(224 days)
The RX Daytona Plus Chemistry analyzer is a bench top fully automated random access clinical chemistry analyzer intended for use in clinical laboratories. It is intended to be used for a variety of assay methods. The RX Daytona Plus includes an optional Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum and urine. The RX Daytona Plus is not for Point-Of-Care testing.
Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
The RX Daytona Plus AST reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate aminotransferase (AST) in human serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
The RX Daytona Plus is a bench-top fully automated random access clinical analyser intended for use in clinical laboratories.
The RX Daytona Plus contains an ISE .module for the measurement of Potassium, Chloride and Sodium. The RX Daytona Plus has the capacity to perform up to 270 photometric tests or 450 tests per hour with ISE's and offers primary tube sampling, on-board sample dilution and a cooled reagent compartment.
- Cuvette wash system .
- STAT facility .
- Direct interface with host computer .
- . Automatic re-run and pre-dilution functions
The RX Daytona Plus uses dedicated software for easy access to all system facilities and functions. operating functions and provides a comprehensive data management system.
Reagents:
AST reagent is supplied in a kit containing:
- . 4 x 20.0 mL Buffer/ enzyme
- . 4 x 7.0 mL α-οχοςlutarate/Coenzyme.
The primary reagent contains L-Aspartic acid, MDH, Tris Buffer and preservative, The secondary reagent contains a-oxoglutarate, NADH and preservatives.
ISE Electrodes, Sodium, Potassium and Chloride are comprised of ISE Calibrator H and L, ISE diluent, ISE reference solution and ISE etching solution.
Here's a summary of the acceptance criteria and study information for the RX Daytona Plus Instrument, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implied by the results of the precision, linearity, detection limit, analytical specificity, and method comparison studies. The device aims to demonstrate substantial equivalence to its predicate devices for each analyte (AST, Sodium, Potassium, Chloride) in the relevant sample types (serum, urine). The performance metrics reported directly represent if these implied criteria were met.
| Performance Characteristic | Analyte | Sample Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|---|
| Precision (Total CV) | AST | Serum | Low variability | 1.4% - 12.2% |
| Sodium | Serum | Low variability | 1.1% - 3.1% | |
| Sodium | Urine | Low variability | 4.3% - 5.6% | |
| Potassium | Serum | Low variability | 1.3% - 3.9% | |
| Potassium | Urine | Low variability | 2.7% - 4.4% | |
| Chloride | Serum | Low variability | 1.6% - 3.6% | |
| Chloride | Urine | Low variability | 3.0% - 6.3% | |
| Linearity (R²) | AST | Serum | Close to 1.0 | 1.000 (Range: 5 – 1116 U/L) |
| Sodium | Serum | Close to 1.0 | 0.999 (Range: 90 – 226 mmol/L) | |
| Sodium | Urine | Close to 1.0 | 0.998 (Range: 45 – 318 mmol/L) | |
| Potassium | Serum | Close to 1.0 | 0.999 (Range: 0.5 – 11 mmol/L) | |
| Potassium | Urine | Close to 1.0 | 1.000 (Range: 1.5 – 168 mmol/L) | |
| Chloride | Serum | Close to 1.0 | 0.998 (Range: 72 – 210 mmol/L) | |
| Chloride | Urine | Close to 1.0 | 0.999 (Range: 61 – 319 mmol/L) | |
| Detection Limit | AST | Serum | Defined LoD/LoQ | LoD: 1.372 U/L, LoQ: 5 U/L |
| Analytical Specificity | All | Serum/Urine | No significant interference | Varies by interferent (see tables 12-15). Note: Hemoglobin interferes with AST and Potassium; Bromide, Thiocyanate, and Salicylic acid interfere with Chloride and Potassium. |
| Method Comparison (r) | AST | Serum | High correlation to predicate | 0.999 |
| Sodium | Serum | High correlation to predicate | 0.990 | |
| Sodium | Urine | High correlation to predicate | 0.996 | |
| Potassium | Serum | High correlation to predicate | 0.997 | |
| Potassium | Urine | High correlation to predicate | 0.999 | |
| Chloride | Serum | High correlation to predicate | 0.990 | |
| Chloride | Urine | High correlation to predicate | 0.997 | |
| Expected Values | All | Serum | Fall within established ranges | All values reported in the range for Healthy Individuals (for Na, K, Cl) |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Precision/Reproducibility:
- AST, Sodium, Potassium, Chloride (Serum): Two levels of control material, calibration material, unaltered human serum samples, and altered human serum samples. Tested twice per day for 20 non-consecutive days, with two replicates per sample. This totals approximately 80 test points per sample type for control/calibrator, and 40 test points per patient pool (20 days * 2 replicates).
