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510(k) Data Aggregation
(212 days)
The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples.
The SmartLyte® Plus Sodium Assay is intended to measure sodium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus 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 SmartLyte® Plus Potassum Assay is intended to measure potassium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus 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 SmartLyte® Plus Chloride Assay is intended to measure the level of chloride in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The SmartLyte® Plus Lithium Assay is intended to measure lithium carbonate) in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Measurements of ithium are used to assure that the proper drug dosage is administered in the treatment with mental disturbances, such as manic-depressive illness (bipolar disorder).
For in-vitro diagnostic use only.
The SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which can test Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials is substantially equivalent to it's predicate SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of Sodium, Potassium, Chloride, Calcium and Lithium in Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours throughout the day or on request. Sodium. Potassium. Chloride and Calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended quality control material to be used daily.
The SmartLyte® Plus is intended to be a direct replacement for the SmartLyte® Electrolyte Analyzer (K082462).
The SmartLyte® Plus Electrolyte Analyzer is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride, Calcium and Lithium found in Venous Whole Blood, Sodium Heparin Plasma, Serum, 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.
The document describes the performance of the SmartLyte® Plus Electrolyte Analyzer. This device is an in-vitro diagnostic instrument, and the provided information details its analytical performance characteristics rather than the performance of an AI algorithm with human readers or a medical imaging device. Therefore, many of the requested points related to AI, MRMC studies, human experts, and ground truth establishment for complex data like images are not directly applicable or available in this document.
However, I can extract and present the acceptance criteria and reported device performance for the SmartLyte® Plus Electrolyte Analyzer as it relates to its analytical accuracy and precision.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The document presents performance data for Precision and Linearity for each analyte (Na+, K+, Cl-, Ca++, Li+) across different sample types (Serum, Plasma, Whole Blood, Urine). The acceptance criteria are implicitly quantitative, as the 'Status' for each test is reported as "Pass" against numerical criteria.
1. Table of Acceptance Criteria and Reported Device Performance (Summary)
Since the document provides extensive tables for precision (within-run and run-to-run) and linearity for each analyte and matrix, I will summarize the general acceptance criteria and indicate that the device passed all these criteria as reported in the document. Presenting every single data point for all analytes and matrices would be too large for this format.
Precision (for Serum/Blood/Plasma)
| Analyte | Within Run Criterion (CV or SD) | Between Run Criterion (CV or SD) | Device Performance (Status) |
|---|---|---|---|
| Na+ | CV ≤ 1% | CV ≤ 2% | Pass |
| K+ | CV ≤ 1.5% | CV ≤ 3% | Pass |
| Cl- | CV ≤ 1% | CV ≤ 3% | Pass |
| Ca++ | SD ≤ 0.02 | SD ≤ 0.06 | Pass |
| Li+ | SD ≤ 0.03 | SD ≤ 0.09 | Pass |
Precision (for Urine)
| Analyte | Within Run Criterion (CV) | Between Run Criterion (CV) | Device Performance (Status) |
|---|---|---|---|
| Na+ | CV ≤ 5% | CV ≤ 5% | Pass |
| K+ | CV ≤ 5% | CV ≤ 5% | Pass |
| Cl- | CV ≤ 5% | CV ≤ 5% | Pass |
Linearity (General Acceptance Criterion)
| Performance Metric | Implicit Acceptance Criteria | Device Performance (Status) |
|---|---|---|
| Slope | Near 1.0 (actual ranges provided in tables are typically 0.97 to 1.03) | Achieved (Values reported) |
| Intercept | Near 0.0 (actual values reported) | Achieved (Values reported) |
| R² (Coefficient of Determination) | High value, typically > 0.99 (actual values reported are 0.9939 to 0.9997, indicating strong linear correlation) | Achieved (Values reported) |
| Reportable Range | The linearity studies supported the claimed measurement ranges for each analyte and matrix. | Supported |
Detection Limit
| Analyte | Acceptance Criteria for %TE | Claimed Measurement Range | Device Performance (%TE) | Device Performance (Status) |
|---|---|---|---|---|
| Ca++ | 21.6% | 0.3 - 5.0 mmol/L | 5.541% - 11.868% | Pass (LoQ < Range min) |
| Li+ | 21.6% | 0.2 - 6.0 mmol/L / 0.2-5.5 mmol/L | 6.208% - 14.085% | Pass (LoQ < Range min) |
Method Comparison (General Acceptance Criterion)
The criteria for method comparison are implicitly that the SmartLyte® Plus shows a "good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.97 and 1.03."
