(35 days)
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No
The document describes a reagent for a clinical chemistry analyzer, which is a laboratory test, not a device that typically incorporates AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
Explanation: This device is a reagent used for diagnostic purposes (measuring creatine kinase levels to aid in diagnosing conditions like myocardial infarction and muscular dystrophy), not for providing therapy or treatment.
Yes
The device is used for the quantitative determination of creatine kinase activity, and these measurements are explicitly stated to be "used in the diagnosis and treatment of myocardial infarction and muscle diseases." This indicates its role in identifying or confirming medical conditions.
No
The device described is a reagent, which is a chemical substance used in a laboratory test, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement clearly indicates that the Olympus Creatine Kinase reagent is used for the "quantitative determination of creatine kinase activity in human serum and plasma." This is a diagnostic test performed on biological samples (serum and plasma) outside of the body (in vitro) to aid in the diagnosis and treatment of conditions like myocardial infarction and muscular dystrophy. This aligns perfectly with the definition of an In Vitro Diagnostic device.
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Intended Use / Indications for Use
The Olympus Creatine Kinase reagent is intended for use in Olympus automated clinical Analyzers for the quantitative determination of creatine kinase activity in human serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Product codes
CGS
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 3 2004
Ms. Bev Harding RA Analyst Olympus America Inc. 3131 West Royal Lane Irving, TX 75063-3104
Re: K043202
Trade/Device Name: Olympus Creatine Kinase Reagent Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: CGS Dated: November 17, 2004 Received: November 18, 2004
Dear Ms. Harding:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and my Jorne FDA finding of substantial equivalence of your device to a legally premained predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may ovail Manufacturers, International and Consumer 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,
Carol C., Benam for
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Olympus Creatine Kinase Reagent. Device Name:
Indications for Use:
The Olympus Creatine Kinase reagent is intended for use in Olympus automated clinical The Organisation of creatify the quantitative determination of creatine kinase activity in human serum and plasma.
Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Carol Benam
Division of Off
Offici- or in Vitro Diganostic e Evaluation and Safety
571338 K043202
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)