- Sodium, Potassium, Chloride (Urine): Two levels of urine controls and two urine patient pools. Tested twice per day for 20 non-consecutive days, with two replicates per sample. Totals approximately 80 test points per control, and 40 test points per patient pool.
- Data Provenance: Not explicitly stated, but the submission is from Randox Laboratories Limited in the United Kingdom, suggesting the studies were likely conducted there. The samples were human serum and urine. Retrospective or prospective nature is not specified, but the "non-consecutive days" suggests prospective testing over a period.
-
Linearity/Assay Reportable Range:
- AST, Sodium, Potassium, Chloride (Serum & Urine): Studies performed at 11 levels.
- Data Provenance: Implied to be derived from the UK.
-
Detection Limit (AST):
- 360 determinations, with 1 blank and 2 low-level samples.
- Data Provenance: Implied to be derived from the UK.
-
Analytical Specificity (Interference):
- Interferents (Hemoglobin, Bilirubin, Triglycerides, Intralipid, various drugs) were "spiked" into relevant control/sample solutions. The number of samples/replicates isn't specified beyond this.
- Data Provenance: Implied to be derived from the UK.
-
Method Comparison with Predicate Device:
- AST (Serum): 92 serum patient samples.
- Sodium (Serum): 50 serum patient samples.
- Sodium (Urine): 42 urine patient samples.
- Potassium (Serum): 56 serum patient samples.
- Potassium (Urine): 43 urine patient samples.
- Chloride (Serum): 61 serum patient samples.
- Chloride (Urine): 44 urine patient samples.
- All samples were tested in singlicate across 5 working days.
- Data Provenance: Not explicitly stated, but given the submitter's location (UK), the data is most likely from the UK. The studies used "patient samples," which suggests real-world specimens, likely collected prospectively for the purpose of the study or retrospectively from a patient cohort.
-
Expected Values/Reference-range Verification:
- Sodium, Potassium, Chloride (Serum): Human serum from 30 normal donors, tested in singlicate.
- Data Provenance: Implied to be derived from the UK.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a clinical chemistry analyzer. The "ground truth" for the test set values (e.g., concentrations of AST, sodium) is established by reference methods or validated laboratory procedures, not by human expert interpretation like in imaging studies. The predicate device's performance also serves as a benchmark.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in subjective diagnostic tasks, such as radiology image interpretation. In this context, the "ground truth" values for chemical analytes are obtained through highly standardized and quantitative laboratory methods (e.g., reference methods, predicate device results).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for evaluating the impact of AI on human readers' performance in diagnostic tasks (e.g., radiology). This device is a fully automated chemistry analyzer, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, essentially all the performance data (precision, linearity, detection limits, analytical specificity, method comparison) reflects the standalone performance of the RX Daytona Plus Chemistry Analyzer as an automated instrument. There is no human-in-the-loop aspect for the analysis itself; human intervention is only involved in loading samples and interpreting the final results generated by the machine.
7. The Type of Ground Truth Used
The ground truth for the performance studies was established using a combination of:
- Reference materials/control materials: For precision and linearity studies.
- Validated methods/Predicate device results: For method comparison studies, where the results from the RX Daytona Plus were compared against a legally marketed predicate device (Randox RX Imola Chemistry Analyzer with ISE, Randox AST assay).
- Gravimetric preparation from purified salts: For ISE (Sodium, Potassium, Chloride) calibrators traceability.
- Standardized reference procedures (JSCC TS01): For AST traceability.
- Clinical literature: For establishing expected values/reference ranges.
8. The Sample Size for the Training Set
Not applicable. This is a traditional automated chemistry analyzer, not a machine learning or AI-driven device that requires a training set in the typical sense. The "parameters" and "algorithms" (e.g., Nernst equation for ISE, kinetic reaction for AST) are based on established chemical and physical principles, not learned from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The operating principles are based on fundamental scientific laws and established chemical diagnostic assays.
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.