(71 days)
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.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Spectral Cardiac STATus™ CK-MB-Myoglobin/Troponin I 3-in-1 test." This document is an approval letter and an "Indications for Use" statement, not a study report or clinical trial summary.
Therefore, it does not contain the acceptance criteria or the study details requested in your prompt. It only states that the device is substantially equivalent to legally marketed predicate devices and outlines its intended use.
To answer your questions, I would need access to the actual 510(k) submission document or a clinical study report for this device, which are not provided in the input text.
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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
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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)
§ 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.