(55 days)
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No
The summary describes a standard enzymatic assay kit for measuring potassium levels, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is an in vitro diagnostic assay used for the quantitative determination of potassium in serum to monitor fluid and electrolyte balance, not to provide therapy.
Yes
The device is described as an "Assay Kit" intended for "quantitative in vitro determination of potassium in serum." The results are "used to monitor fluid and electrolyte balance," which directly relates to diagnosing or monitoring a patient's health status.
No
The 510(k) summary describes an "Assay Kit" and "Calibrators," which are physical components used for in vitro diagnostic testing. This indicates a hardware-based device, not a software-only one.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is for the "quantitative in vitro determination of potassium in serum." The term "in vitro" (meaning "in glass" or "in the lab") is a key characteristic of IVDs, as they are used to examine samples taken from the body, rather than being used directly on or in the body.
- Sample Type: The assay is designed to measure potassium in "serum," which is a biological sample taken from a patient.
- Purpose: The results are used to "monitor fluid and electrolyte balance," which is a diagnostic purpose.
Therefore, the Diazyme Potassium Enzymatic Assay Kit fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative in vitro determination of Diazyme Potassium Enzymatic Assay Kit. The results obtained by this assay are used to monitor electrolyte balance.
Diazyme Potassium Enzymatic Assay has controls for normal serum potassium level and abnormal serum potassium level. These controls are used as reference samples for checking the functionality of the Diazyme Potassium Enzymatic Assay.
Product codes
MZV
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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§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol, possibly representing a stylized eagle or a human figure, with three curved lines forming the body and wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 5 2006
Mr. Huan Tran Quality Manager Diazyme Laboratories 3550 General Atomics Court San Diego, CA 92121
K053566 Re:
Trade/Device Name: Diazyme Potassium Enzymatic Assay Regulation Number: 21 CFR§862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: MZV Dated: January 18, 2006 Received: January 19, 2006
Dear Mr. Tran:
We have reviewed your Section 510(k) premarket notification of intent to market the device w Charle roview your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of 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) I ms letter will anow you to oegin maneeting your maneering of your device to a legally prematication. "The PDT Intentig sification 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, If you desire specific information as varies of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the v firo Diagnostic Dovieo Branding by reference to premarket notification" (21CFR Part 807.97). Tegulation chilliou, "Miooreneing on your responsibilities under the Act from the Tou may other of Small 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/industry/support/index.html.
Sincerely yours,
Alberto Garcia, Ph.D.
Alberto Gutierrez, Ph.D. 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): K053566
Device Name: Diazyme Potassium Enzymatic Assay Kit
Indications for Use:
Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low
of Diazyme Potassium Enzymanc Assay Nr. In onjantitive in vitro determination of
and High Calibrators, are intended for the abtained by this assay are used to monitor and High Calibrators, are intended for the quantian Film electrolyte balance.
Diazyme Potassium Enzymatic Assay has controls for normal serum potassium ievel
s for Diazyme Potassium Lifzymatic Assay nuo ontrois are used as reference samples for and abnomal Scrum potabolancieren Potassium Enzymatic Assay.
checking the functionality of the Diazyme Potassium Enzymatic Assay.
Carol Benson
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)