(221 days)
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No
The 510(k) summary describes a liquid reagent for a standard laboratory test and contains no mention of AI or ML technology.
No
The device is an in vitro diagnostic test for measuring creatine kinase activity, which is used in diagnosis and treatment monitoring, but not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagent is for an "in vitro diagnostic test" and that measurements are "used in the diagnosis and treatment of myocardial infarction and muscle diseases."
No
The device description clearly states it is a "Creatine Kinase Liquid Reagent," which is a chemical substance used in laboratory testing, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the reagent is "intended for in vitro diagnostic test".
- Sample Type: It is used to measure creatine kinase activity in "human serum", which is a biological sample taken from the body.
- Purpose: The measurements are used "in the diagnosis and treatment of myocardial infarction and muscle diseases", indicating a medical purpose for the test results.
These are all key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"The Teco Diagnostics Creatine Kinase liquid reagent is intended for in vitro diagnostic test for the quantitative determination of creatine kinase activity in human serum. 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
Prescription Use
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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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Teco Diagnostics c/o Ms. Kelly Chen 1268 N. Lakeview Avenue Anaheim, CA 92807
APR 1 8 2008
K072548 Re:
Trade/Device Name: Creatine Kinase Liquid Reagent (Kinetic Method) Regulation Number: 21 CFR §862.1215 Regulation Name: Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System. Regulatory Class: Class II Product Code: CGS Dated: March 12, 2008 Received: March 14, 2008
Dear Ms. Chen:
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 (QS) 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) 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 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) 276-0490. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. 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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Indication for Use
510 (K) Number (if known): K072548
Device Name: Creatine Kinase Liquid Reagent (Kinetic Method)
Indications for Use: "The Teco Diagnostics Creatine Kinase liquid reagent is intended for in vitro diagnostic test for the quantitative determination of creatine kinase activity in human serum. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. "
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
Division Sign-Off
Office of In Vito Diagnostic Device Evaluation and Sat