(90 days)
No
The device is an in vitro diagnostic immunoassay that measures a biomarker. The analysis of the results involves statistical methods (hazard ratios, cumulative incidence) but does not describe the use of AI/ML algorithms for interpretation or prediction.
No
The device is an in vitro diagnostic assay used to measure cardiac troponin I in human serum or plasma to aid in the diagnosis of acute myocardial infarction and in prognosis for mortality and major adverse cardiac events. It does not directly treat or alleviate a disease, but rather provides information for diagnosis and prognosis.
Yes
The Intended Use / Indications for Use section explicitly states that the assay is "for in vitro diagnostic use" and "can be used to aid in the diagnosis of acute myocardial infarction (AMI)" and "as an aid in prognosis for 30-, 182-, and 365-day all-cause mortality (ACM) and major adverse cardiac events (MACE)".
No
The device is an in vitro diagnostic assay that measures a biomarker in blood using a physical analyzer and reagents, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "The Atellica® IM High-Sensitivity Troponin I (TnIH) assay is for in vitro diagnostic use".
- Device Description: It describes an assay that measures a biomarker (cardiac troponin I) in human serum or plasma, which are biological samples taken from the body and tested outside of it.
- Input Imaging Modality: It states "Not Applicable (In vitro diagnostic assay)", further confirming its nature.
- Anatomical Site: It states "Not Applicable (In vitro diagnostic assay measuring a biomarker in blood)", reinforcing that it's not used directly on a specific anatomical site.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Atellica® IM High-Sensitivity Troponin I (TnIH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human serum or plasma (lithium heparin) using the Atellica® IM Analyzer. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).
The Atellica IM TnIH assay can be used as an aid in prognosis for 30-, 182-, and 365-day all-cause mortality (ACM) and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS). MACE consists of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization.
Product codes (comma separated list FDA assigned to the subject device)
MMI
Device Description
The Atellica® IM TnIH assay is a 3-site sandwich immunoassay using direct chemiluminescent technology. The Solid Phase reagent consists of magnetic particles conjugated with streptavidin with 2 bound biotinylated capture monoclonal antibodies, each recognizing a unique cTnl epitope.
The Lite Reagent comprises a conjugate with an architecture consisting of a proprietary acridinium ester and a recombinant anti-human cTnl sheep Fab covalently attached to bovine serum albumin (BSA) for chemiluminescent detection.
A direct relationship exists between the amount of cTnl present in the patient sample and the amount of relative light units (RLUs) detected by the system.
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
licensed healthcare professionals.
This assay is labeled For Professional Use.
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
A clinical performance study was performed to establish additional performance claims for the Atellica® IM TnIH assay. The objective of this study was to evaluate whether a baseline Atellica® IM TnlH result in patients presenting to the emergency department (ED) with signs and symptoms of acute coronary syndrome (ACS) can predict future mortality or adverse cardiac events. This prognostic risk analysis utilized the same emergency department cohort previously described in K171566.
Following enrollment in the study, a detailed symptom history was obtained for each subject. The following information was collected from each subject's medical chart: age, gender, race, ethnicity, body mass index (BMI), current cardiac risk factors, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation estimate glomerular filtrate rate (eGFR) Interval (mL/min/1.73m²), concurrent medications, dates of ED admission and discharge, status of ischemic conditions (historically and at ED presentation), and status of acute myocardial infarction (AMI) at initial presentation. Current cardiac risk factors included hypertension, dyslipidemia, diabetes, tobacco use, and depressed left ventricular ejection fraction (LVEF). Ischemic conditions included myocardial infarction (MI), heart failure, and revascularization procedures (percutaneous coronary intervention or coronary artery bypass grafting surgery).
Patients presenting to the emergency department with signs and symptoms suggestive of ACS were followed up for 30-, 90-, 182-, and 365-day progression to ACM and MACE (consisting of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization). At each time point, the risk (cumulative incidence) and hazard ratios were calculated for populations with baseline cTnl levels ≤ or > the overall 99th percentile value. Kaplan-Meier curves were generated to display the absolute risk (cumulative incidence) of ACM and MACE outcomes. Analyses were performed for both serum and lithium heparin plasma sample types using the overall 99th percentile value.
Three populations were analyzed:
- Population 1: Entire Population Excluding Subjects with Adjudicated AMI (N=2064)
- Population 2: Entire Population Excluding Subjects with Adjudicated AMI as well as History of Incident or Prior MACE (N=1190 for lithium heparin plasma, N=1214 for serum)
- Population 3: Entire Population Excluding Subjects with Adjudicated AMI and Including those with History of Incident or Prior MACE (N=874)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical performance study was performed to establish additional performance claims for the Atellica® IM TnIH assay. The objective of this study was to evaluate whether a baseline Atellica® IM TnlH result in patients presenting to the emergency department (ED) with signs and symptoms of acute coronary syndrome (ACS) can predict future mortality or adverse cardiac events.
