(266 days)
Not Found
No.
The document describes a chemical immunoassay system for measuring cardiac troponin I levels. It details the chemical reactions and measurement principles. There is no mention of AI, machine learning, or deep learning, nor any indication of image processing or complex algorithmic decision-making that would suggest the presence of an AI model. The "analyte concentration is automatically determined from a stored calibration," which implies a rule-based or look-up table method, not an AI model.
No
This device is an immunoassay kit used for diagnosing myocardial infarction by quantitatively determining cardiac troponin I levels; it aids in diagnosis, but does not directly treat or prevent a disease.
Yes
The device is an immunoassay designed for the quantitative determination of cardiac troponin I levels in human serum and plasma, specifically to "aid in the diagnosis of myocardial infarction (MI)." This directly aligns with the definition of a diagnostic device as it provides information for disease diagnosis.
No
The device is a laboratory immunoassay for measuring cardiac troponin I levels. It involves physical reagents, an immunoassay analyzer (Access 2 Immunoassay Analyzers), and luminometer measurements. This clearly indicates a hardware-dependent chemical and optical process, not a software-only device.
Yes.
The device is described as an immunoassay for the quantitative determination of cardiac troponin I levels in human serum and plasma to aid in the diagnosis of myocardial infarction, which involves testing samples derived from the human body for diagnostic purposes.
N/A
Intended Use / Indications for Use
Access hsTnI 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 Analyzers to aid in the diagnosis of myocardial infarction (MI).
Product codes
MMI
Device Description
The Access hsTnI assay is a two–site immunoenzymatic ("sandwich") assay. Monoclonal anti–cTnI antibody conjugated 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–cTnI antibody are added. The human cTnI binds to the anti–cTnI antibody on the solid phase, while the anti–cTnI antibody–alkaline phosphatase conjugate reacts with different antigenic sites on the cTnI 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Platform Equivalency by Sample Type:
- Study Design: Evaluated performance of multiple Access 2-DxC 500i instrument pairs using unique donor samples for each sample type (serum and lithium heparin plasma) independently.
- Sample Size: 106 for Serum, 122 for Plasma
- Measuring Range: 2.0 – 27,027 pg/mL
- Key Results:
- Serum:
- Concentration Range: 2.06 – 22,781 pg/mL
- Slope: 1.001 (95% CI: 0.976 – 1.020)
- Intercept: -0.184 pg/mL
- Correlation Coefficient (r): 0.999
- Plasma:
- Concentration Range: 2.25 – 26,379 pg/mL
- Slope: 0.997 (95% CI: 0.978 – 1.016)
- Intercept: 0.560 pg/mL
- Correlation Coefficient (r): 0.999
- Serum:
- Acceptance Criteria: Slope 1.00 ± 0.10.
Clinical performance (Method comparison studies):
- Study Design: Performed at two external test sites and one internal test site using three DxC 500i Clinical Analyzers and two Access 2 instruments. Samples evaluated over a minimum of three days in single replicates. Utilized three reagent lots and one calibrator lot.
- Sample Size: More than 200 discrete lithium heparin plasma samples at each site.
- Key Results: Met acceptance criteria of slope 1.00 ± 0.10 and r ≥ 0.90.
Imprecision:
- Study Type: CLSI EP05-A3 study
- Key Results:
- For troponin levels
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
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.(b)
Classification. Class II.
FDA 510(k) Clearance Letter - Access hsTnI
Page 1
June 16, 2025
Beckman Coulter, Inc.
Mary Beth Tang
Senior Staff Regulatory Affairs
250 South Kraemer Boulevard
Brea, California 92870
Re: K242870
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: May 9, 2025
Received: May 9, 2025
Dear Mary Beth Tang:
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.
Page 2
K242870 - Mary Beth Tang Page 2
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).
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-
Page 3
K242870 - Mary Beth Tang Page 3
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).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D.
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
Page 4
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): K242870
Device Name: Access hsTnI
Indications for Use (Describe):
Access hsTnI 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 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)
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:
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Page 5
510(k) Summary
Page 1 of 4
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 K242870.
Submitted By:
Beckman Coulter, Inc.
250 S. Kraemer Boulevard
Brea, CA 92821
Contact Person:
Mary Beth Tang
Senior Staff Regulatory Affairs
Telephone: 714-961-3728
Email: mbtang@beckman.com
Date of Preparation:
June 16, 2025
Device Name(s):
Proprietary Name: Access hsTnI
Common Name: Troponin I Enzyme Immunoassay
Classification Name: Immunoassay Method, Troponin Subunit
Class: Class II
Regulation Number: 21 CFR 862.1215
Product Code: MMI
Predicate Device:
| Candidate | Predicate | Manufacturer | Predicate Docket |
|---|---|---|---|
| Access hsTnI | Access hsTnI | Beckman Coulter, Inc. | K230648 |
Device Description:
The Access hsTnI assay is a two–site immunoenzymatic ("sandwich") assay. Monoclonal anti–cTnI antibody conjugated 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–cTnI antibody are added. The human cTnI binds to the anti–cTnI antibody on the solid phase, while the anti–cTnI antibody–alkaline phosphatase conjugate reacts with different antigenic sites on the cTnI 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
Page 6
510(k) Summary
Page 2 of 4
production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Intended Use:
Access hsTnI 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).
Substantial Equivalence Comparison:
| Characteristic | Access hsTnI Predicate (K230648) | Access hsTnI Candidate |
|---|---|---|
| Intended Use/ Indications for Use | Access hsTnI 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). | Same |
| Assay Principle | Chemiluminescent | Same |
| Technology | Sandwich | Same |
| Test Systems | Automated immunoassay instrument | Same |
| Sample Type | Serum and lithium heparin plasma | Same |
| Measuring Range | 2.0 pg/mL to 27,027 pg/mL | Same |
| Extended Range | 1:5 dilution factor and limitation statement related to carryover | Same |
| Precision | Within-laboratory SD ≤1.15 pg/mL for levels 150,000 pg/mL (ng/L) was tested on a DxC 500i system, intra-assay carryover was observed if an Access hsTnI was tested after a high cTnI sample. The extent of carryover observed was directly proportional to the cTnI concentration that was present in the high sample. In the studies, the estimated carryover was 3-5 pg/mL (ng/L) from a high sample at 270,000 pg/mL (ng/L) and 5-8 pg/mL (ng/L) from a high sample at 500,000 pg/mL (ng/L). For inter-assay carryover, which occurs when a high cTnI sample is tested on an assay other than hsTnI, performance, representative data for inter-assay carryover indicates the potential magnitude of carryover from samples at 27,000 pg/mL is expected to be |