(270 days)
Not Found
No
The device description details a standard immunoassay technology and the performance studies focus on analytical performance metrics like precision, linearity, and limits of detection, which are typical for laboratory diagnostic tests and do not indicate the use of AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
This device is an in vitro diagnostic (IVD) immunoassay designed to quantitatively determine cardiac troponin I levels to aid in the diagnosis of myocardial infarction. It provides diagnostic information but does not actively treat or prevent disease.
Yes
The "Intended Use / Indications for Use" states that the device is used "to aid in the diagnosis of myocardial infarction (MI)".
No
The device description clearly outlines a paramagnetic particle, chemiluminescent immunoassay that uses physical components like reaction vessels, paramagnetic particles, and a luminometer. This is a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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)." This clearly indicates it's used to test samples taken from the human body in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay," which is a common type of laboratory test performed on biological samples.
- Sample Type: The device is designed to analyze "human serum and plasma," which are biological fluids.
These points strongly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
MMI
Device Description
The Access hsTnI is a two-site immunoenzymatic ("sandwich") assay. Monoclonal anti-cTnl 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-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.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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
§ 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.
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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
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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) |
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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 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 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