(483 days)
The proLYTE Electrolyte Analyzer is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, and Chloride 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 laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte imbalance. These locations routinely conform to CLIA regulations, and conduct daily quality control programs.
For In Vitro Diagnostic Use
The proLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium and chloride in serum, plasma, whole blood and prediluted urine samples, proLYTE analyzer is designed with the user in mind, it is fully automated with simple 'Yes' or 'No' commands for menu navigation. This simple interface insures that not only will the analyzer be easy to use for quick analysis, (one minute for most samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer an be programmed to self-calibrate using Mission Diagnostics ILyte 800 Fluid Pack Na/K/Cl (510(k) 031159) at set intervals or on request. Sodium, potassium and chloride are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Mission Controls (510(k) J33063) are the recommended quality control material to be used daily.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the proLYTE Electrolyte Analyzer:
1. Table of Acceptance Criteria and Reported Device Performance:
| Analyte | Sample Type | Acceptance Criteria (Within-Run Precision) | Reported Device Performance (Within-Run Precision) | Acceptance Criteria (Between-Run Precision) | Reported Device Performance (Between-Run Precision) | Linearity (Correlation Coefficient) |
|---|---|---|---|---|---|---|
| Na+ | Serum/Blood | C.V. ≤ 1% | "within performance specifications" | C.V. ≤ 2% | "within performance specifications" | > 0.99 |
| K+ | Serum/Blood | C.V. ≤ 2% | "within performance specifications" | C.V. ≤ 2.5% | "within performance specifications" | > 0.99 |
| Cl- | Serum/Blood | C.V. ≤ 2% | "within performance specifications" | C.V. ≤ 2.5% | "within performance specifications" | > 0.99 |
| Na+ | Urine (1:10 dil.) | C.V. ≤ 2.5% | "within performance specifications" | C.V. ≤ 2.5% | "within performance specifications" | > 0.99 |
| K+ | Urine (1:10 dil.) | C.V. ≤ 2.5% | "within performance specifications" | C.V. ≤ 2.5% | "within performance specifications" | > 0.99 |
| Cl- | Urine (1:10 dil.) | C.V. ≤ 2.5% | "within performance specifications" | C.V. ≤ 5% | "within performance specifications" | > 0.99 |
Note: The reported performance for precision states "within performance specifications." This indicates that the measured CV values were equal to or less than the specified acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Precision (within-run): Minimum of 30 replicates for each sample type (blood, serum, urine).
- Precision (between-run): 2 runs per day (AM & PM) with 2 replicates per run for 10 days for each sample type. This equates to 40 measurements per sample type (2 runs/day * 2 replicates/run * 10 days).
- Linearity: Minimum of 5 levels tested for each sample type.
- Clinical Testing (Correlation to Predicate Device): Not explicitly stated, but "All sample types, whole blood, plasma, serum and urine were collected for testing." The exact number of samples is not provided in this summary.
- Data Provenance: Not explicitly stated. The document doesn't mention the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for an in-vitro diagnostic, it's highly likely to be prospective data collected specifically for validation, but this isn't confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- None specified. For an electrolyte analyzer measuring quantitative values, the ground truth is typically established by reference methods or predicate devices, not by expert consensus in the same way an image analysis algorithm might use radiologists. The "ground truth" in this context is the actual concentration of the analytes as determined by a highly accurate and precise method. The clinical testing portion compares the proLYTE analyzer to "predicate devices operated by trained personnel," implying the predicate device serves as the reference for comparison.
4. Adjudication Method for the Test Set:
- Not applicable. As the device measures quantitative chemical analytes, there is no "adjudication" in the traditional sense of human readers disagreeing on an interpretation. The comparison is statistical (regression analysis) against reference measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study is typically for evaluating the diagnostic performance of human readers (e.g., radiologists) with and without AI assistance on a set of cases. This device is a quantitative analytical instrument, not an AI-assisted diagnostic tool for human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, this is a standalone device. The proLYTE Electrolyte Analyzer is an automated instrument that performs measurements directly. Its performance summarized in the document (precision, linearity, correlation) represents its standalone capability without human interpretation being part of the measurement process itself. Human operators introduce the sample and initiate the analysis, but the measurement and result generation are entirely automated.
7. The Type of Ground Truth Used:
- Reference measurements from predicate devices and/or highly accurate laboratory methods. For precision and linearity studies, the ground truth is often established by making known dilutions or using control materials with certified values. For clinical correlation, the ground truth is established by the measurements obtained from legally marketed predicate devices, which are assumed to be accurate and reliable. The summary states: "Clinical testing was conducted to demonstrate the correlation of Diamond Diagnostics proLYTE Analyzer to predicate devices operated by trained personnel."
8. The Sample Size for the Training Set:
- Not applicable. The proLYTE Electrolyte Analyzer is an electrochemical instrument based on ion-selective electrodes, not a machine learning or AI-driven system that requires a "training set" in the computational sense. Its "training" is inherent in its design, calibration, and manufacturing processes, not in learning from a dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no "training set" for this type of device. The accuracy and calibration are based on established scientific principles of electrochemistry and the use of known calibrant solutions.
§ 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.