(101 days)
The PROLYTE is intended to be a direct replacement for the PROLYTE Electrolyte Analyzer (K070104).
The PROLYTE Electrolyte Analyzer is designed for clinical laboratory use by 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 palients with electrolyte imbalance. These locations routinely conform to CLIA requlations, 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, and chloride in whole blood, plasma, serum, and pre-diluted urine samples.
The PROLYTE Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer. 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 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.
The PROLYTE Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the PROLYTE Electrolyte Analyzer. 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. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
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 pre-diluted urine samples. The 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 ensures that 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 can be programmed to selfcalibrate using Mission Diagnostics 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) 033063) are the recommended quality control material to be used daily.
Here's an analysis of the acceptance criteria and study details for the PROLYTE Electrolyte Analyzer, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the PROLYTE Electrolyte Analyzer are primarily focused on precision (within-run and total imprecision) and linearity. Another critical criterion for this 510(k) submission is substantial equivalence to its predicate device throughout its claimed measuring range, demonstrated through method comparison studies.
Here's the table summarizing these criteria and the reported performance from the provided document:
| Aspect | Analyte & Matrix | Acceptance Criteria (Performance Goal) | Reported Device Performance (Example Values - Note: Actual tables contain more detailed values, representative ones are presented here) | Pass/Fail |
|---|---|---|---|---|
| Precision | ||||
| Within-Run %CV | Serum/Blood: Na+ | ≤ 1% | Whole Blood: 0.60%, 0.58%, 0.91% | |
| Plasma: 0.95%, 0.55%, 0.63% | ||||
| Serum: 0.64%, 0.59%, 0.68% (all P) | Pass | |||
| Within-Run %CV | Serum/Blood: K+ | ≤ 2% | Whole Blood: 0.79%, 0.78%, 1.20% | |
| Plasma: 1.50%, 0.85%, 0.46% | ||||
| Serum: 0.66%, 0.70%, 0.85% (all P) | Pass | |||
| Within-Run %CV | Serum/Blood: Cl- | ≤ 2% | Whole Blood: 0.80%, 0.64%, 0.72% | |
| Plasma: 0.75%, 0.57%, 0.47% | ||||
| Serum: 1.47%, 0.67%, 1.25% (all P) | Pass | |||
| Within-Run %CV | Urine (1:10 dilution): Na+ | ≤ 2.5% | Urine: 0.54%, 0.68%, 0.55% (all P) | Pass |
| Within-Run %CV | Urine (1:10 dilution): K+ | ≤ 2.5% | Urine: 0.91%, 0.49%, 0.84% (all P) | Pass |
| Within-Run %CV | Urine (1:10 dilution): Cl- | ≤ 2.5% | Urine: 1.72%, 0.62%, 0.56% (all P) | Pass |
| Total %CV | Serum/Blood: Na+ | ≤ 2% | Whole Blood: 0.93%, 0.72%, 0.85% | |
| Plasma: 0.71%, 0.70%, 0.59% | ||||
| Serum: 0.76%, 0.88%, 1.03% (all P) | Pass | |||
| Total %CV | Serum/Blood: K+ | ≤ 2.5% | Whole Blood: 1.23%, 0.59%, 2.15% | |
| Plasma: 1.73%, 1.25%, 1.48% | ||||
| Serum: 0.91%, 0.80%, 1.19% (all P) | Pass | |||
| Total %CV | Serum/Blood: Cl- | ≤ 2.5% | Whole Blood: 1.30%, 1.13%, 1.09% | |
| Plasma: 1.25%, 0.83%, 0.81% | ||||
| Serum: 1.80%, 0.83%, 0.87% (all P) | Pass | |||
| Total %CV | Urine (1:10 dilution): Na+ | ≤ 5% | Urine: 3.82%, 1.02%, 1.48% (all P) | Pass |
| Total %CV | Urine (1:10 dilution): K+ | ≤ 5% | Urine: 1.57%, 1.06%, 0.91% (all P) | Pass |
| Total %CV | Urine (1:10 dilution): Cl- | ≤ 5% | Urine: 2.53%, 1.69%, 1.76% (all P) | Pass |
| Linearity | Na+, K+, Cl- across all matrices | R² > ~0.99 (Implicit in strong linear fit required for medical devices) | R² values for all analytes and matrices are very high, ranging from 0.9965 to 0.9997. (All P) | Pass |
| Method Comparison | Na+, K+, Cl- across all matrices | Strong correlation (R² > ~0.98) and slope near 1, intercept near 0, when compared to predicate device within reportable range to demonstrate substantial equivalence. | All R² values are between 0.9844 and 0.9995. Slopes are close to 1, and intercepts are close to 0, indicating strong agreement with the predicate. (All P) | Pass |
2. Sample Size and Data Provenance for the Test Set
- Precision Test Set Sample Sizes:
- Within-Run Imprecision: 30 replicates for each sample (low, mid, high concentrations) per analyte and matrix.
