Who is the manufacturer of Access hsTnI?

Beckman Coulter, Inc. filed the 510(k) submission for Access hsTnI (K230648).

What is the FDA product code for Access hsTnI?

MMI. It is classified under 21 CFR 862.1215 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for Access hsTnI?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Access hsTnI?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Access hsTnI

K230648 · Beckman Coulter, Inc. · MMI · Dec 4, 2023 · Clinical Chemistry

Device Facts

Record ID	K230648
Device Name	Access hsTnI
Applicant	Beckman Coulter, Inc.
Product Code	MMI · Clinical Chemistry
Decision Date	Dec 4, 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 Access 2 Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).

Device Story

Access hsTnI is a two-site immunoenzymatic 'sandwich' assay performed on the Access 2 Immunoassay System. Input: human serum or plasma sample. Process: sample mixed with monoclonal anti-cTnl antibody conjugated to alkaline phosphatase and surfactant-containing buffer; paramagnetic particles coated with monoclonal anti-cTnl antibody added; cTnl binds to solid phase; unbound materials washed away via magnetic field; chemiluminescent substrate added; light production measured by luminometer. Output: light signal proportional to analyte concentration, automatically calculated via stored calibration. Used in clinical laboratories by trained personnel. Software upgrade modifies washing efficiency (3 probe washes and 1 NaOH exposure) and reaction vessel mixing cycles to improve performance. Results aid clinicians in diagnosing myocardial infarction.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A3 (n=80 replicates per platform). Linearity and detection limits (LoB, LoD, LoQ) evaluated per CLSI EP06-A2 and EP17-A2. Method comparison (n=182 samples total) using Passing-Bablok regression showed high correlation (R=0.997-0.998) with the predicate. Thermal sensitivity studies confirmed performance stability across 18°C-28°C. No new clinical studies were required as the modification did not impact clinical performance claims or cut-offs established in K172787.

Technological Characteristics

Paramagnetic particle, chemiluminescent sandwich immunoassay. Materials: mouse monoclonal anti-human cTnl antibody, sheep monoclonal anti-human cTnl detection antibody. System: automated immunoassay instrument (Access 2). Connectivity: standalone. Software: updated Assay Protocol File (APF) for wash/mix cycles. Standards: CLSI EP05-A3, EP06, EP17-A2, EP09c.

Indications for Use

Indicated for the quantitative determination of cardiac troponin I (cTnl) levels 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 hsTnI (K172787)

