(24 days)
Not Found
No
The description focuses on fluorescence immunoassay technology and quantitative determination of biomarkers, with no mention of AI or ML.
No
The device is described as an immunoassay used for diagnostic purposes, specifically aiding in the diagnosis and assessment of conditions like myocardial infarction and heart failure, rather than providing treatment.
Yes
The device explicitly states its intended use is "as an aid in the diagnosis of myocardial infarction (injury), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), and the risk stratification of patients with acute coronary syndromes." This directly indicates a diagnostic purpose.
No
The device description explicitly states it is a "fluorescence immunoassay to be used with the Triage® Meter," indicating it is a physical test kit and a meter, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used for the "quantitative determination" of specific biomarkers (Creatine Kinase MB, myoglobin, troponin I, and B-type natriuretic peptide) in "EDTA whole blood and plasma specimens." These are biological samples taken from the body.
- Purpose: The test is used "as an aid in the diagnosis of myocardial infarction (injury), the diagnosis and assessment of severity of congestive heart failure, and the risk stratification of patients with acute coronary syndromes." This clearly indicates the device is used to provide information about a patient's health status based on testing samples outside the body.
- Method: It is described as a "fluorescence immunoassay," which is a common technique used in in vitro diagnostic testing.
The definition of an IVD is a medical device that is 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 concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The Triage® Cardio ProfilER is a fluorescence immunoassay to be used with the Triage® Meter 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), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), and the risk stratification of patients with acute coronary syndromes.
The Triage® Cardiac Panel is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB, myoglobin and troponin I in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnesis of myocardial infarction (injury).
Product codes (comma separated list FDA assigned to the subject device)
JHX, MMI, DDR, NBC
Device Description
The Triage® Cardio ProfilER is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB, myoqlobin, troponin I, and B-type natriuretic peptide in EDTA whole blood and plasma specimens.
The Triage® Cardiac Panel is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB, myoglobin and troponin I in EDTA whole blood and plasma specimens.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 862.1117 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.”
0
510(k) Summary of Safety and Effectiveness
Ko 70286
Triage® Cardio ProfilER / Triage® Cardiac Panel
FEB 2 1 2003
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: (To be determined)
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: | 1/27/03 |
B. Device Names
-
- Trade Name
Triage® Cardio ProfilER / Triage® Cardiac Panel
- Trade Name
-
- Common / Usual Name
Triage® Cardio ProfilER / Triage® Cardiac 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) (Triage® Cardio ProfilER) Product Code NBC
C. Predicate Devices
Triage® Cardiac Panel (K973126)
1
Triage® BNP Test (K021317)
D. Device Description and Intended Use
The Triage® Cardio ProfilER is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB, myoqlobin, 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), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), and the risk stratification of patients with acute coronary syndromes.
The Triage® Cardiac Panel is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB, myoglobin and troponin I in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury).
E. Summary of Comparison Data
The Triage® Cardio ProfilER is a combination of the two predicate devices. The only differences between the Triage® Cardio ProfilER and the predicate devices is that the Triage® Cardio uses EDTA as an anticoagulant, while the Triage® Cardiac Panel uses heparin as an anticoagulant, and the troponin assay has a lower analytical sensitivity than the troponin assay on the Triage® Cardiac Panel. The only difference between the modified Triage® Cardiac Panel and the Triage® Cardio ProfilER is the absense of a BNP assay on the Triage® Cardiac Panel.
F. Conclusion
The design control process led to a determination that the Triage® Cardio ProfilER and Triage® Cardiac Panel are substantially equivalent to the previously cleared predicate devices. The evaluation has led to assurance that the Triage® Cardio ProfilER and Triage® Cardiac Panel are safe and effective for their intended uses and no new issues of safety and effectiveness have been raised.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle's head, with three lines representing the feathers. The eagle's head is facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 1 2003
Jeffery R. Dahlen, Ph.D. Principal Scientist Clinical & Regulatory Affairs Biosite® Inc. 11030 Roselle Street San Diego, CA 92121
Re: K030286
Trade/Device Name: Triage® Cardio ProfilER/Triage® Cardiac Panel Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: NBC; JHX; MMI; DDR Dated: January 27, 2003 Received: January 28, 2003
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. Iisting 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 (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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Ko30286 510(k) Number (if known): (to be determined)
Device Name: Triage® Cardio ProfilER / Triage® Cardiac Panel
Indications For Use:
The Triage® Cardio ProfilER is a fluorescence immunoassay to be used with the Triage® Meter 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), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), and the risk stratification of patients with acute coronary syndromes.
The Triage® Cardiac Panel is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB, myoglobin and troponin I in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnesis of myocardial infarction (injury).
Acan (Arabili (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_KO3078
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)