(60 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The "Intended Use / Indications for Use" section states that the device is for "qualitative determination of cardiac troponin I (cTnI) and myoglobin," which means it is a diagnostic device used to identify specific substances in the body, not to treat a medical condition.
Yes
The "Intended Use / Indications for Use" states "For the qualitative determination of cardiac troponin I (cTnI) and myoglobin in numali whole blood,..." which indicates it is used to identify the presence of specific substances in the body, a key function of a diagnostic device.
No
The intended use describes the qualitative determination of biomarkers in whole blood, which strongly suggests a physical testing component is involved, not just software analysis. The lack of a device description prevents confirmation, but the nature of the test 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 cardiac troponin I (cTnI) and myoglobin in numali whole blood, prasilia of the many of the of-care, and hospital settings." This describes a test performed on biological samples (whole blood) in vitro (outside the body) to provide diagnostic information (qualitative determination of cTnI and myoglobin).
- Sample Type: The device uses "whole blood," which is a biological specimen.
- Analytes: It measures "cardiac troponin I (cTnI) and myoglobin," which are biomarkers used in medical diagnosis.
These characteristics are all hallmarks of an In Vitro Diagnostic device. The fact that it's intended for use in "point-of-care, and hospital settings" further supports its role in providing diagnostic information.
N/A
Intended Use / Indications for Use
For the qualitative determination of cardiac troponin I (cTnI) and myoglobin in human whole blood, plasma or serum as an aid in the diagnosis of myocardial infarction (MI). The test is for in vitro diagnostic use in physician's office, point-of-care, and hospital settings.
Product codes
MMI, DEA
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
physician's office, 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Nisar A. Shaikh Director of Quality Systems Spectral Diagnostics Inc. 135-2 The West Mall Toronto, Ontario M9C 1C2 CANADA
MAY 2 4 2002
K020950 Re:
Trade/Device Name: Spectral's 2 in 1 (TnI-Myo) test Regulation Numbers: 21 CFR 862.1215; 21 CFR 866.5680 Regulation Names: Creatine phosphokinase/creatine kinase or isoenzymes test system; Myoglobin immunological test system Regulatory Class: Class II; Class II Product Code: MMI; DEA Dated: March 22, 2002
Dear Dr. Shaikh:
Received: March 25, 2002
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 -
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 legally marketed notification. The I Dri imating of succion 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 (2) CFR Part 801 and 1 II you desire specific acrice for your astic devices), please contact the Office of Compliance at additionally 807.10 for in viue allestions on the promotion and advertising of your device, (301) 594-4536. Truditional ) , IST 453-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Spectral Diagnostics Inc. Spectral's 2 in 1 (TnI-Myo) Test 510(k) Notification
510(k) Number (if Known) : Not Known at this time
Device Name : Spectral's 2 in 1 (TnI-Myo) test
Indications for Use: For the qualitative determination of cardiac troponin I
ndications for the top the belocked blood, plasma or serum as an aid in the Indications for Use: For the quality coocorative coocorative as an aid in the (cTnI) and myoglobin in numali whole blood, prasilia of the many of the of-care, and hospital settings.
Jean Cooper
(Division Sign-
Division of Clin.
vices
510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Professional Use: X
OD
Over the counter use: (Optional Format 1-2-96)
್ಕೆ
Prescription Use: X (Per 21 CFR 801.109) OR
SDI Ref #: R-003/2002-510K