Key results:
The study generated pre- and post-test risk and unadjusted hazard ratios, multivariable Cox proportional hazards (PH) model parameters, and event types, as well as Kaplan-Meier curves, for three populations based on the overall 99th percentile value:
Population 3: Entire Population Excluding Subjects with Adjudicated AMI and Including those with History of Incident or Prior MACE (N=874)
- 30 Days: Unadjusted Hazard Ratio 1.61 (0.87, 2.98), Adjusted Hazard Ratio 1.07 (0.54, 2.09) (Not Statistically Significant)
- 90 Days: Unadjusted Hazard Ratio 2.24 (1.52, 3.29), Adjusted Hazard Ratio 1.61 (1.06, 2.45)
- 182 Days: Unadjusted Hazard Ratio 2.09 (1.51, 2.90), Adjusted Hazard Ratio 1.59 (1.12, 2.26)
- 365 Days: Unadjusted Hazard Ratio 2.21 (1.67, 2.92), Adjusted Hazard Ratio 1.56 (1.15, 2.12)
Population 2: Entire Population Excluding Subjects with Adjudicated AMI as well as History of Incident or Prior MACE
- Lithium Heparin Plasma (N=1190):
- 30 Days: Unadjusted Hazard Ratio 10.89 (2.72, 43.53), Adjusted Hazard Ratio 7.46 (1.65, 33.65)
- 90 Days: Unadjusted Hazard Ratio 6.84 (2.23, 20.98), Adjusted Hazard Ratio 5.58 (1.69, 18.47)
- 182 Days: Unadjusted Hazard Ratio 5.28 (2.32, 12.02), Adjusted Hazard Ratio 3.89 (1.63, 9.30)
- 365 Days: Unadjusted Hazard Ratio 3.69 (1.75, 7.79), Adjusted Hazard Ratio 2.79 (1.28, 6.08)
- Serum (N=1214):
- 30 Days: Unadjusted Hazard Ratio 5.08 (1.08, 23.94), Adjusted Hazard Ratio 2.84 (0.56, 14.38) (Not Statistically Significant)
- 90 Days: Unadjusted Hazard Ratio 3.87 (1.13, 13.28), Adjusted Hazard Ratio 2.81 (0.78, 10.12) (Not Statistically Significant)
- 182 Days: Unadjusted Hazard Ratio 3.80 (1.59, 9.07), Adjusted Hazard Ratio 2.71 (1.10, 6.69)
- 365 Days: Unadjusted Hazard Ratio 2.75 (1.25, 6.05), Adjusted Hazard Ratio 2.06 (0.92, 4.64) (Not Statistically Significant)
Population 1: Entire Population Excluding Subjects with Adjudicated AMI (N=2064)
- 30 Days: Unadjusted Hazard Ratio 3.21 (1.83, 5.64), Adjusted Hazard Ratio 1.55 (0.84, 2.89) (Not Statistically Significant)
- 90 Days: Unadjusted Hazard Ratio 4.03 (2.80, 5.80), Adjusted Hazard Ratio 2.03 (1.36, 3.01)
- 182 Days: Unadjusted Hazard Ratio 3.66 (2.71, 4.95), Adjusted Hazard Ratio 1.97 (1.42, 2.73)
- 365 Days: Unadjusted Hazard Ratio 3.64 (2.81, 4.72), Adjusted Hazard Ratio 1.85 (1.39, 2.47)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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 blue.
July 25, 2024
Siemens Healthcare Diagnostics Inc. Amy Tyler Regulatory Affairs Professional 500 GBC Drive, P.O. Box 6101 Mail Stop 514 Newark, Delaware 19714
Re: K241165
Trade/Device Name: Atellica® IM High-Sensitivity Troponin I (TnIH) Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine Phosphokinase/Creatine Kinase Or Isoenzymes Test System Regulatory Class: Class II Product Code: MMI Dated: April 22, 2024 Received: April 26, 2024
Dear Amy Tyler:
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).
1
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 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. 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) K241165
Device Name Atellica® IM High-Sensitivity Troponin I (TnIH)
Indications for Use (Describe)
The Atellica® IM High-Sensitivity Troponin I (TnIH) assay is for in the quantitative measurement of cardiac troponin I in human serum or plasma (lithium heparin) using the Atellica® IM Analyzer. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).
The Atellica IM TnIH assay can be used as an aid in prognosis for 30-, 182-, and 365-day all-cause mortality (ACM) and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS). MACE consists of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Act of 1990.
The assigned 510(k) number is: K241165
1. Date Prepared
July 25, 2024
2. Applicant Information
| Contact: | Amy Tyler
Regulatory Affairs Professional |
|----------|----------------------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc.
500 GBC Drive, P.O. Box 6101
Newark, DE 19714, USA |
| Phone: | 610-836-1390 |
| Email: | amy.c.tyler@siemens-healthineers.com |
3. Regulatory Information
| Trade Name | Atellica® IM High-Sensitivity Troponin I (TnIH) |
|---|---|
| Model Numbers | 10997840 (1-pack); 10997841 (5-pack) |
| Device Classification Name | Immunoassay Method, Troponin Subunit |
| Regulation Number | 21 CFR 862.1215 |
| Regulation Description | Creatine phosphokinase/creatine kinase or isoenzymes test system |
| Product Code | MMI |
| FDA Classification | Class II |
| Review Panel | Clinical Chemistry |
4. Predicate Device Information
Device Name: VITROS Troponin I ES Assay
510(k) Number: K062838
5. Intended Use / Indications for Use
The Atellica® IM High-Sensitivity Troponin I (TnlH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human serum or plasma (lithium heparin) using the Atellica® IM Analyzer. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).
