(71 days)
Not Found
Not Found
No
The summary focuses on a qualitative immunoassay for cardiac markers and lacks any mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as an aid in diagnosis, which means it helps identify a condition rather than treat or manage it. Therapeutic devices are used for treatment or prevention of diseases.
Yes
The intended use explicitly states "[a]s an aid in the diagnosis of acute myocardial infarction".
No
The provided 510(k) summary describes a device for the qualitative determination of biomarkers in human blood, plasma, or serum. This strongly suggests a device that interacts with biological samples, which typically involves hardware components for sample handling, analysis, and detection (e.g., a reader, test strips, etc.). The lack of a "Device Description" section prevents definitive confirmation, but the intended use points away from a software-only device.
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 qualitative determination of CK-MB, myoglobin, and cardiac troponin I in human whole blood, plasma or serum". This involves testing biological samples (blood, plasma, serum) in vitro (outside the body) to obtain diagnostic information.
- Aid in Diagnosis: The purpose is to "aid in the diagnosis of acute myocardial infarction". This is a key characteristic of IVDs, which are used to provide information for diagnostic purposes.
The other sections being "Not Found" or irrelevant to the definition of an IVD (like image processing, AI, anatomical site, etc.) do not negate the fact that the intended use clearly describes an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
For the qualitative determination of CK-MB, myoglobin, and cardiac troponin I in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, pointof-care, and hospital settings.
Product codes
MMI, JHT, DDR
Device Description
Not Found
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
emergency room, critical care, point-of-care, and hospital settings.
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)
Not Found
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 9 2003
Dr. Nisar A. Shaikh Director of Quality Systems Spectral Diagnostics Inc. 135 The West Mall Toronto, Ontario Canada M9C 1C2
K030057 Trade/Device Name: Spectral Cardiac STATus™ CK-MB-Myoglobin/Troponin I 3-in-1 test Regulation Number: 21 CFR § 862.1215 Regulation Name: Immunoassay Method, Troponin Subunit, Chromatographic Separation, CPK Isoenzymes Regulatory Class: II Product Code: MMI, JHT, DDR Dated: January 3, 2003 Received: January 7, 2003
Dear Dr. Shaikh:
Re:
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). 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
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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
2
Spectral Diagnostics Inc. Spectral Cardiac STATus™ CK-MB/Myoglobin/Troponin I 3-in-1 510(k) Notification
KU3005 510(k) Number (if Known) : Not Known at this time
Device Name: Spectral Cardiac STATus™ CK-MB/Myoglobin/Troponin I 3-in-1 test
Indications for Use: For the qualitative determination of CK-MB, myoglobin, and cardiac troponin I in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, pointof-care, and hospital settings.
Ham
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030057
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Professional Use:
Prescription Use: (Per 21 CFR 801.109) Over the counter use: (Optional Format 1-2-96)