(126 days)
Not Found
No
The description focuses on fluorescence immunoassay technology and built-in control features, with no mention of AI or ML.
No.
The devices are diagnostic tools that aid in the diagnosis and assessment of various conditions by measuring specific biomarkers, not for treating or preventing disease.
Yes
The device is described as "an aid in the diagnosis of myocardial infarction (injury)" and "an aid in the diagnosis and assessment of severity of congestive heart failure", which are diagnostic purposes.
No
The device description clearly states it is a "single-use device containing murine monoclonal and polyclonal antibodies... labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers." This describes a physical, reagent-based assay, not a software-only device. While it uses a "Triage Meter" to measure and display results, the core diagnostic component is a physical test cartridge.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "quantitative determination" of various biomarkers (CK-MB, myoglobin, troponin I, BNP, D-dimer) in "EDTA whole blood and plasma specimens." These are biological specimens taken from the human body.
- Purpose: The test is used as an "aid in the diagnosis," "assessment of severity," and "risk stratification" of various medical conditions (myocardial infarction, heart failure, acute coronary syndromes, disseminated intravascular coagulation, thromboembolic events). This indicates the device is used to provide information for medical diagnosis and treatment decisions.
- Device Description: The device description details the components used to perform the assay on the biological specimens (antibodies, fluorescent dye, solid phase).
- Method: The method described is a "fluorescence immunoassay," which is a common technique used in in vitro diagnostics to measure substances in biological samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of a transplant, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Triage® Profiler S.O.B.TM (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peotide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.
The Triage® CardioProfilER® Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of Creatine Kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), an aid in the risk stratification of patients with heart failure, and an aid in the risk stratification of patients with acute coronary syndromes.
Product codes (comma separated list FDA assigned to the subject device)
NBC, JHX, DDR, MMI, DAP
Device Description
The Triage CardioProfilER Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myoglobin, murine monoclonal and goat polyclonal antibodies against troponin I and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are builtin control features that ensure that the test was performed properly and the reagents were functionally active.
The Triage Profiler S.O.B. Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myodlobin, murine monoclonal and qoat polyclonal antibodies against troponin I, murine monoclonal antibodies against D-dimer, and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that the test was performed properly and the reagents were functionally active.
The Test Cartridges are inserted into the Triage Meter and results for each analyte are measured and displayed on the display screen or printout. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 862.1117 B-type natriuretic peptide test system.
(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”
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510(k) Summary of Safety and Effectiveness
JUN ~ 6 2008
Triage® CardioProfilER® Panel Triage® Profiler S.O.B.™ (Shortness of Breath) Panel
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) number is:
Name and Address of Submitter 1.
| Company Name:
Address: | Biosite Incorporated
9975 Summers Ridge Road
San Diego, CA 92121 |
|---------------------------|------------------------------------------------------------------------|
| Telephone:
Telefax: | (858) 805-2154
(858) 695-7100 |
| Contact Person: | Dawn A. Allenby, Esq.
Manager, Regulatory Affairs |
| Date Summary Prepared: | June 2, 2008 |
2. Device Name and Classification
| Trade Name: | Triage CardioProfilER Panel |
|---|---|
| Common Name: | CardioProfilER Panel |
| Classification of Device: | 21 CFR 862.1117, |
| B-type natriuretic peptide test system | |
| Product Code: NBC |
21 CFR 862.1215,
Fluorometric Method, CPK or Isoenzymes
Product Code: JHX
21 CFR 866.5680,
Myoglobin, Antigen, Antiserum, Control
Product Code: DDR
21 CFR 862.1215,
Immunoassay Method, Troponin Subunit
Product Code: MMI |
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Trade Name:
Triage Profiler S.O.B. Panel
Common Name:
Classification of Device:
Profiler S.O.B. Panel
21 CFR 862.1117, B-type natriuretic peptide test system Product Code: NBC
21 CFR 862.1215. Fluorometric Method, CPK or Isoenzymes Product Code: JHX
21 CFR 866.5680, Myoglobin, Antigen, Antiserum, Control Product Code: DDR
21 CFR 862.1215, Immunoassay Method, Troponin Subunit Product Code: MMI
21 CFR 864.7320, Fibrinogen/Fibrin Degradation Products Assav Product Code: DAP
Predicate Device 3.
Biosite Triage BNP Test (K051787)
4. Device Description and Intended Use
The Triage CardioProfilER Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myoglobin, murine monoclonal and goat polyclonal antibodies against troponin I and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are builtin control features that ensure that the test was performed properly and the reagents were functionally active.
The Triage CardioProfilER Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of Creatine Kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of
2
severity of congestive heart failure (also referred to as heart failure), an aid in the risk stratification of patients with heart failure, and an aid in the risk stratification of patients with acute coronary syndromes.
The Triage Profiler S.O.B. Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myodlobin, murine monoclonal and qoat polyclonal antibodies against troponin I, murine monoclonal antibodies against D-dimer, and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that the test was performed properly and the reagents were functionally active.
The Triage Profiler S.O.B. Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coaqulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.
The Test Cartridges are inserted into the Triage Meter and results for each analyte are measured and displayed on the display screen or printout. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.
5. Comparison to Predicate Device
The devices and test methods described in this Premarket Notification for the Triage CardioProfilER Panel and the Profiler S.O.B. Panel are identical in principle, reagents and procedure to their predecessors. More specifically, the BNP assays included in these panels are identical to the BNP assay used in the Triage BNP Test (K051787). Moreover, the Triage BNP Test serves as the predicate method for the use of a circulating biomarker to provide prognostic information in patients with heart failure. Therefore, the use of the Triage CardioProfilER and the Profiler S.O.B. Panels as an aid in the risk stratification of patients with heart failure is substantially equivalent to the predicate method.
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Conclusion 6.
The information presented in this Premarket Notification demonstrates the substantial equivalence of the intended use claims of the Triage CardioProfilER Panel and the Triage Profiler S.O.B. Panel to the intended use claims of the Triage BNP Test (K051787) which has been reviewed and cleared through the 510(k) Premarket Notification process.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 6 2008
Biosite Incorporated c/o Ms. Dawn A. Allenby, Esq. Manager, Regulatory Affairs 9975 Summers Ridge Road San Diego, CA 92121
Re: K080269
Trade/Device Name: Triage® Profiler S.O.B.TM (Shortness of Breath Panel), Triage® CardioProfiler® Panel Regulation Number: 21 CFR§ 862.1117 Regulation Name: B-Type Natriuretic Peptide Test System Regulatory Class: Class II Product Code: NBC, JHX, DDR, MMI, DAP Dated: January 31, 2008 Received: March 19, 2008
Dear Ms. Allenby:
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 (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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K080269 510(k) Number (if known):
Device Name:
Triage® Profiler S.O.B. [M (Shortness of Breath) Panel
Indications for Use:
The Triage® Profiler S.O.B.TM (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peotide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.
AND/OR Over-The Counter Use Prescription Use (Per 21 CFR 801.109) (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Division Sign On
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of
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510(k) K080269
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Indications for Use
510(k) Number (if known): K080269
Device Name:
Triage® CardioProfilER® Panel
Indications for Use:
The Triage® CardioProfilER® Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of Creatine Kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), an aid in the risk stratification of patients with heart failure, and an aid in the risk stratification of patients with acute coronary syndromes.
Over-The Counter Use AND/OR Prescription Use (Per 21 CFR 801.109) (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
2 Page 1 of
510(k)