(68 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other indicators typically associated with AI/ML technology in medical devices. The description focuses on a qualitative determination of a biomarker.
No
The device is described as aiding in the diagnosis of acute myocardial infarction, which indicates a diagnostic rather than therapeutic purpose.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "as an aid in the diagnosis of acute myocardial infarction." Devices that aid in diagnosis are considered diagnostic devices.
Unknown
The provided text is a 510(k) summary template with "Not Found" for most sections, including the "Device Description". Without a description of the device, it is impossible to determine if it is software-only or includes hardware components.
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 in human whole blood, plasma or serum". This clearly indicates that the device is designed to test biological samples (blood, plasma, serum) outside of the human body to obtain diagnostic information. This is the core definition of an in vitro diagnostic device.
- Analyte: The device measures CK-MB, which is a biochemical marker used in the diagnosis of acute myocardial infarction. This is a common type of analyte measured by IVD devices.
- Diagnostic Aid: The intended use states it is "as an aid in the diagnosis of acute myocardial infarction". This further confirms its role in providing diagnostic information.
The other sections being "Not Found" do not negate the fact that the intended use clearly defines it as an IVD.
N/A
Intended Use / Indications for Use
For the qualitative determination of CK-MB in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.
Product codes
JHT
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, arranged in a way that they also resemble a bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 3 0 2002
Nisar Shaikh, Ph.D. Director of Quality Systems Spectral Diagnostics, Inc. 135-2 The West Mall Toronto. Ontario Canada M9C 1C2
K022409 Re:
Trade/Device Name: Spectral's Cardiac Status™ CK-MB Rapid Test Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHT Dated: July 22, 2002 Received: July 24, 2002
Dear Dr. Shaikh:
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 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.
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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 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
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Spectral Diagnostics Inc. Spectral's Cardiac Status™ CK-MB Rapid Test 510(k) Notification
510(k) Number (if Known): Not Known at this time
Device Name: Spectral's Cardiac Status™ CK-MB Rapid test
Indications for Use: For the qualitative determination of CK-MB in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022469
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Professional Use:
Prescription Use:
(Per 21 CFR 801.109)
OR
Over the counter use: (Optional Format 1-2-96)