The documented R² values are all greater than 0.99 (ranging from 0.9939 to 0.9987), and slope values are indeed within 0.97 and 1.03.
Study that Proves the Device Meets Acceptance Criteria:
The document describes several non-clinical and clinical tests performed to demonstrate that the SmartLyte® Plus Electrolyte Analyzer meets its performance claims and is substantially equivalent to its predicate device (SmartLyte® K082462).
2. Sample Size and Data Provenance:
- Precision Test Set Sample Sizes:
- Within Run: 30 replicates (n=30) for each sample type (Serum, Plasma, Whole Blood, Urine) and analyte.
- Between Run/Total Precision:
- Serum/Plasma/Urine: Duplicate measurements over 20 days (total of 40 replicates).
- Venous Whole Blood: 20 samples from 2 instruments over a 2-hour period (total of 40 replicates).
- Linearity Test Set Sample Sizes (n):
- Serum: Sodium (48), Potassium (75), Chloride (45), Calcium (72), Lithium (70)
- Plasma: Sodium (75), Potassium (75), Chloride (39), Calcium (42), Lithium (42)
- Whole Blood: Sodium (54), Potassium (69), Chloride (42), Calcium (52), Lithium (39)
- Urine: Sodium (19), Potassium (19), Chloride (19)
- Method Comparison Test Set Sample Sizes (n):
- Serum: 109-125 samples per analyte
- Plasma: 110-125 samples per analyte
- Whole Blood: 108-112 samples per analyte
- Urine: 115-118 samples per analyte
- Data Provenance: The document does not specify the country of origin of the data. It indicates that samples were collected for testing. The nature of the study (analytical performance of a medical device) typically implies controlled laboratory conditions rather than broad population-based data. The studies are described as "non-clinical" and "clinical tests," but the "clinical" aspect refers to using human biological samples for analytical validation in a lab setting, not a direct patient outcome study. The studies appear to be prospective, designed specifically for this 510(k) submission.
3. Number of Experts and Qualifications: Not applicable. This is an analytical performance study of an in-vitro diagnostic device, not an image-based AI study requiring expert readers for ground truth establishment. The performance is assessed against quantitative measurements and statistical methods (CLSI guidelines).
4. Adjudication Method: Not applicable. (See #3)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No, not applicable. This is not an AI-assisted diagnostic imaging device study. The device functions as a standalone analyzer that measures electrolyte concentrations. Its "comparison" is against a predicate device (another equivalent analyzer), not human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone analyzer. Its performance is measured as output values (mmol/L) directly from the instrument. The 'algorithm' here refers to the internal software and hardware that processes the ion-selective electrode signals to produce the final measurement. The performance data presented (precision, linearity, detection limit, method comparison) are the standalone performance of the device.
7. The type of ground truth used:
- For Precision, Linearity, and Detection Limit: The "ground truth" or reference for these studies refers to the accurate measurement of known concentrations in control materials or diluted stock solutions (for linearity), and statistical evaluation of repeatability. For detection limit, reference to a "reference analyzer (Flame Photometer SN 86011421)" is made for target values.
- For Method Comparison: The "ground truth" for the method comparison study was established by comparing the results of the SmartLyte® Plus Analyzer to those obtained from the predicate device, SmartLyte® (K082462), implying the predicate device serves as the established reference for comparison.