4
The Atellica IM TnIH assay can be used as an aid in prognosis for 30-, 182-, and 365-day all-cause mortality (ACM) and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS). MACE consists of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization.
6. Device Description
The Atellica® IM TnIH assay is a 3-site sandwich immunoassay using direct chemiluminescent technology. The Solid Phase reagent consists of magnetic particles conjugated with streptavidin with 2 bound biotinylated capture monoclonal antibodies, each recognizing a unique cTnl epitope.
The Lite Reagent comprises a conjugate with an architecture consisting of a proprietary acridinium ester and a recombinant anti-human cTnl sheep Fab covalently attached to bovine serum albumin (BSA) for chemiluminescent detection.
A direct relationship exists between the amount of cTnl present in the patient sample and the amount of relative light units (RLUs) detected by the system.
| Component | Volume | Ingredients |
|---|---|---|
| Atellica® IM TnIH ReadyPack® primary reagent pack (included in assay kit) | ||
| Lite Reagent | 8.0 mL/reagent pack | Bovine serum albumin (BSA) conjugated to a |
| recombinant monoclonal (sheep) Fab anti- | ||
| human cTnl (~0.2-0.4 µg/mL) labeled with | ||
| acridinium ester in HEPES buffer; stabilizers; | ||
| preservatives | ||
| Solid Phase | 13.0 mL/reagent | |
| pack | Streptavidin-coated magnetic particles (0.45 | |
| mg/mL) with 2 biotinylated (mouse and | ||
| sheep) monoclonal anti-troponin I | ||
| antibodies in buffer; stabilizers; | ||
| preservatives | ||
| Atellica® IM TnIH Calibrator (included in assay kit) | ||
| Atellica® IM TnIH CAL L | 1.0 mL/vial | HEPES buffer; bovine serum albumin (BSA); |
| surfactants; preservatives | ||
| Atellica® IM TnIH CAL H | 1.0 mL/vial | |
| (lyophilized) | After reconstitution, human serum; human | |
| cTnl; preservatives | ||
| Atellica® IM TnIH Master Curve Material (sold separately)* | ||
| Atellica® IM TnIH MCM | ||
| (master curve material) | 1.0 mL/vial | |
| (lyophilized) | Human troponin I complex in a human | |
| serum base, with preservatives |
The Atellica® IM TnIH assay consists of the components described in the following table.
*Additional information for this product is not included in this 510(k) because as of 2017-04-13, this device (Product Code JJX; Regulation No. 862.1660; Single (Specified) Analyte Controls (Assayed and Unassayed)) is exempt from pre-market notification requirements, as described in FDA Notice Docket No. FDA-2017-N-1610.
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7. Purpose of the Submission
The purpose of this 510(k) premarket notification is to add an indication for use so that the assay can be used as an aid in prognosis for 30-, 90-, 182-, and 365-day all-cause mortality (ACM) and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS). MACE consists of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization.
8. Comparison of Candidate Device and Predicate Devices
The following table describes the similarities and differences between the Atellica® IM High-Sensitivity Troponin I (TnlH) assay (Candidate Device) and the VITROS Troponin I ES Assay (Predicate Device).
6
| Candidate Device | Predicate Device | |
|---|---|---|
| Attributes | Atellica® IM High-Sensitivity Troponin I (TnIH) | VITROS Troponin I ES Assay - K062838 |
| Intended Use | The Atellica® IM High-Sensitivity Troponin I | |
| (TnIH) assay is for in vitro diagnostic use in | ||
| the quantitative measurement of cardiac | ||
| troponin I in human serum or plasma (lithium | ||
| heparin) using the Atellica® IM Analyzer. The | ||
| assay can be used to aid in the diagnosis of | ||
| acute myocardial infarction (AMI). |
The Atellica® IM TnIH assay can be used as an
aid in prognosis for 30-, 90-, 182-, and 365-
day all-cause mortality (ACM) and major
adverse cardiac events (MACE) in patients
presenting with signs and symptoms
suggestive of acute coronary syndrome (ACS).
MACE consists of myocardial infarction,
urgent revascularization, cardiac death, or
heart failure hospitalization. | For the quantitative measurement of cardiac
Troponin I (cTnl) in human serum and plasma
(heparin and EDTA) using the VITROS
ECi/ECiQ Immunodiagnostic Systems, the
VITROS 3600 Immunodiagnostic System and
the VITROS 5600 Integrated System, to aid in
the assessment of myocardial damage and
risk stratification.
