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510(k) Data Aggregation
(71 days)
CARESIDE LYTESTM For in vitro diagnostic use with the CARESIDE Analyzer™ to measure sodium, potassium and chloride ion concentrations using anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with electrolyte imbalance.
CARESIDE Analyzer™ For in vitro diagnostic use by laboratory professionals. Used in conjunction with reagent cartridges to duplicate manual analytical procedures in order to measure a variety of analytes.
The CARESIDE LYTES™, a single-use disposable in vitro diagnostic test cartridge, is used with the CARESIDE Analyzer™ to perform a simultaneous quantitative measurement of sodium, potassium and chloride ion concentrations from a single sample of anti-coagulated whole blood, plasma or serum. Each cartridge has a test element containing sodium-, potassium-, and chloride-selective electrodes. The CARESIDE LYTESTM test cartridge aids in specimen separation and delivers a measured volume of plasma or serum to the electrochemistry to initiate the measurement of sodium, potassium and chloride ion concentrations. The cartridge (patent pending) contains all reagents necessary to measure the concentration of sodium, potassium and chloride ions.
Here's a summary of the acceptance criteria and study findings for the CARESIDE LYTES™ device, based on the provided document:
CARESIDE LYTES™ Device Performance and Acceptance Criteria
The CARESIDE LYTES™ device, used with the CARESIDE Analyzer™, measures sodium, potassium, and chloride ion concentrations. The acceptance criteria are largely implied by the comparative performance characteristics against a legally marketed predicate device (Vitros Na+, K+, Cl- DT Slides and Vitros DT 60 II / DTE II). The study demonstrates that the CARESIDE LYTES™ performs "as well as or better than" the predicate device, indicating that performance comparable to or exceeding the predicate device's established levels constitutes acceptance.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied by Predicate Performance) | Reported CARESIDE LYTES™ Performance |
|---|---|---|
| Sodium (Na) | ||
| Detection Limit | 95 mmol/L | 75 mmol/L |
| Reportable Range | 95 to 215 mmol/L | 75 to 240 mmol/L |
| Accuracy | Not provided for predicate | Mean recovery 99% |
| Precision (Total CV) | 1.3% at 143 mmol/L | 1.5% at 146 mmol/L |
| Method Comparison (vs. Reference) | N/A | 1.01 (Flame Photometry) - 1.34 mmol/L, r= 1.00 |
| Method Comparison (vs. Predicate) | N/A | 1.04 (Vitros Na⁺) - 2.78 mmol/L, r = 0.99 |
| Interference | Ethanol and benzalkonium chloride cause positive interference | No significant interference observed at tested concentration |
| Potassium (K) | ||
| Detection Limit | 1.0 mmol/L | 1.0 mmol/L |
| Reportable Range | 1.0 to 11.0 mmol/L | 1.0 to 14.0 mmol/L |
| Accuracy | Not provided for predicate | Mean recovery 99% |
| Precision (Total CV) | 1.4% at 5.2 mmol/L | 1.8% at 5.4 mmol/L |
| Method Comparison (vs. Reference) | N/A | 1.00 (Flame Photometry) + 0.01 mmol/L, r= 1.00 |
| Method Comparison (vs. Predicate) | N/A | 1.07 (Vitros K⁺) - 0.16 mmol/L, r = 1.00 |
| Interference | None | No significant interference observed at tested concentration |
| Chloride (Cl) | ||
| Detection Limit | 65 mmol/L | 50 mmol/L |
| Reportable Range | 65 to 140 mmol/L | 50 to 170 mmol/L |
| Accuracy | Not provided for predicate | Mean recovery 102% |
| Precision (Total CV) | 1.5% at 108 mmol/L | 1.3% at 107 mmol/L |
| Method Comparison (vs. Reference) | N/A | 0.98 (Coulometry) + 2.13 mmol/L, r= 0.99 |
| Method Comparison (vs. Predicate) | N/A | 0.97 (Vitros Cl⁻) + 2.54 mmol/L, r = 0.99 |
| Interference | Bromide and iodide cause positive interference | Bromide causes positive interference (Iodide: No significant interference observed) |
Note: Acceptance criteria are inferred based on the predicate device's performance where direct criteria are not explicitly stated for the CARESIDE LYTES™ device. The submission aims to prove substantial equivalence, meaning performance should be comparable or better.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set in terms of number of patient samples. It provides performance metrics like "Mean recovery", "Total CV" at specific concentrations, and "Method comparison" data (slope, intercept, and correlation coefficient r). This suggests a series of experiments were conducted.
The data provenance is not explicitly stated. However, given it's a 510(k) submission to the FDA, the data would typically originate from studies conducted under controlled laboratory conditions, likely in the US, and may involve both prospective lab-controlled samples and potentially retrospective clinical samples. The type of study presented here (method comparison, linearity, interference) is generally prospective laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device. The ground truth for chemical analytes like sodium, potassium, and chloride is established using recognized reference methods (e.g., Flame Photometry for Na/K, Coulometry for Cl) performed by qualified laboratory personnel, not by medical experts making diagnostic assessments. The document explicitly lists these reference methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable to this type of chemical analyzer validation. Adjudication methods are typically used in studies where subjective interpretation (e.g., image reading) requires consensus among experts. Here, the "ground truth" is determined by objective analytical measurements from established reference instruments.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. The CARESIDE LYTES™ is an in vitro diagnostic device for quantitative chemical analysis, not an AI or imaging device involving human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done. The reported performance characteristics (Detection limit, Reportable range, Accuracy, Precision, Method comparison, Linearity, Interference) all reflect the intrinsic analytical performance of the CARESIDE LYTES™ cartridge and CARESIDE Analyzer™ system without human interpretative intervention in the measurement result. The device automates the measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance studies was established using recognized reference methods:
- Sodium: Flame Photometry
- Potassium: Flame Photometry
- Chloride: Coulometry
8. The sample size for the training set
The document does not provide information on a "training set" in the context of machine learning or AI. This device is an analytical instrument based on established electrochemical principles, not a machine learning model that requires training data in the conventional sense. The development likely involved calibration and verification studies, but these are not typically referred to as "training sets" for this type of device.
9. How the ground truth for the training set was established
This question is not applicable as there is no mention or indication of a "training set" for an AI or machine learning model in this submission. The device's functionality is based on established electrochemical principles and analytical validation.
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