- Total Imprecision: 40 replicates (2 measurements daily for 10 days for serum, plasma, urine; 40 replicates on 2 instruments for whole blood).
- Linearity Test Set Sample Sizes:
- Whole Blood: 42 (Na+), 36 (K+), 42 (Cl-)
- Plasma: 42 (Na+), 54 (K+), 42 (Cl-)
- Serum: 33 (Na+), 33 (K+), 27 (Cl-)
- Urine: 40 (Na+), 36 (K+), 34 (Cl-)
- Method Comparison Test Set Sample Sizes:
- Whole Blood: 110 (Na+), 111 (K+), 108 (Cl-)
- Plasma: 101 (Na+), 104 (K+), 101 (Cl-)
- Serum: 103 (Na+), 100 (K+), 106 (Cl-)
- Urine: 102 (Na+), 105 (K+), 101 (Cl-)
- Data Provenance: The document does not specify the country of origin. It indicates that these are "non-clinical tests" and "clinical tests" referring to method comparisons with patient samples. The samples were either patient samples or spiked/diluted samples to cover the entire measuring range. This implies a prospective collection and testing approach for portions of the method comparison and possibly for precision and linearity.
3. Number of Experts and Qualifications for Ground Truth
- This device is an in vitro diagnostic (IVD) device (analyzing chemical analytes in body fluids) for which the "ground truth" is typically established by reference methods, calibrated standards, or a predicate device, not by human expert interpretation like in imaging.
- For the method comparison studies, the predicate device (original PROLYTE Electrolyte Analyzer K070104) served as the reference for ground truth. Therefore, the "experts" in this context would be the predicate device itself, which has been previously cleared by the FDA based on its own validation.
4. Adjudication Method for the Test Set
- No adjudication method (like 2+1 or 3+1 consensus) is applicable or mentioned. As an IVD device, measurements are quantitative and compared directly to either itself (for precision and linearity) or a predicate device (for method comparison), not to subjective expert interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done or is applicable. This is an IVD device providing quantitative measurements, not an AI imaging or diagnostic algorithm that assists human readers.
6. Standalone Algorithm Performance
- Yes, the entire study focuses on standalone performance of the PROLYTE Electrolyte Analyzer. The "algorithm" here refers to the instrument's internal measurement and processing capabilities. The non-clinical (precision and linearity) and clinical (method comparison) tests assess the device's inherent performance characteristics directly.
7. Type of Ground Truth Used
- For precision and linearity, the ground truth is established by the known concentrations of the analytes in the control materials and diluted stock solutions. These are internal reference points.
- For method comparison, the ground truth is established by the measurements obtained from the predicate device (original PROLYTE Electrolyte Analyzer K070104). This approach aims to demonstrate substantial equivalence, meaning the new device performs comparably to a device already cleared for market.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" in the context of machine learning. The device is an analyzer that uses ion-selective electrodes, and its "software" was rewritten, but its underlying measurement principles are the same as the predicate. The performance studies described are for validation/testing of the implemented system, not for training a model in the machine learning sense. The device is likely calibrated using standardized solutions, which could be considered an ongoing "training" or calibration process, but this is distinct from a one-time dataset for algorithm development.
9. How the Ground Truth for the Training Set Was Established
- As noted above, the concept of a training set as typically understood in machine learning is not directly applicable here. The device functions based on established electrochemical principles. The "calibration" of the device likely uses certified reference materials with known concentrations, ensuring accuracy. This would be part of the device's operational procedure rather than a study-specific training set.
§ 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.