(452 days)
Not Found
No
The summary describes a standard immunoassay for measuring cardiac troponin I levels and does not mention any AI or ML components in the device description or performance studies.
No
The device is an in vitro diagnostic (IVD) immunoassay designed for the quantitative determination of cardiac troponin I levels, specifically to aid in the diagnosis of myocardial infarction. It does not actively treat or ameliorate a disease, but rather provides diagnostic information.
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 explicitly states it consists of a reagent pack and calibrators, which are physical components, and is used with an immunoassay analyzer, which is also hardware.
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... 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) to provide diagnostic information.
- Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay" and mentions using "human serum and plasma." Immunoassays performed on bodily fluids are a common type of in vitro diagnostic test.
- Care Setting: The intended user is in a "clinical laboratory setting," which is where IVD tests are typically performed.
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 DxI Access Immunoassay Analyzers to aid in the diagnosis of myocardial infarction (MI).
Product codes
MMI
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.
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
clinical laboratory setting
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)
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
§ 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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION" in a smaller font.
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 (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) 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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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: (612) 431-7315 Email: kmoelberg@beckman.com
Alternate Contact:
Stephanie Garth Office Phone: (469) 858-1408 Email: SGARTH01@beckman.com
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 |