8. The Sample Size for the Training Set: Not applicable in the context of typical AI/ML model training. This is an analytical instrument, not a learning algorithm that requires a separate "training set" of data in the AI sense. The development of the device's measurement principles and internal parameters would rely on established chemical and engineering principles and internal validation.
9. How the ground truth for the training set was established: Not applicable for the reasons stated in #8. The device's "training" is its design, calibration, and validation processes based on quantitative chemical and electrical measurement principles, not from a data-driven learning approach. Calibration standards traceable to NIST (National Institute of Standards and Technology) are used for the actual device calibration.
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(163 days)
The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in whole blood, plasma and serum, and prediluted urine samples.
The GemLyte Potassium Assay is intended to measure potassium in whole blood, plasma, serum, and urine on the GemLyte 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 GemLyte Sodium Assay is intended to measure sodium in whole blood, plasma, serum, and urine on the GemLyte 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 GemLyte 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.
The GemLyte Calcium Assay is intended to measure the ionized calcium level in whole blood, plasma and serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The GemLyte Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma and serum. 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).
The GemLyte is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood and prediluted urine samples. GemLyte 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, (less than a minute for samples), but also that the testing of samples can be done by even non-skilled operators with relative ease. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended quality control material to be used daily.
The provided text describes the 510(k) summary for the GemLyte Electrolyte Analyzer. Here's a breakdown of the acceptance criteria and the study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GemLyte Electrolyte Analyzer are primarily based on achieving performance similar to or within specified limits of the predicate device (AVL 9180 (K961458)) and meeting internal reproducibility guidelines. The reported device performance metrics are presented as "reproducibility" (precision) and "correlation" (agreement with predicate device).
Acceptance Criteria (Performance Specifications)
| Metric | Parameter | Matrix | Acceptance Criteria (Internal/Predicate Comparison) | Reported Device Performance (Achieved) |
|---|---|---|---|---|
| Reproducibility (Precision) | ||||
| Within-Run | Na+ | Blood/Plasma/Serum | C.V. ≤1% | C.V. ≤0.6% |
| K+ | Blood/Plasma/Serum | C.V. ≤1.5% | C.V. ≤1.5% | |
| Cl- | Blood/Plasma/Serum | C.V. ≤2% | C.V. ≤1% | |
| Ca++ | Blood/Plasma/Serum | SD ≤0.02 | SD ≤0.02 | |
| Li+ | Blood/Plasma/Serum | SD ≤0.03 | SD ≤0.04 (Note: This is slightly higher than the specified SD ≤0.03 in the "Reproducibility" table but within the "Summary of nonclinical tests" table. The text states "Results are within performance specifications.") | |
| Na+ | Urine | C.V. ≤5% | C.V. ≤ 5% | |
| K+ | Urine | C.V. ≤5% | C.V. ≤ 5% | |
| Cl- | Urine | C.V. ≤5% | C.V. ≤ 2% (Note: This is better than the specified C.V. ≤ 5% in the "Reproducibility" table but within the "Summary of nonclinical tests" table. The text states "Results are within performance specifications.") | |
| Between-Run | Na+ | Serum/Blood/Serum | C.V. ≤2% | C.V. ≤1.5% |
| K+ | Serum/Blood/Serum | C.V. ≤3% | C.V. ≤3% | |
| Cl- | Serum/Blood/Serum | C.V. ≤3% | C.V. ≤3% | |
| Ca++ | Serum/Blood/Serum | SD ≤0.06 | SD ≤0.06 | |
| Li+ | Serum/Blood/Serum | SD ≤0.09 | SD ≤0.09 | |
| Na+ | Urine | C.V. ≤5% | C.V. ≤4% | |
| K+ | Urine | C.V. ≤5% | C.V. ≤5% | |
| Cl- | Urine | C.V. ≤5% | C.V. ≤3% | |
| Linearity | All | All claimed range | Correlation coefficients > 0.99 (regression analysis) | All correlation coefficients were greater than 0.99. |
| Correlation to Predicate Device | All | All sample types | Correlation coefficients > 0.99 (regression analysis) | "Regression analysis show good correlation to predicate devices for all sample types, whole blood, plasma, serum and urine with correlation coefficients typically greater than 0.99." Specific R² values are provided in the tables above, all of which are ≥0.9687 (Chloride in Serum). |
