(47 days)
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No
The summary does not contain any keywords or descriptions related to AI or ML. The intended use is a quantitative measurement of biomarkers, which is typically performed using standard laboratory techniques.
No
The device is used for quantitative measurement of biomarkers to aid in the diagnosis of myocardial infarction, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended for the quantitative measurement of biomarkers (CK-MB, Myoglobin, and Troponin-I) in whole blood to aid in the diagnosis of myocardial infarction, which is a diagnostic purpose.
No
The provided 510(k) summary describes a device that measures biomarkers (CK-MB, Myoglobin, Troponin-I) in whole blood. This strongly implies the use of a physical component (likely an analyzer or test strip) to interact with the blood sample and perform the measurement, which would make it a hardware device, not software-only. The lack of a device description prevents definitive confirmation, but the intended use points away from a software-only classification.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the quantitative measurement of CK-MB, Myoglobin and Troponin-I in heparinized whole blood." This involves testing biological samples (whole blood) in vitro (outside the body) to obtain diagnostic information.
- Diagnostic Purpose: The intended use also states "To be as an aid in the diagnosis of myocardial infarction." This clearly indicates the device is used for diagnostic purposes.
These two points are the core characteristics of an In Vitro Diagnostic device. The lack of other information (device description, performance studies, etc.) doesn't negate its classification as an IVD based on the provided intended use.
N/A
Intended Use / Indications for Use
For the quantitative measurement of CK-MB, Myoglobin and Troponin-I in heparinized whole blood. To be as an aid in the diagnosis of myocardial infarction.
Product codes
JHX, MMI, DDR
Device Description
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three flowing lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
OCT - 6 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
John F. Bruni, Ph.D. Director, Clinical and Regulatory Affairs Biosite Diagnostics 11030 Roselle Street San Diego, California 92121
Re : K973126 The Triage® Cardiac Panel Requlatory Class: II Product Code: JHX, MMI, DDR Dated: August 19, 1997 Received: August 20, 1997
Dear Dr. Bruni:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಕ್ಕೆ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device mav require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director ______ Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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5 IO(k) Number if known) _
Device Name: Triage® Cardiac Panel, Triage® Troponin-I, Triage® CK-MB, Triage® Myoglobin, Triage® Conce Namel Magger - Trage® Troponing Triage - Stephine, Pringe - Myoglobin and CK-MB
Troponin and Myoglobin, Triage® Troponin-I and CK-MB and Triage® Myoglobin and CK-MB
indications for Use:
For the quantitative measurement of CK-MB, Myoglobin and Troponin-I in heparinized whole blood. To be as an aid in the diagnosis of myocardial infarction.
(I'LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) -
(Division Sign-Off)
Division of Clinical Laborator Devices) 26
510(k) Number. 97
Prescription Use
Over-The Counter Use
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