoD, LoQ per CLSI EP17-A2) were verified. Method comparison (N=184 plasma, N=328 serum) against the predicate (Access 2 analyzer) showed high correlation (R=0.999 and 0.998 respectively). Thermal imprecision and matrix comparison studies confirmed performance stability.

Technological Characteristics

Sandwich immunoenzymatic assay; paramagnetic particle, chemiluminescent detection. Reagents: mouse monoclonal anti-human cTnI antibody and sheep monoclonal anti-human cTnI. Instrument: DxI 9000 Access Immunoassay Analyzer. Substrate: Lumi-Phos PRO. Analytical measuring range: 2.0 pg/mL to 27,027 pg/mL. Automated dilution up to 270,270 pg/mL. Open reagent pack stability: 64 days at 2-10°C.

Indications for Use

Indicated for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma to aid in the diagnosis of myocardial infarction (MI).

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Predicate Devices

• Access hsTnl (K172787)

Submission Summary (Full Text)

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December 18, 2023

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

Re: K222881

Trade/Device Name: Access hsTnI Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: August 3, 2023 Received: August 3, 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 (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" (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).

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Your device is also subject to, among other requirements, the Quality System (OS) 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 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-safetyreporting-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.

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-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 Division 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

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## Indications for Use

510(k) Number (if known) k222881

Device Name Access hsTnI

Indications for Use (Describe)

Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the DxI Access Immunoassay Analyzers to aid in the diagnosis of myocardial infarction (MI).

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) |

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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, resembling a stylized wave or ribbon. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked vertically, with "BECKMAN" on top and "COULTER" below, both in a bold, sans-serif font.

### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a)(1).

The assigned 510(k) number is k222881

#### Submitted By:

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

#### Contact Person:

Kate Oelberg 1000 Lake Hazeltine Drive Chaska, MN 55318 Phone: [phone] Email: [e-mail]

#### Alternate Contact:

Stephanie Garth Office Phone: [phone] Email: [e-mail]

Trade Name: Access hsTnl Common Name: Troponin | Enzyme Immunoassay Classification Requlation: 21 CFR 862.1215 Classification Product Code: MMI

Predicate Devices: Access hsTnl, FDA 510(k) Number K172787

#### Device Description

The Access hsTnl assay is a sandwich immunoenzymatic assay. The Access hsTnl assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access hsTnl reagent pack, Access hsTnl 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

Access hsTnl is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Dxl Access Immunoassay Analyzers to aid in the diagnosis of myocardial infarction (MI).

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| Comparison of Technological Characteristics to the Predicate (Assay) | | |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicate Access hsTnl on Access 2 Immunoassay System | Access hsTnl for Dxl 9000 Access Immunoassay Analyzer |
| Intended Use/ Indications for Use | Access hsTnl is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI). | Access hsTnl is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Dxl Access Immunoassay Analyzers to aid in the diagnosis of myocardial infarction (MI). |
| Technology | Sandwich | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Sample Type | Serum and lithium heparin plasma | Same |
| Analytical Measuring Range | 2.0 pg/mL to 27,027 pg/mL | Same |
| Automated Dilution (Dilution Recovery) | Up to approximately 270,270 pg/mL | Same |
| Expected Results (Upper Reference Limit) | 99th percentile of 17.5 pg/ mL with a 95% Confidence Interval (CI) of 12.6 - 20.7 pg/mL for plasma and 18.2 pg/mL with a 95% Confidence Interval (CI) of 13.1-23.1 pg/mL for serum. | Same |
| Precision | ≤ 10% within-laboratory CV for concentrations ≥ 11.5 pg/mL ≤ 1.15 pg/mL within laboratory SD for concentrations < 11.5 pg/mL | Same |
| Primary Reagent Materials | Mouse monoclonal anti-human cTnl antibody; detection is Sheep monoclonal anti-human cTnl | Same |
| Open Reagent Pack Stability | Stable at 2 to 10°C for 64 days after opening | Same |
| Reagent Pack configuration | Reagents ready to use and separated in a single reagent pack | Same |
| Assay Protocol File (APF) | hsTnl APF with no thermal algorithm | Same |
| Immunoassay Instrument | Access 2 Immunoassay system | Dxl 9000 Access Immunoassay Analyzer |
| Substrate | Access Substrate | Lumi-Phos PRO substrate |

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Clinical performance: A study based on CLSI EP09c, 3rd Edition using Passing-Bablok regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer. The results of the method comparison study met the acceptance criteria of slope 1.00 ± 0.10 and supports the equivalence of the Access hsTnl on Dxl 9000 to the Access hsTnl on Dxl 9000 Access Immunoassay Analyzer for both lithium heparin plasma and serum samples.

lmprecision: The within-laboratory (total) % CV ranged from 2.3% to 6.4% for serum samples and 1.7% to 4.4% for plasma samples, for hsTnl concentrations ≥ 11.5 pg/mL. The withinlaboratory (total) SD ranged from 0.17 to 0.33 for serum samples and 0.17 to 0.40 for plasma samples with hsTnl concentrations < 11.5 pg/mL.

Linearity: This study shows that the acceptance criteria was met for non-linearity within ± 10% for values ≥11.5 pg/mL and ± 1.15 pg/mL for values < 11.5 pg/mL.

LoB/LoD: The data demonstrated the LoB estimate of the Access hsTnl is 0.5 pg/mL and the LoD estimate are 0.9 pg/mL (serum) and 0.8 pg/mL(plasma).

LoQ: The LoQ for Access hsTnl at ≤20% with-in lab CV was determined to be 1.0 pg/mL (serum) and 0.8 pq/mL (plasma).

Carryover: No clinically significant carryover for ≥95% of high samples tested up to 270,000 pg/mL (ng/L), based on a concentration shift of <3.5 pg/mL (ng/L) when testing a low sample (≤10 pg/mL [ng/L]).

#### Substantial Equivalence Comparison Conclusion

The information provided in this submission supports a substantial equivalence determination. and therefore 510(k) premarket notification clearance of the Access hsTnl on Dxl 9000 Access Immunoassay Analyzer.