RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT

K131554 · Randox Laboratories, Ltd. · JJE · Jan 9, 2014 · Clinical Chemistry

Device Facts

• Record ID: K131554
• Device Name: RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJE · Clinical Chemistry
• Decision Date: Jan 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2160
• Device Class: Class 1

Intended Use

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.

Device Story

RX Daytona Plus is a bench-top, fully automated, random-access clinical chemistry analyzer for laboratory use. It processes serum and urine samples via photometric analysis or an optional Ion Selective Electrode (ISE) module. The system performs sample pipetting, reagent mixing, and reaction incubation in cuvettes. Photometric tests use a halogen tungsten lamp and diffraction grating; ISE tests use ion-selective electrodes based on the Nernst equation. The device provides automated re-run, pre-dilution, and STAT capabilities. Data is managed via integrated software and output to a host computer via LIMS connectivity. Results assist clinicians in diagnosing liver/heart disease and electrolyte imbalances. Benefits include high throughput (up to 450 tests/hour with ISE), reduced manual labor, and standardized diagnostic accuracy.

Clinical Evidence

Bench testing only. Precision studies (CLSI EP5) evaluated AST, Na, K, and Cl in serum and urine over 20 days. Linearity (CLSI EP6) confirmed reportable ranges. Method comparison (CLSI EP9-A2) against predicate showed high correlation (r=0.990–0.999). Interference studies assessed hemoglobin, bilirubin, triglycerides, and intralipid. Reference intervals verified per NCCLS C28-A2.

Technological Characteristics

Bench-top, fully automated, random-access analyzer. Photometric detection (12 wavelengths, 340-750nm) and ISE module (Na, K, Cl). Uses halogen tungsten lamp, resin cuvettes, and dedicated sample/reagent micropipettes with liquid level sensing and crash detection. Connectivity via bi-directional ASTM standard LIMS. Software-controlled operation with automated dilution and re-run. Sterilization not applicable; reagents are liquid, ready-to-use.

Indications for Use

Indicated for clinical laboratory use for quantitative measurement of AST in human serum and sodium, potassium, and chloride in serum and urine. Not for point-of-care testing.

Regulatory Classification

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.

Predicate Devices

• Randox RX Imola Chemistry Analyzer with ISE Sodium, Potassium and Chloride electrodes (K052914)
• Randox AST assay (K923505)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k131554

B. Purpose for Submission:
Adding previously cleared assays on a new instrument platform

C. Measurand:
Aspartate Aminotransferase, Sodium, Potassium, and Chloride

D. Type of Test:
Quantitative, enzymatic and potentiometric measurement with Ion-Selective Electrodes

E. Applicant:
Randox Laboratories Limited

F. Proprietary and Established Names:
RX Daytona Plus Chemistry analyzer
RX Daytona Plus Aspartate amino transferase (AST) reagent

G. Regulatory Information:

| Product Code | Regulation Name | Classification | Regulation Section | Panel |
| --- | --- | --- | --- | --- |
| CIT | Aspartate amino transferase (AST/SGOT) Test system | II | 21 CFR 862.1100 | Chemistry (75) |
| JGS | Sodium Test System | II | 21 CFR 862.1665 | Chemistry (75) |
| CEM | Potassium Test System | II | 21 CFR 862.1600 | Chemistry (75) |
| CGZ | Chloride Test System | II | 21 CFR 862.1170 | Chemistry (75) |
| JJE | Discrete photometric chemistry analyzer for clinical use | I | 21 CFR 862.2160 | Chemistry (75) |

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H. Intended Use:

1. Intended use(s):

See indication(s) for use below

2. Indication(s) for use:

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.

3. Special conditions for use statement(s):

For Prescription Use Only

4. Special instrument requirements:

RX Daytona Plus chemistry analyzer with ISE module

I. Device Description:

The RX Daytona Plus analyzer with optional ISE is an automated, in-vitro analyzer capable of performing clinical chemistry and electrolyte tests. The analyzer is offered in two formats (with ISE module for measuring sodium, potassium and chloride electrometrically and without ISE module). The RX Daytona Plus is a bench-top fully automated random access clinical analyzer. 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.

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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 access to all system facilities and functions. A color, graphic user interface guides through the operating functions and provides a data management system.

The ISE module is comprised of the ISE (sodium, potassium, and chloride) electrodes, plus ISE cleaning solution, ISE reference solution, ISE etching solution and ISE calibrators (L and H solution). The ISE calibrators consist of 2 levels: Lo solution and High. Calibrators are supplied in liquid ready-to-use form and are aqueous solutions containing sodium, potassium and chloride. The ISE module has been previously cleared in k052914.

