(51 days)
Diazyme Liquid Stable Enzymatic Sodium Assay is intended for the quantitative in vitro determination of sodium in serum. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
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The provided text is a 510(k) summary for an in vitro diagnostic device, the "Diazyme Liquid Stable Enzymatic Sodium Assay." It primarily focuses on the regulatory clearance process and does not contain detailed information about the specific studies, acceptance criteria, or performance metrics typically found in a clinical study report. Therefore, I cannot provide the requested information.
The document states that the FDA has determined the device is substantially equivalent to a legally marketed predicate device, indicating that the new device performs as well as, or better than, an existing device for the intended use. However, it does not include the detailed study results to demonstrate this.
To answer your questions, I would need access to the actual study reports or a more detailed technical document submitted with the 510(k) application, which typically contains:
- Acceptance Criteria: Specific thresholds for accuracy, precision, linearity, etc.
- Reported Device Performance: The actual results from the studies that demonstrate how well the device performed against the acceptance criteria.
- Sample Size and Data Provenance: Details about the patient samples used in the studies.
- Ground Truth Establishment: Methods used to determine the true sodium levels for comparison.
- Adjudication Method: If relevant (usually for diagnostic imaging studies).
- MRMC or Standalone Studies: Whether comparative studies with human readers or standalone algorithm performance was evaluated (again, more common for imaging AI).
- Training Set Information: For AI/machine learning devices, details on the training data.
Without this specific clinical performance data, I cannot complete the table or answer the detailed questions about the study design and results.
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.