(54 days)
Not Found
Not Found
No
The summary describes a reagent for a laboratory test and contains no mention of AI or ML.
No
The device is a reagent used for diagnostic assessment, not for treating a disease or condition.
Yes
The device is used in the "assessment" of diseases, which indicates a diagnostic purpose.
No
The 510(k) summary describes a "Creatine kinase Reagent," which is a chemical substance used in laboratory testing. This is a physical component, not software. The summary provides no information about any software component.
Based on the provided information, the device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the Creatine kinase Reagent is "to be used in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy." This strongly suggests that the reagent is used to test biological samples (like blood or serum) taken from the body to provide information about a person's health status. This is the core function of an IVD.
While the "Device Description" is not found, the nature of a "Creatine kinase Reagent" further supports the IVD classification. Reagents are substances used in chemical reactions, and in a diagnostic context, they are typically used to measure the presence or amount of specific substances in biological samples.
The absence of information about image processing, AI/ML, imaging modality, anatomical site (in the context of imaging), patient age range, intended user, training/test sets, performance studies, key metrics, and predicate/reference devices does not contradict the IVD classification. These details are often more relevant for imaging devices or devices that utilize complex algorithms.
Therefore, based on the intended use and the nature of a "reagent" used for assessing diseases, it is highly probable that this device is an IVD.
N/A
Intended Use / Indications for Use
The Creatine kinase Reagent is to be used in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.
Product codes
JHX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac and skeletal muscle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of several curved lines.
FEB 25 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Charles C. Allain, Ph.D. .AC Biochemicals, Inc. 17955 Sky Park Circle, Suite J Irvine, California 92614
K980012 Re : Creatine Kinase Reagent Requlatory Class: II Product Code: JHX December 20, 1997 Dated: Received: January 2, 1998
Dear Dr. Allain:
regulations.
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, Druq, 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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
1
Paqe 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/dsmamain.html".
sincerely yours,
Steven Litman
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
80012
510(k) Number (if known):
Device Name: Creatine kinase Reagent
Indications For Use:
The Creatine kinase Reagent is to be used in the assessment of cardiac and skeletal
s and see and states and collection and musele dystrophy The Creatine Knase Reagent is to oc assul in also and muscle dystrophy.
muscle diseases, including myocardial infarction and muscle dystrophy.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 980012
Concurrence of CDRH, Office of Device Evaluation (ODE)
アrescription Use シ (Per 21 CFR 801.109) OR
Over-The-Counter Use
Division
Confidential
Division
(H) Num