Related Devices

K242870 — Access hsTnI · Beckman Coulter, Inc. · Jun 16, 2025
K243483 — Access hsTnI · Beckman Coulter, Inc. · Aug 1, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration." December 4, 2023 Stephanie Garth Principal of Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318 Re: K230648 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: October 31, 2023 Received: October 31, 2023 Dear Stephanie Garth: 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/cdrb/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). {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230648 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 Access 2 Immunoassay Systems 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) | #### 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." {3}------------------------------------------------ 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 eye or a wave pattern. To the right of the circle, the words "BECKMAN" and "COULTER" are written in bold, black letters, stacked vertically. The font is sans-serif and the overall design is clean and modern. ## 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. The assigned 510(k) number is K230648 #### Submitter Name and Address: Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 #### Contact Person: Stephanie Garth, Principal of Regulatory Affairs Phone: (469) 858 -1408 Email: sgarth01@beckman.com #### Alternate Contact: Kuljeet Kaur, RA, Senior Manager Phone: (952) 465 -1914 Email: kkaur@beckman.com #### Date Prepared: March 8, 2023 #### Device Name: Proprietary / Trade Name: Access hsTnl Common Name: Troponin I Enzyme Immunoassay Classification Name: Immunoassay, Troponin Subunits Classification Regulation: 21 CFR 862.1215 Classification Product Code: MMI #### Predicate Devices: Beckman Coulter, Inc. believes that the Access hsTnl run on the legacy Access 2 Immunoassay System (K172787 - Predicate) is substantially equivalent to the improved Access hsTnl with a software upgrade to assist with washing efficiency. The following table provides a comparison of the technological characteristics of the predicate Access hsTnl on the Access 2 with and without the modifications. {4}------------------------------------------------ ### Device Description: The Access hsTnI is a two-site immunoenzymatic ("sandwich") assay. Monoclonal anti-cTnl antibody coniugated to alkaline phosphatase is added to a reaction vessel along with a surfactant-containing buffer and sample. After a short incubation, paramagnetic particles coated with monoclonal anti-cTnl antibody are added. The human cTnl binds to the anti-cTnl antibody on the solid phase, while the anti-cTnl antibody-alkaline phosphatase conjugate reacts with different antigenic sites on the cTnl molecules. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration. #### 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 Access 2 Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI). | Characteristic | Access hsTnl K172787 - Predicate | Access hsTnI Candidate | |-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Intended Use/ Indications for 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 Access 2 Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI). | Same | | Assay Principle | Chemiluminescent | Same | | Technology | Sandwich | Same | | Test Systems | Automated immunoassay instrument | Same | | Sample Type | Serum and lithium heparin plasma | Same | | Sample Volume | 55µl | 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 | | Analytical Measuring Range | 2.0 pg/mL to 27,027 pg/mL | Same | | Characteristic | Access hsTnl K172787 - Predicate | Access hsTnl Candidate | | 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 lithium heparin plasma and 18.2 pg/mL with a 95% Confidence Interval (CI) of 13.1-23.1 pg/mL for serum. | 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 | | Access 2 Assay Protocol File (APF) | Access hsTnl APF with no thermal algorithm | Same | | General Device Characteristic Differences | | | | System software | In current system software architecture, RV mix could only happen at the end of the 4th cycle | Proposed system software architecture, RV mix can be utilized in any of the cycles | | Assay Protocol File (APF) | Access 2 1 probe wash after probes' final contact with reaction solutions and RV mix | Access 2 3 probe washes and 1 NAOH exposure after reagent probe's final contact with reaction solutions and RV mix | | Dilution factor/recovery Extended recovery range | Dilution Factor of 10 | 1:5 dilution factor and new limitation statement related to carryover | ## Substantial Equivalence Comparison: {5}------------------------------------------------ {6}------------------------------------------------ ## 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 Method comparison: Ninety two (92) samples (41 Lithium Heparin Plasma and 51 Serum) were analyzed across 2 Access 2 instruments, Each sample was measured using the IVD Access hsTnl (Current Assay Protocol File (APF)) as well as the proposed Access hsTnl (Proposed APF). The first replicate result from each sample was utilized to fit a Passing-Bablok linear regression model. 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 Access 2 for both lithium heparin plasma and serum samples. The bias data support the reference intervals defined on the instruments have not changed appreciably from the commercialized product. lmprecision: For Access 2 instrument the within-laboratory (total) % CV ranged from 3% to 4%, for Access hsTnl concentrations ≥ 11.5 pg/mL. The withinlaboratory (total) SD was 0.52 pq/mL for Access hsTnl concentration < 11.5 pg/mL. Linearity: This study shows that the analysis of the data finds that across both platforms, and for each sample concentration range, the higher order (2nd or 3rd) term of the polynomial fit is non-significant (p > 0.05), and if significant, the fit of the polynomial regression demonstrating significance have ≤ 10% bias across the analytical measuring range. LoB/LoD: The data demonstrated the LoB estimate of the Access hsTnl is 0.6 and the LoD estimate is 1.0 (serum) and 0.6 (plasma). LoQ: The LoQ for Access hsTnl at ≤20% with-in lab CV was determined to be 0.8 pg/mL (serum) and 0.7 (plasma). Carryover and new dilution factors: Access 2 demonstrated ≥ 95% of maximum individual replicate carryover events < 3.5 pg/mL when testing a low sample (≤ 10 pg/mL) following a high sample (~150,000 pg/mL). ## Substantial Equivalence Comparison Conclusion Beckman Coulter's Access hsTnl on the Access 2 Immunoassay System is substantially equivalent to Access hsTnl on the predicate 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.