Cardiac Troponin I measurement aids in the
diagnosis of acute myocardial infarction and
in the risk stratification of patients with non-
ST-segment elevation acute coronary
syndromes with respect to relative risk of
mortality, myocardial infarction (MI) or
increased probability of ischemic events
requiring urgent revascularization
procedures. |
| Indications for Use | The assay can be used to aid in the
diagnosis of acute myocardial infarction
(AMI). The assay can be used as an aid in
prognosis for all-cause mortality (ACM)
and major adverse cardiac events (MACE)
in patients presenting with signs and
symptoms suggestive of acute coronary
syndrome (ACS). | The assay can be used to aid in the
diagnosis of acute myocardial infarction
(AMI). The assay can be used as an aid in risk
stratification of patients with non-ST
segment elevation acute coronary
syndromes with respect to relative risk of
mortality, MI, or increased probability of
ischemic events. The assay can be used to aid in the
assessment of myocardial damage. |
| Methodology | Chemiluminescence | Chemiluminescence |
| Assay protocol | Sandwich immunoassay | Sandwich immunoassay |
| Analyte | Cardiac troponin I | Cardiac troponin I |
| Specimen Type | Serum, lithium-heparin plasma | Serum and plasma (heparin and EDTA) |
| Lower Limit of | LoQ | LoQ |
| Measuring Range | (2.50 pg/mL) | (0.012 ng/mL (12 pg/mL)) |
| Measuring Range | 2.50-25,000.00 pg/mL (ng/L) | 0.012 - 80.0 ng/mL (12-80,000 pg/mL) |
| Upper 99th
Percentile Cutoff | Female-Lithium Heparin: 34.11 pg/mL
Male-Lithium Heparin: 53.48 pg/mL
Combined-Lithium Heparin: 45.20 pg/mL
Female-Serum: 38.64 pg/mL
Male-Serum: 53.53 pg/mL
Combined-Serum: 45.43 pg/mL
Overall: 45.20 pg/mL | 0.034 ng/mL
(34 pg/mL) |
| Calibration | 2-point calibration | 3 levels |
Comparison Table of Candidate Device and Predicate Device
7
The VITROS Troponin I ES Assay was selected as the predicate device for the risk stratification indication for use. The comparison table examines similarities and differences between the candidate and predicate devices for this indication for use. The predicate device was selected based on the following information:
- The predicate device is legally marketed (cleared under K062838).
- The intended use includes the use of Cardiac Troponin I measurements to aid in the diagnosis of acute myocardial infarction, as well as an indication for use for risk stratification.
- Both assays are sandwich assays using chemiluminescent technology indicating that they share the same technological characteristics.
- While the predicate device has a wider measuring range, the measuring range for the candidate device is clinically acceptable since critical concentrations for cardiac troponin I (99th percentile values) are at the lower end of the measuring range. Both assays measure concentrations at low levels suitable for cardiac troponin I. As a result, this difference does not raise questions related to safety or effectiveness.
- The candidate device is more sensitive based on the lower limit of the measuring interval as determined by the Limit of Quantitation.
- . Although the predicate device was considered a high-sensitivity assay based on the definition available at the time of clearance, the candidate device meets the current definition of a highsensitivity assay which includes an additional requirement for at least 50% of measurements from healthy individuals used to determine the 99th percentile value to be above the LoD for the device.
Based on this comparison, the performance characteristics of the candidate device are substantially equivalent to the predicate device to support the addition of an indication for use as an aid in prognosis for all-cause mortality (ACM) and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS).
The candidate device is substantially equivalent in principle and performance to the predicate device cleared under K062838, based on the intended use for diagnosis of AMI, as well as a prognosis indication for use, and performance characteristics.
All analytical performance claims for the candidate device remain the same as the device that was previously cleared in K171566. No changes have been made to the physical device. The purpose of this submission is to expand the intended use of the device to include an indication for use to aid in prognosis for all-cause mortality (ACM) and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS).
9. Special Instrument Requirement
The Atellica® IM TnIH assay is for in vitro diagnostic use with the Atellica® IM Analyzer.
The Atellica® IM Analyzer was previously cleared under 510(k) K151792. Please note that the product name associated with this submission is the interim project name of "Trinidad IM System". The instrument was subsequently assigned the trade name of "Atellica® IM Analyzer".
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10. Special Conditions for Use Statements
The assay is intended to be used by licensed healthcare professionals.
This assay is labeled For Professional Use.
11. Performance Characteristics – Clinical Study
A clinical performance study was performed to establish additional performance claims for the Atellica® IM TnIH assay.
The objective of this study was to evaluate whether a baseline Atellica® IM TnlH result in patients presenting to the emergency department (ED) with signs and symptoms of acute coronary syndrome (ACS) can predict future mortality or adverse cardiac events.
This prognostic risk analysis utilized the same emergency department cohort previously described in K171566. Following enrollment in the study, a detailed symptom history was obtained for each subject. The following information was collected from each subject's medical chart: age, gender, race, ethnicity, body mass index (BMI), current cardiac risk factors, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation estimate glomerular filtrate rate (eGFR) Interval (mL/min/1.73m²), concurrent medications, dates of ED admission and discharge, status of ischemic conditions (historically and at ED presentation), and status of acute myocardial infarction (AMI) at initial presentation. Current cardiac risk factors included hypertension, dyslipidemia, diabetes, tobacco use, and depressed left ventricular ejection fraction (LVEF). Ischemic conditions included myocardial infarction (MI), heart failure, and revascularization procedures (percutaneous coronary intervention or coronary artery bypass grafting surgery).
