(127 days)
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No
The summary describes a fluorescence immunoassay and its performance characteristics, with no mention of AI or ML technologies.
No
The device is described as a diagnostic immunoassay used to aid in the diagnosis and assessment of various medical conditions, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device 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 assessment and evaluation of patients suspected of disseminated intravascular coagulation (including pulmonary embolism) and other non-specific thromboembolic events, and an aid in the risk stratification of patients with acute coronary syndromes." This clearly indicates its diagnostic purpose.
No
The device is a fluorescence immunoassay panel used with a meter, indicating it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is used for the quantitative determination of various biomarkers in EDTA whole blood and plasma specimens. This is a key characteristic of an in vitro diagnostic device, as it analyzes samples taken from the human body outside of the body itself.
- Device Description: The "Device Description" further confirms that it's a "fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of..." the listed biomarkers in EDTA whole blood and plasma specimens. This reinforces the in vitro nature of the testing.
- Performance Studies: The "Summary of Performance Studies" describes method comparisons using specimens, which are samples taken from patients. This is consistent with IVD testing.
- Predicate Devices: The listed predicate devices (Triage® Cardiac Panel, Triage® BNP Test, Dade Behring Stratus CS DDMR TestPak) are all known IVD devices. This further supports the classification of the Triage® Profiler S.O.B. Panel as an IVD.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue, taken from the human body, to detect diseases, conditions, or infections. The provided information clearly aligns with this definition.
N/A
Intended Use / Indications for Use
The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus 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 assessment and evaluation of patients suspected of disseminated intravascular coagulation (including pulmonary embolism) and other non-specific thromboembolic events, and an aid in the risk stratification of patients with acute coronary syndromes.
Product codes
JHX, MMI, DDR, NBC, GHH, DAP
Device Description
The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus 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.
Mentions image processing
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A method comparison of the CK-MB, troponin I, myoglobin, and BNP assays demonstrated that the assays on the Triage Profiler S.O.B. panel are equivalent to the same assays in the predicate methods. A method comparison of D-dimer results was performed using 180 specimens throughout the measurable range of the test. A Passing-Bablok regression analysis of the results yielded a linear relationship with a slope of 0.999, an intercept of -85.89 and a correlation coefficient of 0.92. The analytical performance characteristics for each of the assays were equivalent with the predicate methods.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).
0
JUN 2 5 2004
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
K040437 510(k) Number:
A. Name and Address of Submitter
| Company Name: | Biosite Incorporated |
|---|---|
| Address: | 11030 Roselle Street |
| San Diego, CA 92121 | |
| Telephone: | (858) 455-4808 |
| Fax: | (858) 535-8350 |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | 6/24/04 |
B. Device Names
-
- Trade Name
Triage® Profiler S.O.B. Panel
- Trade Name
-
- Common / Usual Name
Triage® Profiler S.O.B. Panel
- Common / Usual Name
3. Classification Name
Fluorometric Method, CPK or Isoenzymes (862.1215) Product Code JHX
Immunoassay Method, Troponin Subunit (862.1215) Product Code MMI
Myoglobin, Antigen, Antiserum, Control (866.5680) Product Code DDR
Test, Natriuretic Peptide (862.1117) Product Code NBC
Fibrinogen/Fibrin Degradation Products Assay (864.7320) Product Code GHH
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C. Predicate Devices
Triage® Cardiac Panel (K973126) Triage® BNP Test (K021317) Dade Behring Stratus CS DDMR TestPak (K022976)
D. Device Description and Intended Use
The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus 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 (iniury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the assessment and evaluation of patients suspected of disseminated intravascular coagulation (including pulmonary embolism) and other non-specific thromboembolic events, and an aid in the risk stratification of patients with acute coronary syndromes.
E. Summary of Comparison Data
A method comparison of the CK-MB, troponin I, myoglobin, and BNP assays demonstrated that the assays on the Triage Profiler S.O.B. panel are equivalent to the same assays in the predicate methods. A method comparison of D-dimer results was performed using 180 specimens throughout the measurable range of the test. A Passing-Bablok regression analysis of the results yielded a linear relationship with a slope of 0.999, an intercept of -85.89 and a correlation coefficient of 0.92. The analytical performance characteristics for each of the assays were equivalent with the predicate methods.
F. Conclusion
The assays on the Triage Profiler S.O.B. Panel are substantially equivalent to the predicate methods. The evaluation has led to assurance that the Triage Profiler S.O.B. Panel is safe and effective for the intended use and no new issues of safety and effectiveness have been raised.
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Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three wing-like shapes and a tail.
JUN 2 5 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jeffrey R. Dahlen, Ph.D. Director, Clinical & Regulatory Affairs Biosite Incorporated 11030 Roselle Street San Diego, CA 92121
K040437 Re:
Trade/Device Name: Triage® Profiler S.O.B. Panel Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/Fibrin degradation products assay Regulatory Class: Class II Product Code: DAP, NBC,MMI, JHX, DDR Dated: June 1, 2004 Received: June 2, 2004
Dear Dr. Dahlen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreas, 1976, the enactment date of the Medical Device Amendments, or to conimered pror to may 20, 2017 11:11 accordance with the provisions of the Federal Food, Drug, de necs that have been recuire approval of a premarket approval application (PMA). and Coometer fore, market the device, subject to the general controls provisions of the Act. The I va may, therefore, mains of the Act include requirements for annual registration, listing of general controls proficturing 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 it may be subject to bach additions beend 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr has Intatutes and regulations administered by other Federal agencies. You must or any I vith 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) I ms loter will and in your of substantial equivalence of your device of your device to a legally prematication: "The Blassification 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, II you desire spoolitie niemand advertising of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. 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 Tou may obtain other getterers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, U.S., Div.
Jean M. Cooper, MS, 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
510(k) Number (if known): K040437
Device Name: Triage® Profiler S.O.B. Panel
Indications For Use:
The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus 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 assessment and evaluation of patients suspected of disseminated intravascular coagulation (including pulmonary embolism) and other non-specific thromboembolic events, and an aid in the risk stratification of patients with acute coronary syndromes.
| Prescription Use | |
|---|---|
| ------------------ | -- |
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040437
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