(51 days)
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No
The summary describes a reagent for a quantitative determination of a substance in serum, which is a chemical analysis and does not typically involve AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No.
The device is an in-vitro diagnostic product for determining creatine kinase in human serum, not for treating any condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is an "in-vitro diagnostic product."
No
The device is an in-vitro diagnostic reagent, which is a chemical substance used in laboratory tests, not a software-only medical device.
Yes, the provided text explicitly states that the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section clearly says: "The Intersect CK Reagent is an in-vitro diagnostic product intended for use in the quantitative determination of creatine kinasc in human serum."
N/A
Intended Use / Indications for Use
The Intersect CK Reagent is an in-vitro diagnostic product intended for use in the quantitative determination of creatine kinasc in human serum.
Product codes
পদ্মন
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
FEB 1 3 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark E. Legaz, Ph.D., DABCC · President, Clinical Biochemist Intersect Systems, Inc. P.O. Box 2219 Longview, Washington 98632
Re : K974833 CK-NAC Reagent Requlatory Class: II Product Code: ପଦ୍ଧନ December 18, 1997 Dated: Received: December 24, 1997
Dear Dr. Legaz:
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 Requlations, Title 21, Parts 800 to 895. ਜੋ 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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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 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 Sitman
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: K974833
125
Device Name : Creatine Phosphate/Creatine Kinase or isoenzymes test system (CFR § 862.1215)
Common Name of Device: CK Reagent
Indications for Use: The Intersect CK Reagent is an in-vitro diagnostic product intended for use in the quantitative determination of creatine kinasc in human serum.
(Division Borge
510(x) Namber
(Division of Simbal Tank
Programs