(88 days)
For in vitro quantitative determination of potassium in human serum. 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. For IVD use only.
Calibrator:
The Diazyme Liquid Stable Enzymatic Potassium Assay Calibrator Kit is intended for use in the calibration of quantitative Diazyme Liquid Stable Enzymatic Potassium Assay Kit (DZ113C). For IVD use only.
Controls:
The Diazyme Liquid Stable Enzymatic Potassium Assay Control Kit is intended for use as quality controls for the Diazyme Liquid Stable Enzymatic Potassium Assay (DZ113C). For IVD use only.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Diazyme Liquid Stable Enzymatic Potassium Assay Kit". This document primarily focuses on the regulatory approval process and does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance.
Therefore, I cannot provide the requested information. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Information about MRMC comparative effectiveness studies or human reader improvement with AI.
- Details on standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval, not a scientific study report. To find the information you're looking for, you would typically need to consult a detailed clinical validation report or a scientific publication related to this specific device.
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Public Health Service
Diazyme Laboratories c/o Dr. Abhijit Datta Director, Technical Operations 12889 Gregg Court Poway, CA 92064
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
AUG 1 4 2009
Re: K091455
Trade Name: Diazyme Liquid Stable Enzymatic Potassium Assay Kit, Diazyme Liquid Stable Enzymatic Potassium Assay Calibrator Kit, Diazyme Liquid Stable Enzymatic Potassium Assay Controls
Regulation Number: 21 CFR §862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Codes: MZV, JIT, JJX Dated: May 05, 2009 Received: May 18, 2009
Dear Dr. Abhijit Datta:
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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H.
Courtney C. Harper, Ph.D. 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: K091455
Device Name: Diazyme Liquid Stable Enzymatic Potassium Assay Kit
Indications for Use:
For in vitro quantitative determination of potassium in human serum. 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. For IVD use only.
Calibrator:
The Diazyme Liquid Stable Enzymatic Potassium Assay Calibrator Kit is intended for use in the calibration of quantitative Diazyme Liquid Stable Enzymatic Potassium Assay Kit (DZ113C). For IVD use only.
Controls:
The Diazyme Liquid Stable Enzymatic Potassium Assay Control Kit is intended for use as quality controls for the Diazyme Liquid Stable Enzymatic Potassium Assay (DZ113C). For IVD use only.
Prescription X Use (Part 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 Vitro Diagnostic Evaluation and Safety
10(k) K091455
§ 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.