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K Number
K091455
Device Name
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
Manufacturer
DIAZYME LABORATORIES
Date Cleared
2009-08-14

(88 days)

Product Code
MZV,JIT,JJX
Regulation Number
862.1600
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

Not Found

AI/ML Overview

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:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for test sets or data provenance.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication methods.
  5. Information about MRMC comparative effectiveness studies or human reader improvement with AI.
  6. Details on standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. 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.

§ 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.