2. Sample Size Used for the Test Set and Data Provenance
The test set for the correlation studies used the following sample sizes:
- Whole Blood: Sodium (n=128), Potassium (n=112), Chloride (n=123), Calcium (n=124), Lithium (n=123)
- Plasma: Sodium (n=105), Potassium (n=107), Chloride (n=115), Calcium (n=123), Lithium (n=115)
- Serum: Sodium (n=122), Potassium (n=127), Chloride (n=125), Calcium (n=120), Lithium (n=131)
- Urine (Spot): Sodium (n=118), Potassium (n=108), Chloride (n=118)
Data Provenance: The document does not explicitly state the country of origin. It indicates that samples were "collected for testing on the GemLyte as well as another predicate device, the AVL 9180." The language used (e.g., "mmol/L") is standard for clinical chemistry. The study appears to be prospective in nature, as it describes a setup for collecting and testing samples on two devices for comparison.
For precision (reproducibility) studies:
- Within-Run: 30 replicates for each sample type (blood, serum, urine).
- Between-Run: 2 runs per day with 2 replicates per run for 10 days for each sample type.
- Potassium (Whole Blood Specific): Multiple instruments (4) tested over a period of an hour due to instability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (electrolyte analyzer) does not typically rely on "expert" interpretation for ground truth, unlike imaging or diagnostic AI. The "ground truth" for the correlation study is the measurement obtained from the predicate device (AVL 9180), which is an established, legally marketed device for the same purpose. The text states, "Clinical testing was conducted to demonstrate the correlation of Diagnostics GemLyte Analyzer to predicate devices operated by trained personnel." It clarifies that the comparison device was operated by "trained personnel," implying standard laboratory practice, but does not specify "experts" in the sense of clinical specialists like radiologists.
4. Adjudication Method for the Test Set
Not applicable. As explained above, the ground truth is established by the predicate device's readings, not by expert consensus or adjudication. The study design is a direct comparison of measurements between two devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an imaging or diagnostic AI device that involves human readers interpreting cases. It is an automated electrolyte analyzer.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies presented are standalone performance evaluations for the GemLyte Electrolyte Analyzer. The device is an automated system; its performance is measured directly (e.g., reproducibility, linearity) and compared against a predicate device's measurements, not against human performance in a diagnostic reading task.
7. Type of Ground Truth Used
The ground truth for the clinical correlation studies was the measurements obtained from the predicate device, AVL 9180. For within-run precision, the ground truth is implicitly the true stable concentration within the sample, with the device aiming to measure it consistently. For linearity, the ground truth was prepared standard solutions (dilutions from starting stock solutions).
8. Sample Size for the Training Set
The document does not specify a separate "training set" in the context of an AI/ML model for this device. The GemLyte Electrolyte Analyzer is based on ion-selective electrode (ISE) technology, not machine learning. Therefore, it does not typically involve a "training set" in the computational sense. The device is calibrated using internal calibration solutions and Diamond Diagnostics Fluid Pack (510(k) 013850) as described in the calibration section.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI/ML model, this question is not applicable in the typical sense.
For the device's internal calibration, the "ground truth" would be the known concentrations of the calibration solutions, which are presumably traceable to established standards. The text states:
- "The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request."
- "The GemLyte performs a 2-point calibration (3-point calibration if lithium) every 4 hours or software permits calibration on demand. A 1-point calibration is performed automatically with each measurement."
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