Patients presenting to the emergency department with signs and symptoms suggestive of ACS were followed up for 30-, 90-, 182-, and 365-day progression to ACM and MACE (consisting of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization). At each time point, the risk (cumulative incidence) and hazard ratios were calculated for populations with baseline cTnl levels ≤ or > the overall 99th percentile value. Kaplan-Meier curves were generated to display the absolute risk (cumulative incidence) of ACM and MACE outcomes. Analyses were performed for both serum and lithium heparin plasma sample types using the overall 99th percentile value. The following tables present pre- and post-test risk and unadjusted hazard ratios, multivariable Cox proportional hazards (PH) model parameters, and event types, as well as Kaplan-Meier curves, for the following populations based on the overall 99th percentile value:
- Population 1: Entire Population Excluding Subjects with Adjudicated AMI
- Population 2: Entire Population Excluding Subjects with Adjudicated AMI as well as History of Incident or Prior MACE
- Population 3: Entire Population Excluding Subjects with Adjudicated AMI and Including those with History of Incident or Prior MACE
For Populations 1 and 3, results are shown for lithium heparin plasma samples. Similar results were observed for serum samples. For population 2, results are shown for lithium heparin plasma and serum samples. Confidence intervals were generated in accordance with CLSI EP12-Ed3.
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Population 3: Entire Population Excluding Subjects with Adjuding those with History of Incident or Prior MACE
| Follow-Up
Time Points | Prevalence of ACM/MACE | | | Risk of ACM/MACE for patients with cTnl levels
99th Percentile | | | Risk of ACM/MACE for patients with cTnl levels
99th Percentile, N=137
(%) |
|--------------------------------------|---------------------|--------------------------------|--------------------------------|
| Survived to day 365 with no ACM/MACE | 606 | 537 | 69 |
| Censor (Loss to follow-up) | 9 | 8 | 1 |
| ACM/MACE | 259 | 192 | 67 |
| Breakdown of ACM/MACE outcomes | | | |
| Cardiac Death | 10 (3.86) | 9 (4.69) | 1 (1.49) |
| HF Hospitalization | 163 (62.93) | 113 (58.85) | 50 (74.63) |
| Incident Death | 8 (3.09) | 5 (2.60) | 3 (4.48) |
| MI | 17 (6.56) | 13 (6.77) | 4 (5.97) |
| MI, HF Hospitalization | 2 (0.77) | 1 (0.52) | 1 (1.49) |
| MI, Urgent Revas | 7 (2.70) | 7 (3.65) | 0 (0.00) |
| MI, Urgent Revas, HF Hospitalization | 1 (0.39) | 1 (0.52) | 0 (0.00) |
| Other Death | 26 (10.04) | 19 (9.90) | 7 (10.45) |
| Urgent Revas | 24 (9.27) | 23 (11.98) | 1 (1.49) |
| Urgent Revas, HF Hospitalization | 1 (0.39) | 1 (0.52) | 0 (0.00) |
11
Image /page/11/Figure/1 description: The image shows the title of a graph. The title is "Kaplan-Meier Curves for Population 3". The title is written in a clear, sans-serif font and is centered on the image.
Image /page/11/Figure/2 description: The image is a graph that shows the absolute risk of ACM/MACE (%) over time. The x-axis represents the follow-up time in days, ranging from 0 to 365. The y-axis represents the absolute risk of ACM/MACE (%) and ranges from 0 to 60. There are two lines on the graph, one representing less than or equal to the 99th percentile and the other representing greater than the 99th percentile, along with a 95% confidence interval.
| Number at Risk | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Follow up Time (Days) | 0 | 30 | 60 | 90 | 120 | 150 | 182 | 210 | 240 | 270 | 300 | 330 | 365 |
| ≤ 99th percentile value | 737 | 690 | 668 | 641 | 625 | 614 | 590 | 582 | 576 | 566 | 559 | 548 | 365 |
| > 99th percentile value | 137 | 123 | 111 | 101 | 96 | 93 | 87 | 83 | 80 | 79 | 75 | 74 | 44 |
12
Population 2: Entire Population Excluding Subjects with Adjudicated AMI as well as History of Incident or Prior MACE
Pre- and Post-Test Risks and Unadjusted Hazard Ratios using the Overall 99th Percentile Value for Population 2
| Follow-Up
Time Points | Prevalence of ACM/MACE | | | | Risk of ACM/MACE for patients with cTnl levels
99th Percentile | | | Risk of ACM/MACE for patients with cTnl levels
≤99th Percentile | | | Unadjusted Hazard
Ratio
(95% CI)a |
|--------------------------|-----------------------------|---------------------------------|----------------------------------|--|--------------------------------------------------------------------|---------------------------------|-----------------------------------------------|--------------------------------------------------------------------|---------------------------------|----------------------------------------------|-----------------------------------------|
| | Total Number
of Patients | Number of
ACM/MACE
events | Pre-test risk of
ACM/MACE (%) | | Total Number
of Patients | Number of
ACM/MACE
events | Post-test risk of
ACM/MACE
(%, 95% CIb) | Total Number
of Patients | Number of
ACM/MACE
events | Post-test risk of
ACM/MACE
(%, 95% CI) | |
| Lithium Heparin Plasma | | | | | | | | | | | |
| 30 Days | 1190 | 9 | 0.8 | | 53 | 3 | 5.7
(2.2, 13.6) | 1137 | 6 | 0.5
(0.3, 0.8) | 10.89 (2.72, 43.53) |
| 90 Days | 1190 | 17 | 1.4 | | 53 | 4 | 7.5
(3.2, 16.7) | 1137 | 13 | 1.1
(0.9, 1.5) | 6.84 (2.23, 20.98) |
| 182 Days | 1190 | 37 | 3.1 | | 53 | 7 | 13.2
(6.9, 23.9) | 1137 | 30 | 2.6
(2.3, 3.1) | 5.28 (2.32, 12.02) |
| 365 Days | 1190 | 58 | 4.9 | | 53 | 8 | 15.1
(8.1, 26.4) | 1137 | 50 | 4.4
(4.0, 4.9) | 3.69 (1.75, 7.79) |
| Serum | | | | | | | | | | | |
| 30 Days | 1214 | 10 | 0.8 | | 57 | 2 | 3.5
(1.0, 11.4) | 1157 | 8 | 0.7
(0.5, 0.9) | 5.08 (1.08, 23.94) |
| 90 Days | 1214 | 19 | 1.6 | | 57 | 3 | 5.3
(1.9, 13.9) | 1157 | 16 | 1.4
(1.1, 1.7) | 3.87 (1.13, 13.28) |
| 182 Days | 1214 | 39 | 3.2 | | 57 | 6 | 10.5
(5.1, 20.5) | 1157 | 33 | 2.9
(2.5, 3.2) | 3.80 (1.59, 9.07) |
| 365 Days | 1214 | 61 | 5.0 | | 57 | 7 | 12.3
(6.2, 22.8) | 1157 | 54 | 4.7
(4.3, 5.1) | 2.75 (1.25, 6.05) |
ª Univariate Cox Proportional Hazards Regression Analysis.
