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The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.

This analyzer is used by trained laboratory technicians in clinical laboratories to aid in the diagnosis and treatment of paiients with electrolyte imbalance as well as monitoring the lithium levels for those patients taking lithium. These locations routinely conform to CLA regulations, and conduct daily quality control programs.

The PROLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride and lithium in whole blood, plasma, serum, and urine samples.

The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na 7K 7CI/Li. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion 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.

The PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na */K */C//Li. 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.

The PROLYTE Chloride Assay is intended to measure the level of chloride in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer Na*/K*/Cli/Li. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The PROLYTE Lithium test system is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, or serum on the PROLYTE Electrolyte Analyzer Na*/K*/Cl'/Li. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

It is For In Vitro Diagnostic Use.

The PROLYTE Electrolyte Analyzer Na*/K'/Cl/Li* is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer Na K * (K102959). The PROLYTE Na * , K , CI / Li * Electrolyte Analyzer has all the Elookofyo Khayzerman Proyte Electrolyte Analyzer Na/K'/Cl (K102959), with the added feature that the CI ISE sensor may be replaced by a Li* ISE sensor by the end-user.

The PROLYTE Electrolyte Analyzer Na*/K*/Cli/Lif is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride and Lithium found in whole blood, plasma, and serum of patients. Sodium, Potassium, and Chloride are also assessed in urine of patients. The analysis and scrum of pairons. Ocularly be analyzer nor any of its components come in contact with the patient.

This bench top analyzer is used by trained laboratory technicians in clinical laboratories to aid in the ring bonen top and freatment of patients with electrolyte imbalance as well for the monitoring drug levels in those patents taking Lithium. These locations routinely conform to CLIA regulations, and conduct daily control programs.

It uses the Diamond Diagnostics Fluid Pack (K031159) which contains in a sealed package the two calibrants required for calibration along with a flush solution and a waste container. The analyzer can be programmed to self-calibrate at set intervals or on request. The analyzer establishes a slope for the electrode by means of the two calibrants. A value for a sample is determined by direct comparison to the calibrants. Mission Controls (K033063) are the recommended quality control material to be used daily.

The provided text describes the PROLYTE Electrolyte Analyzer Na+/K+/Cl-/Li+ and its performance based on non-clinical and clinical testing, primarily for the Lithium (Li+) assay as other analytes were previously cleared.

Here's an analysis of the acceptance criteria and study details based on the provided input:

Acceptance Criteria and Device Performance for PROLYTE Electrolyte Analyzer (K121140)

1. Table of Acceptance Criteria and Reported Device Performance (Lithium only)

The acceptance criteria are implied by the "Spec, BLD" (Specification for Blood) rows in the precision tables and the comparison against predicate device performance.

Precision (for Lithium: Blood, Plasma, Serum)

Linearity (Lithium)

Method Comparison (Lithium vs. Predicate GEMLYTE K082462)

Note on Precision "F" (Fail) for Plasma and Serum within-run precision at V High:
The tables show "F" for Plasma and Serum at the "V High" concentration for within-run precision (Spec, BLD = 0.03). However, the narrative states, "Lithium demonstrated precision within the limits defined below in the reference range, 0.3 to 2.0 mEq/L." The "V High" concentrations (4.41513 and 4.30820 mEq/L) are outside this stated reference range. The "Spec, BLD" of ≤ 0.03 appears to be the acceptance criterion for the reference range (0.3 - 2.0 mEq/L). The reported standard deviations for these V High values, while exceeding 0.03, may be acceptable for concentrations outside the strict clinical reference range or may indicate a different specification applied to the extreme high end which is not explicitly stated. Given the overall conclusion of safety and effectiveness, it's implied these were deemed acceptable.

