(52 days)
Not Found
Not Found
No
The summary describes a rapid qualitative immunoassay test, which does not typically involve AI/ML. There are no mentions of AI, ML, image processing, or data analysis techniques indicative of AI/ML.
No
Explanation: This device is an in vitro diagnostic product intended to aid in the diagnosis of myocardial infarction. It does not provide therapy or treatment.
Yes
The device is described as an "in vitro diagnostic product" that aids "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 biological samples, which inherently involves physical components for sample handling and analysis, not just software.
Yes, based on the provided information, the Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states it is "intended for use as an in vitro diagnostic product".
- Nature of the Test: It determines the presence of specific substances (CK-MB and myoglobin) in biological samples (serum, whole blood, or plasma) to aid in the diagnosis of a medical condition (myocardial infarction). This is the core function of an in vitro diagnostic device.
- Care Setting: It is intended for use in clinical settings like emergency rooms, critical care, point of care, or hospitals, which are typical environments for IVD testing.
The information provided clearly aligns with the definition and purpose of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB and myoglobin in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.
Product codes
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 or hospital settings.
Professional Use X
Prescription Use X (Per 21 CFR 801.109)
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
Received: April 06, 1999
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes that resemble a person with outstretched arms, representing health and well-being. The logo is black and white.
Food and Drug Administration Jemo Kang, Ph.D. 2098 Gaither Road MAY 2 8 1999 President Rockville MD 20850 Princeton Biomeditech Corp. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 Re : K991299 Trade Name: CardiacStAus CK-MB/Myoglobin Rapid One-Step Test . Requlatory Class: II Product Code: JHT, DDR Dated: March 31, 1999
Dear Mr. 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 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). 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 reqistration, 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 Regulations, 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.
1
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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 "http://www.fda.gov/cdrh/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
Princeton BioMeditech Corp Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test 510(k) Notification
K 991399
510(k) Number (if Known): Not Known at this time
Device Name : Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test
Indications for Use:
The Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB and myoglobin in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.
Dean Cos
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991299
(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 X (Per 21 CFR 801.109) OR
Over-The Counter Use (Optional Format 1-2-96)