b CI = Confidence Interval.
13
| Follow-Up Time Point | Na | Adjusted Hazard Ratio (95% CI) b,c |
|---|---|---|
| Lithium Heparin Plasma | ||
| 30 Days | 1169 | 7.46 (1.65, 33.65) |
| 90 Days | 1169 | 5.58 (1.69, 18.47) |
| 182 Days | 1169 | 3.89 (1.63, 9.30) |
| 365 Days | 1169 | 2.79 (1.28, 6.08) |
| Serum | ||
| 30 Days | 1192 | 2.84 (0.56, 14.38)d |
| 90 Days | 1192 | 2.81 (0.78, 10.12)d |
| 182 Days | 1192 | 2.71 (1.10, 6.69) |
| 365 Days | 1192 | 2.06 (0.92, 4.64)d |
Adjusted Hazard Ratios for Population 2
ª Number of patient samples tested.
ª Adjusted for estimated glomerular filtration rate (eGFR), hypertension, and gender. In this data set, smoking, diabetes, BMI, race, and age were also evaluated and were not significantly associated with cumulative ACM/MACE statistically. Prior MJ statins, and LVEF were evaluated and removed from the model due to observed multicollinearity.
Cox proportional hazards multivariable regression analysis.
d Not Statistically Significant (based on 95% CI)
Summary of Multivariable Cox PH Model Parameters for Population 2
| Adjusted hazard ratios (95% CI) | ||||
|---|---|---|---|---|
| Follow-Up Time Point | cTnl | eGFR | Hypertension | Gender |
| Lithium Heparin Plasma | ||||
| 30 days | 7.46 (1.65, 33.65) | 2.16 (0.46, 10.08)b | 2.07 (0.41, 10.54)b | 1.32 (0.35, 4.94)b |
| 90 days | 5.58 (1.69, 18.47) | 1.73 (0.51, 5.92)b | 1.21 (0.43, 3.41)b | 1.52 (0.58, 4.02)b |
| 182 days | 3.89 (1.63, 9.30) | 2.41 (1.09, 5.33) | 1.18 (0.58, 2.40)b | 1.56 (0.81, 3.00)b |
| 365 days | 2.79 (1.28, 6.08) | 2.30 (1.21, 4.40) | 1.20 (0.69, 2.09)b | 1.53 (0.90, 2.58)b |
| Serum | ||||
| 30 days | 2.84 (0.56, 14.38)b | 4.05 (1.05, 15.68) | 2.28 (0.46, 11.30)b | 1.52 (0.43, 5.40)b |
| 90 days | 2.81 (0.78, 10.12)b | 2.49 (0.84, 7.38)b | 1.41 (0.52, 3.85)b | 1.43 (0.57, 3.57)b |
| 182 days | 2.71 (1.10, 6.69) | 2.89 (1.37, 6.08) | 1.26 (0.63, 2.53)b | 1.49 (0.78, 2.82)b |
| 365 days | 2.06 (0.92, 4.64)b | 2.61 (1.41, 4.84) | 1.19 (0.69, 2.05)b | 1.52 (0.91, 2.53)b |
³ CI = Confidence Interval
b Not Statistically Significant (based on 95% CI)
14
Event Types Summary using the Overall 99th Percentile Value for Population 2 Lithium Heparin Plasma
| Type of Event | Total, N=1190
(%) | ≤99th Percentile, N=1137
(%) | >99th Percentile, N=53
(%) |
|--------------------------------------|----------------------|---------------------------------|-------------------------------|
| Survived to day 365 with no ACM/MACE | 1118 | 1073 | 45 |
| Censor (Loss to follow-up) | 14 | 14 | 0 |
| ACM/MACE | 58 | 50 | 8 |
| Breakdown of ACM/MACE outcomes | | | |
| Cardiac Death | 2 (3.45) | 2 (4.00) | 0 (0.00) |
| HF Hospitalization | 29 (50.00) | 23 (46.00) | 6 (75.00) |
| MI | 4 (6.90) | 3 (6.00) | 1 (12.50) |
| MI, Urgent Revas, Cardiac Death | 1 (1.72) | 0 (0.00) | 1 (12.50) |
| Other Death | 14 (24.14) | 14 (28.00) | 0 (0.00) |
| Urgent Revas | 8 (13.79) | 8 (16.00) | 0 (0.00) |
Serum
| Type of Event | Total, N=1214 | ≤99th Percentile,
N=1157 | >99th Percentile, N=57 |
|--------------------------------------|---------------|-----------------------------|------------------------|
| Survived to day 365 with no ACM/MACE | 1139 | 1089 | 50 |
| Censor (Loss to follow-up) | 14 | 14 | 0 |
| ACM/MACE | 61 | 54 | 7 |
| Breakdown of ACM/MACE event | | | |
| Cardiac Death | 2 (3.28) | 2 (3.70) | 0 (0.00) |
| HF Hospitalization | 31 (50.82) | 26 (48.15) | 5 (71.43) |
| MI | 4 (6.56) | 3 (5.56) | 1 (14.29) |
| MI, Urgent Revas, Cardiac Death | 1 (1.64) | 0 (0.00) | 1 (14.29) |
| Other Death | 14 (22.95) | 14 (25.93) | 0 (0.00) |
| Urgent Revas | 9 (14.75) | 9 (16.67) | 0 (0.00) |