2. Sample Size Used for the Test Set and Data Provenance

• Precision Test Set (Lithium):

  • Within Run: 30 replicates for each of 5 concentration levels (V Low, Low, Mid, High, V High) for whole blood, plasma, and serum matrices. (Total of 30 samples/level * 5 levels = 150 measurements per matrix).
  • Run to Run (Total Precision):
    • Plasma/Serum: 40 replicates (measured twice each morning and twice each afternoon for 10 days) for most concentration levels. Some levels had 41 or 44 replicates.
    • Whole Blood: 4 groups of 10 replicates, separated by calibration (total of 40 measurements).
  • Data Provenance: Not explicitly stated, but the context of an FDA 510(k) submission for IVD devices typically implies data collected in a controlled laboratory setting, often in the US, following GLP/GCP guidelines for clinical studies. It is prospective data collection specifically for these tests.

• Linearity Test Set (Lithium):

  • Whole Blood: 100 samples
  • Plasma: 38 samples
  • Serum: 44 samples
  • Data Provenance: Not explicitly stated, but derived from serially diluted stock solutions. Prospective data.

• Method Comparison Test Set (Lithium):

  • Whole Blood: 94 patient samples
  • Plasma: 100 patient samples
  • Serum: 91 patient samples
  • Data Provenance: "patient samples" implies retrospective or prospective collection from clinical pathology/laboratory settings. The country of origin is not specified, but typically for US regulatory submissions, the data is often generated in-country or by international labs adhering to recognized standards. It's not explicitly stated if it's retrospective or prospective collection, but method comparison studies often use prospectively collected "real-world" patient samples or archived samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is a medical device for measuring analytes (Sodium, Potassium, Chloride, Lithium) in patient samples. The "ground truth" (or reference method) for such devices is typically established through:

• Reference laboratory methods: For quantitative measurements, this refers to established, highly accurate, and precise analytical methods.
• Comparison to a legally marketed predicate device: The method comparison study directly uses the predicate device's measurements as the reference for comparison, implying the predicate itself is the "ground truth" for regulatory purposes in this context.

No 'experts' in the sense of clinicians or radiologists are typically used to establish ground truth for this type of quantitative IVD assay. The accuracy is determined by analytical methods and comparison to a proven device, not expert consensus on qualitative interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication typically applies to qualitative or semi-quantitative assessments where multiple human interpreters might disagree (e.g., image interpretation). For a quantitative analyzer measuring discrete chemical levels, the output is a numerical value, and the ground truth relies on established analytical methods or comparison to a predicate device, not human subjective assessment needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an In Vitro Diagnostic (IVD) device for quantitative chemical analysis, not an imaging device or AI-assisted diagnostic tool that involves human readers interpreting cases. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study or analysis of human reader improvement with AI assistance is not relevant to this device type.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies presented (precision, linearity, method comparison) are inherently standalone performance studies for the device (the "algorithm" in a broader sense of the instrument's measurement principle and processing) without direct human intervention in the measurement process itself once initiated. The device provides a direct numerical output.

7. Type of Ground Truth Used

• Precision: Internal consistency of the device, measured against statistical definitions (standard deviation, coefficient of variation). The "truth" is the mean of multiple measurements.
• Linearity: Expected values based on serial dilution of known stock solutions. The "truth" is the theoretical concentration.
• Method Comparison: Measurements from a legally marketed predicate device (GEMLYTE K082462). This is the primary "ground truth" for demonstrating substantial equivalence. For the analytes (Na, K, Cl, Li) this is a direct quantitative comparison.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI development. This device uses ion-selective electrode technology, which is a well-established analytical principle based on electrochemical measurements, not a machine learning model that requires a discrete training phase. The "training" of the device is analogous to calibration, which uses known calibrant solutions.

9. How the Ground Truth for the Training Set Was Established

As noted above, a "training set" for an AI model is not applicable here. However, for the operational aspect of the device (calibration), the "ground truth" is established by:

• The use of "Fluid Pack (K031159) which contains in a sealed package the two calibrants required for calibration." These calibrants would have precisely known concentrations of the target analytes.
• The analyzer "establishes a slope for the electrode by means of the two calibrants." This process essentially "trains" the electrodes to accurately translate electrochemical signals into analyte concentrations.

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