(188 days)
Not Found
Not Found
No
The description focuses on standard electrophoretic separation and densitometric quantitation, with no mention of AI or ML terms or processes.
No
The device is described as a kit for identifying and quantifying creatine kinase isoenzymes, which are used as biochemical markers for diagnosing myocardial infarction. It is an in vitro diagnostic (IVD) device used in a clinical laboratory for diagnostic purposes, not for treating or preventing a disease.
Yes
The device is described as a kit for the identification and quantitation of creatine kinase (CK) isoenzymes, particularly CK-MB, which is a marker for distinguishing patients with acute myocardial infarction (AMI). The text explicitly states that the assay of CK isoenzymes is used to "confirm or rule out the diagnosis of MI, assess its severity and monitor patient's condition." These actions directly relate to diagnosing and monitoring a medical condition.
No
The device description is not found, but the intended use describes a laboratory assay involving electrophoresis on gels followed by densitometry, which are hardware-based processes.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the kit is for the "identification and quantitation of the three creatine kinase (CK) isoenzymes" using electrophoresis on biological samples (implied by the context of diagnosing myocardial infarction). This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Clinical Context: The description explicitly links the use of the kit to diagnosing acute myocardial infarction (AMI) and monitoring patient condition, which are clinical applications.
- Laboratory Use: The intended user is a "Clinical Laboratory," which is where IVD tests are typically performed.
The fact that it analyzes biological samples (blood, implied by the context of CK isoenzymes) outside of the body to provide diagnostic information is the key indicator of it being an IVD.
N/A
Intended Use / Indications for Use
All Sebia's Hydragel ISO-CK kits are intended for the identification and quantitation of the three creatine kinase (CK) isoenzymes. MM. MB and BB. by electrophoresis on alkaline buffered agarose gels followed by a densitometry.
The creatine kinase (CK) isoenzyme, CK-MB, is primarily released from a damaged heart muscle. It is one of the earliest markers for distinguishing patients with acute myocardial infarction o(AMI) from those with other coronary syndromes and episodes with similar symptoms.
Biochemical assays have been, and remain so, the most reliable means of detecting myocardial injury. However, no single biochemical marker can alone give a complete picture of myocardial injury and its extent. Therefore, the assay of CK isoenzymes is often used in tandem with the assay of LD isoenzymes, which are released slower from the injured heart muscle and remain. Ionger in circulation, to confirm or rule out the diagnosis of MI, assess its severity and , monitor patient's condition.
The principles of HYDRAGEL ISO-CK assays are: the electrophoretic separation of the CK isoenzymes, the use of a specific chromogenic substrate for the CK catalyzed visualization reaction, and densitometric quantitation of the electrophoregrams.
Product codes
CGS
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
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Description of the training set, sample size, data source, and annotation protocol
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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 image of three wavy lines, resembling a bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 9 1999
Borek Janik, Ph.D. Official Correspondent Morax 13805 Waterloo Chelsea, Michigan 48118
Re: K992148
Trade Name: Hydragel ISO-CK Kit, Hydragel 7 ISO-CK Kit, Hydragel ISO-CK 15/30 Kit, and Hydragel Mini ISO-CK Kit Regulatory Class: II Product Code: CGS Dated: October 27, 1999 Received: October 29, 1999
Dear Dr. Janik:
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 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (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 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 regulations.
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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
Page 1 of 1
510(k) Number (if known):
Device name:
HYDRAGEL - MINI ISO-CK Kit HYDRAGEL ISO-CK Kit HYDRAGEL 7 ISO-CK Kit HYDRAGEL ISO-CK 15/30 Kit
Indications For Use:
All Sebia's Hydragel ISO-CK kits are intended for the identification and quantitation of the three creatine kinase (CK) isoenzymes. MM. MB and BB. by electrophoresis on alkaline buffered agarose gels followed by a densitometry.
The creatine kinase (CK) isoenzyme, CK-MB, is primarily released from a damaged heart muscle. It is one of the earliest markers for distinguishing patients with acute myocardial infarction o(AMI) from those with other coronary syndromes and episodes with similar symptoms.
Biochemical assays have been, and remain so, the most reliable means of detecting myocardial injury. However, no single biochemical marker can alone give a complete picture of myocardial injury and its extent. Therefore, the assay of CK isoenzymes is often used in tandem with the assay of LD isoenzymes, which are released slower from the injured heart muscle and remain. Ionger in circulation, to confirm or rule out the diagnosis of MI, assess its severity and , monitor patient's condition.
The principles of HYDRAGEL ISO-CK assays are: the electrophoretic separation of the CK isoenzymes, the use of a specific chromogenic substrate for the CK catalyzed visualization reaction, and densitometric quantitation of the electrophoregrams.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Jean Cooper | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory/Devices | |
| 510(k) Number | K992148 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |
at 1-2-96)