15
Kaplan-Meier Curves for Population 2 Lithium Heparin Plasma
Image /page/15/Figure/2 description: The figure is a graph that shows the absolute risk of ACM/MACE (%) over a follow-up time in days. The x-axis represents the follow-up time in days, ranging from 0 to 365. The y-axis represents the absolute risk of ACM/MACE (%), ranging from 0 to 60. There are two lines on the graph, one representing less than or equal to the 99th percentile and the other representing greater than the 99th percentile. The graph shows that the absolute risk of ACM/MACE is higher for those greater than the 99th percentile.
| Number at Risk | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Follow up Time (Days) | 0 | 30 | 60 | 90 | 120 | 150 | 182 | 210 | 240 | 270 | 300 | 330 | 365 |
| ≤ 99th percentile value | 1137 | 1128 | 1120 | 1113 | 1107 | 1103 | 1095 | 1090 | 1084 | 1081 | 1079 | 1078 | 742 |
| > 99th percentile value | 53 | 50 | 49 | 49 | 49 | 47 | 46 | 46 | 46 | 46 | 45 | 45 | 30 |
16
Image /page/16/Figure/1 description: The figure shows the absolute risk of ACM/MACE (%) over time. The x-axis represents the follow-up time in days, ranging from 0 to 365. The y-axis represents the absolute risk of ACM/MACE (%), ranging from 0 to 60. There are two lines on the plot, one representing values less than or equal to the 99th percentile and the other representing values greater than the 99th percentile, along with their 95% confidence intervals.
| Number at Risk | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Follow up Time (Days) | 0 | 30 | 60 | 90 | 120 | 150 | 182 | 210 | 240 | 270 | 300 | 330 | 365 |
| ≤ 99th percentile value | 1157 | 1146 | 1137 | 1130 | 1124 | 1120 | 1112 | 1106 | 1100 | 1097 | 1095 | 1094 | 748 |
| > 99th percentile value | 57 | 55 | 54 | 54 | 54 | 52 | 51 | 51 | 51 | 51 | 50 | 50 | 33 |
17
| Follow-Up
Time Points | Prevalence of ACM/MACE | | | Risk of ACM/MACE for patients with cTnl levels
99th Percentile | | | Risk of ACM/MACE for patients with cTnl levels
≤99th Percentile | | | Unadjusted Hazard
Ratio
(95% CI)a |
|--------------------------|-----------------------------|---------------------------------|----------------------------------|--------------------------------------------------------------------|---------------------------------|-----------------------------------------------|--------------------------------------------------------------------|---------------------------------|----------------------------------------------|-----------------------------------------|
| | Total Number
of Patients | Number of
ACM/MACE
events | Pre-test risk of
ACM/MACE (%) | Total Number
of Patients | Number of
ACM/MACE
events | Post-test risk of
ACM/MACE
(%, 95% CIb) | Total Number
of Patients | Number of
ACM/MACE
events | Post-test risk of
ACM/MACE
(%, 95% CI) | |
| 30 Days | 2064 | 67 | 3.2 | 190 | 16 | 8.4
(5.5, 12.6) | 1874 | 51 | 2.7
(2.4, 3.1) | 3.21 (1.83, 5.64) |
| 90 Days | 2064 | 146 | 7.1 | 190 | 40 | 21.1
(16.4, 26.6) | 1874 | 106 | 5.7
(5.1, 6.2) | 4.03 (2.80, 5.80) |
| 182 Days | 2064 | 227 | 11.0 | 190 | 56 | 29.5
(24.0, 35.6) | 1874 | 171 | 9.1
(8.5, 9.8) | 3.66 (2.71, 4.95) |
| 365 Days | 2064 | 317 | 15.4 | 190 | 75 | 39.5
(33.3, 46.0) | 1874 | 242 | 12.9
(12.2, 13.6) | 3.64 (2.81, 4.72) |
| Pre- and Post-Test Risks and Unadjusted Hazard Ratios using the Overall 99th Percentile Value for Population 1 | |||
|---|---|---|---|
| ---------------------------------------------------------------------------------------------------------------- | -- | -- | -- |
³ Univariate Cox Proportional Hazards Regression Analysis.
