(39 days)
Not Found
Not Found
No
The summary describes a rapid diagnostic test for cardiac markers, which is a chemical assay, not a software-based device. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
This device is an in vitro diagnostic product used to aid in the diagnosis of myocardial infarction by detecting biomarkers. It does not provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as an in vitro diagnostic product" and functions "as an aid in the diagnosis of myocardial infarction."
No
The device is described as an "in vitro diagnostic product" for the rapid qualitative determination of biomarkers in human samples. This strongly implies a physical test kit or assay, not a software-only device.
Yes, based on the provided information, the Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as an in vitro diagnostic product".
- Purpose: It is designed to perform a test on human biological samples (whole blood, serum, and plasma) outside of the body ("in vitro") to aid in the diagnosis of a medical condition (myocardial infarction).
These are the key characteristics of an IVD.
N/A
Intended Use / Indications for Use
The Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB, myoglobin and troponin I in human whole blood, serum, and plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.
Product codes
JFX, MMI, DEA
Device Description
Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL ୧
Jemo Kang, Ph.D. . President Princeton BioMeditech Corporation P.O. Box 7139 08543-7139 Princeton, New Jersey
K981882 Re : Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test Requlatory Class: II Product Code: JFX, MMI, DEA May 26, 1998 Dated: May 28, 1998 Received:
Dear Dr. Kang:
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, Drug, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 Failure to Administration (FDA) will verify such assumptions. 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 requlations.
1
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 "dsmo@fdadr.cdrh.fda.qov".
Sincerely yours,
Steven Autman
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
2
Princeton BioMeditech Corp Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test 510(k) Notification
510(k) Number (if Known) : Not Known at this time
Device Name : Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test
Indications for Use:
The Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB, myoglobin and troponin I in human whole blood, serum, and plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Professional use: X
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use (Optional Format 1-2-96)
Caul Benson/Alfred Montgomery
(Division Sign-Off) Division of Clinical 510(k) Number