(126 days)
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.
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 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.
This 510(k) summary (K080269) describes the Triage CardioProfilER Panel and the Triage Profiler S.O.B. Panel, which are fluorescence immunoassays used with Triage Meters for the quantitative determination of various cardiac and circulatory markers in EDTA whole blood and plasma specimens.
The submission focuses on establishing substantial equivalence to a predicate device, the Biosite Triage BNP Test (K051787), particularly for the use of BNP in risk stratification of heart failure patients.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain specific quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) for the Triage CardioProfilER Panel or the Triage Profiler S.O.B. Panel.
Instead, the submission states that:
- "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)."
- "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."
This indicates that the acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to the previously cleared predicate device (K051787) through comparison of their identical principles, reagents, and procedures, rather than presenting new performance data against specific numerical targets.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify any sample sizes used for a test set or data provenance for a study proving device performance. The submission relies on the substantial equivalence of the new devices to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No de novo study featuring a test set with ground truth established by experts is described in the provided document.
4. Adjudication Method for the Test Set
Not applicable. No de novo study featuring a test set with adjudication is described in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The devices are diagnostic assays, not AI-assisted interpretation tools for image analysis.
6. If a Standalone (Algorithm Only) Performance Study Was Done
The document does not describe a standalone performance study in the sense of an independent algorithm's performance. The devices are immunoassay panels that produce quantitative measurements. Their performance is indirectly addressed by claiming identity to previously-cleared assays within the predicate device.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance evaluation of the new devices, as it primarily relies on substantial equivalence. For the predicate device's clearance (K051787), it would have been expected that clinical diagnosis, pathology, or patient outcomes data were used as ground truth for establishing the performance characteristics of the individual assays (CK-MB, myoglobin, troponin I, BNP, D-dimer).
8. The Sample Size for the Training Set
Not applicable. The document does not describe an AI or machine learning model that would require a "training set" in the context of typical AI device submissions. These are immunoassay panels.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no mention of a training set or its associated ground truth establishment methods for these immunoassay panels.
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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 Incorporated9975 Summers Ridge RoadSan 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 systemProduct Code: NBC21 CFR 862.1215,Fluorometric Method, CPK or IsoenzymesProduct Code: JHX21 CFR 866.5680,Myoglobin, Antigen, Antiserum, ControlProduct Code: DDR21 CFR 862.1215,Immunoassay Method, Troponin SubunitProduct 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
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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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Page 2 -
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)
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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)
§ 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.”