ხ CI = Confidence Interval.
18
| Follow-Up Time Point | Na | Adjusted Hazard Ratio (95% CI) b,c |
|---|---|---|
| 30 Days | 1968 | 1.55 (0.84, 2.89)d |
| 90 Days | 1968 | 2.03 (1.36, 3.01) |
| 182 Days | 1968 | 1.97 (1.42, 2.73) |
| 365 Days | 1968 | 1.85 (1.39, 2.47) |
Adjusted Hazard Ratios for Population 1
ª Number of patient samples tested.
♪ Adjusted for prior revascularization, prior heart filtration rate (eGFR), hypertension, and gender. In this data set, smoking, diabetes, BMI, race, and age were also evaluated and were not significantly associated with cumulative ACM/MACE statistically. Prior MI, statins, and LVEF were evaluated and removed from the model due to observed multicollinearity.
° Cox proportional hazards multivariable regression analysis.
d Not Statistically Significant (based on 95% CI)
Summary of Multivariable Cox PH Model Parameters for Population 1
| Adjusted hazard ratios (95% CIa) | ||||||
|---|---|---|---|---|---|---|
| Follow-Up | ||||||
| Time Point | cTnl | Prior | ||||
| Revascularization | Prior Heart Failure | eGFR | Hypertension | Gender | ||
| 30 days | 1.55 (0.84, 2.89)b | 1.19 (0.71, 2.02)b | 3.62 (2.07, 6.33) | 1.74 (1.02, 2.98) | 1.87 (0.86, 4.05)b | 1.62 (0.94, 2.79)b |
| 90 days | 2.03 (1.36, 3.01) | 1.39 (0.98, 1.97)b | 4.35 (2.96, 6.38) | 1.60 (1.11, 2.29) | 1.93 (1.12, 3.31) | 1.48 (1.03, 2.14) |
| 182 days | 1.97 (1.42, 2.73) | 1.50 (1.13, 1.98) | 3.79 (2.80, 5.12) | 1.56 (1.16, 2.08) | 1.85 (1.23, 2.80) | 1.37 (1.03, 1.82) |
| 365 days | 1.85 (1.39, 2.47) | 1.47 (1.16, 1.88) | 3.80 (2.94, 4.92) | 1.63 (1.27, 2.10) | 1.75 (1.24, 2.45) | 1.37 (1.08, 1.74) |
³ CI = Confidence Interval
b Not Statistically Significant (based on 95% CI)
Event Types Summary using the Overall 99th Percentile Value for Population 1
| Type of Event | Total, N=2064
(%) | ≤99th percentile, N=1874
(%) | >99th percentile, N=190
(%) |
|--------------------------------------|----------------------|---------------------------------|--------------------------------|
| Survived to day 365 with no ACM/MACE | 1724 | 1610 | 114 |
| Censor (Loss to follow-up) | 23 | 22 | 1 |
| ACM/MACE | 317 | 242 | 75 |
| Breakdown of ACM/MACE outcomes | | | |
| Cardiac Death | 12 (3.79) | 11 (4.55) | 1 (1.33) |
| HF Hospitalization | 192 (60.57) | 136 (56.20) | 56 (74.67) |
| Incident Death | 8 (2.52) | 5 (2.07) | 3 (4.00) |
| MI | 21 (6.62) | 16 (6.61) | 5 (6.67) |
| MI,HF Hospitalization | 2 (0.63) | 1 (0.41) | 1 (1.33) |
| MI, Urgent Revas | 7 (2.21) | 7 (2.89) | 0 (0.00) |
| MI, Urgent Revas, Cardiac Death | 1 (0.32) | 0 (0.00) | 1 (1.33) |
| MI, Urgent Revas, HF Hospitalization | 1 (0.32) | 1 (0.41) | 0 (0.00) |
| Other Death | 40 (12.62) | 33 (13.64) | 7 (9.33) |
| Urgent Revas | 32 (10.09) | 31 (12.81) | 1 (1.33) |
| Urgent Revas, HF Hospitalization | 1 (0.32) | 1 (0.41) | 0 (0.00) |
19
Image /page/19/Figure/1 description: The image shows the title "Kaplan-Meier Curves for Population 1". The title is written in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is plain white.
Image /page/19/Figure/2 description: The image is a graph that shows the absolute risk of ACM/MACE as a function of follow-up time in days. There are two lines on the graph, one for values less than or equal to the 99th percentile and one for values greater than the 99th percentile. The graph shows that the absolute risk of ACM/MACE is higher for values greater than the 99th percentile. The number at risk is also shown in a table below the graph.
12. Conclusion
The Atellica® IM High-Sensitivity Troponin I (TnIH) assay is substantially equivalent in principle and performance to the currently marketed predicate device, the VITROS Troponin I ES Assay (K062838). The results of the clinical study provided in this submission support the addition of an indication for use as an aid in prognosis for all-cause mortality (ACM) and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS).