(67 days)
Not Found
No
The summary describes a fluorescence immunoassay and meter for quantitative determination of biomarkers. There is no mention of AI, ML, or image processing, and the performance studies refer back to a previous 510(k) without indicating any changes related to advanced algorithms.
No
The device is described as a diagnostic immunoassay used to aid in the diagnosis and assessment of various medical conditions, not to treat them.
Yes
The device is described as an "aid in the diagnosis" of several conditions, including myocardial infarction, heart failure, and disseminated intravascular coagulation, which directly aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a fluorescence immunoassay to be used with a hardware meter (Triage® Meter Plus) and analyzes biological specimens (blood and plasma). This indicates it is a hardware-based diagnostic device, 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 creatine kinase MB, myoglobin, troponin I, B-type natriuretic pentide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens." This involves testing biological samples (blood and plasma) in vitro (outside the body) to provide information for diagnosis and assessment.
- Device Description: The "Device Description" further confirms this by describing it as a "fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of..." the same analytes in the same sample types. Immunoassays are a common type of IVD test.
- Sample Type: The device uses "EDTA whole blood and plasma specimens," which are biological samples tested in vitro.
The core function of the device is to analyze biological samples to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TriageR Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the TriageR Meter Plus for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic pentide, 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 having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism, 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 1, B-type natriuretic peptide, and cross-linked fibrin dearadation 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 having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism, and an aid in the risk stratification of patients with acute coronary syndromes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
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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).
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DEC - 7 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.
K040427 K042723 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: | 9/30/04 |
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
-
- Classification Name
· Fluorometric Method, CPK or Isoenzymes (862.1215) Product Code JHX
- Classification Name
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® Profiler S.O.B. Panel (K040437) K 04-2 7 2 3
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 1, B-type natriuretic peptide, and cross-linked fibrin dearadation 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 having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism, and an aid in the risk stratification of patients with acute coronary syndromes.
E. Summary of Comparison Data
There have been no changes to the test performance, design, reagents and manufacture. These are identical to 510(k) document number K040437. The indications for use have been revised for clarity.
F. Conclusion
The revision to the indications for use raises no new issues of safety and effectiveness for the Triage Profiler S.O.B. Panel. Because there were no modifications to the test performance, design, reagents and manufacture, the test system is substantially equivalent to the predicate method.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three lines representing snakes intertwined around a staff.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 7 2004
Jeffrey R. Dahlen, Ph.D. Director, Clinical & Regulatory Affairs Biosite Incorporated 11030 Roselle Street San Diego, CA 92121
Re: K042723
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, MMI, JHX, DDR, NBC Dated: September 30, 2004 Received: October 1, 2004
Dear Dr. Dahlen:
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) rms lotest 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, rr you stions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation 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 Division of Small Manufacturers, 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,
Cornelia B. Lorkes
Cornelia B. Rooks, MA Acting 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): IBO K042723
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 pentide, 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 having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism, and an aid in the risk stratification of patients with acute coronary syndromes.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042723