(49 days)
Not Found
Not Found
No
The summary describes a standard enzyme immunoassay test and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is for diagnostic purposes, specifically for detecting cardiac troponin-I to aid in the diagnosis of acute myocardial infarction, not for treating a condition.
Yes
The intended use explicitly states that the test is "as an aid in the diagnosis of acute myocardial infarction".
No
The device description is not found, but the intended use describes a "rapid enzyme immunoassay test" which strongly suggests a physical test kit or hardware component is involved, not just software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "rapid enzyme immunoassay test for the quantitative detection of cardiac troponin-I in serum and heparinized plasma." This involves testing biological samples (serum and plasma) in vitro (outside the body).
- Purpose: The purpose is "as an aid in the diagnosis of acute myocardial infarction." This is a diagnostic purpose, which is a key characteristic of IVDs.
- Sample Type: It analyzes biological samples (serum and plasma).
The other sections being "Not Found" or "Not Applicable" don't negate the core definition of an IVD based on the intended use and the type of test being performed.
N/A
Intended Use / Indications for Use
A rapid enzyme immunoasay test for the quantitative detection of cardiac troponin-I in serum and heparinized plaama as an aid in the diagnosis of acute myocardial infarction. This test is to be used in clinical and hospital laboratories and is not for Doctor's offices use.
Product codes
MMI
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
clinical and hospital laboratories
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 U.S. Department of Health & Human Services. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract image of a stylized caduceus, a symbol often associated with healthcare. The caduceus is depicted with three snakes intertwined around a staff.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 23 1997
Charles W. Gill Director of Research & Development Texas Immunology, Inc. . . . . 5400 Spur 248, University Park, Bldg. 2, Ste. 6 Tyler, Texas 75707
Re : K972094 Tarqet Cardiac Troponin-I Test Regulatory Class: II Product Code: MMI Dated: June 3, 1997 Received: June 4, 1997
Dear Mr. Gill:
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 regulations 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 requirement, as set forth in the Quality System Regulation (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 Requlations.
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 requlation (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/dsmamain.html".
sincerely yours,
Steven Ditman
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
TARGET CARDIAC TROPONIN-I TEST Device Name:
Indications For Use:
ﺘﺮ
A rapid enzyme immunoasay test for the quantitative detection of cardiac troponin-I in serum and heparinized plaama as an aid in the diagnosis of acute myocardial infarction. This test is to be used in clinical and hospital laboratories and is not for Doctor's offices use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
vision Sign-Off)
ion of Clinical Laboratory Devices
Number 9-72094
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)