The Randox AST reagent consists of 2 reagents: Reagent 1 contains Tris buffer, L-Aspartic Acid, Malate Dehydrogenase (MDH), and Lactate Dehydrogenase (LD). The R2 reagent contains $\alpha$ -oxoglutarate and NADH. This reagent has been previously cleared in k923505.

# J. Substantial Equivalence Information:

1. Predicate device name(s):

Randox AST assay

Randox RX Imola Analyzer

2. Predicate $510(\mathbf{k})$ number(s):

k923505 and k052914 respectively.

3. Comparison with predicate:

AST

| Similarities and Differences | | |
| --- | --- | --- |
| Item | Randox Daytona Plus AST Reagent (Candidate device) | Randox AST Reagent k923505 (Predicate device) |
| Intended Use | For the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate aminotransferase (AST) in human serum. | Same |
| Sample Type | Serum | Serum or Plasma |

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| Similarities and Differences | | |
| --- | --- | --- |
| Item | Randox Daytona Plus AST Reagent (Candidate device) | Randox AST Reagent k923505 (Predicate device) |
| Assay method | UV method | Same |
| Reagent format | Liquid, ready to use | Same |
| Calibration frequency | Every 28 days or as needed | Same |

RX Daytona plus analyzer

| Similarities and Differences | | |
| --- | --- | --- |
| Item | RX Daytona Plus Analyzer (Candidate device) | RX Imola Automated Analyzer (Predicate device) k052914 |
| Intended use | Automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods. | Same |
| Technology | Spectrophotometric and electrochemical tests | Same |
| Assay Methods | Monochromatic, bi-chromatic, endpoint, kinetic, sample and reagent blanking and ISE (via optional integrated ISE) | Endpoint, Kinetic, Bichromatic, turbidimetric, sample blanking, reagent blanking and ISE. |
| Calibration Principle | Factor, Linear, Point to point, Log- logit, Exponential, Spline, Spline 2 and ISE | Factor, Linear, 2 point, point to point, spline, log-logit, exponential and ISE |
| Cuvettes | 72 resin cuvettes (semi-disposable) (volume, 100ul min, 350ul max) | 90 reusable pyrex cuvettes (volume, 150ul min, 450ul max) |
| Cycle Time | 13 seconds | 9 seconds |
| Detection Principle | 12 wavelengths generated via diffraction grating:340, 380,415, 450,510,546,570,600,660,700,750 | Same |
| ISE module: | | |
| Technology | Indirect potentiometry measurement with Ion-Selective Electrode | Same |
| Sample Type | Serum and Urine | Same |

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| Similarities and Differences | | |
| --- | --- | --- |
| Item | RX Daytona Plus Analyzer (Candidate device) | RX Imola Automated Analyzer (Predicate device) k052914 |
| Calibration frequency | Calibration is recommended for every 8 hours or as needed | Every 24 hours or as needed. |

## K. Standard/Guidance Document Referenced (if applicable):

CLSI-EP-17A- Protocols for Determination of Limits of Detection and Limits of Quantitation

CLSI-EP-09-A2- Method Comparison and Bias estimation using patient samples

CLSI-EP-05-A2- Evaluation or Precision of Quantitative Measurement Methods

CLSI-EP-07-A2- Interference Testing in Clinical Chemistry

CLSI-EP-06-A- Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach

CLSI-C28-A3- Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory

## L. Test Principle:

AST measurements are based on A-oxoglutarate reacts with L-aspartine in the presence of AST to form L-glutamate plus oxaloacetate. The indicator reaction utilizes the oxaloacetate for a kinetic determination of NADH consumption.

The RX Daytona Plus analyzer with optional ISE is based on the potentiometric Nernst Equation principle. Sample is diluted with a diluent and aspirated into ion-selective electrodes. The measured potential difference between the reference electrode and the ion specific electrode is proportional to the logarithm of the concentration of the measured ions.

## M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

**AST Reagent**

Precision was evaluated using 3 unaltered human serum samples at low, medium and high levels and 1 human serum sample spiked with AST to a concentration of 850

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U/L. Three additional samples (1 calibrator and 2 control samples) were also tested. All samples were tested in duplicate twice a day for 20 days on the Randox RX Daytona Plus analyzer following CLSI-EP5-A2 guideline. Results are summarized in the table below:

AST

| Material | n | Mean (U/L) | Within-run | | Total | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV (%) | SD | CV (%) |
| Control 1 | 40 | 161.74 | 2.23 | 1.4 | 2.69 | 1.7 |
| Control 2 | 40 | 37.83 | 1.14 | 3.0 | 1.29 | 3.4 |
| Control 3 (CAL) | 40 | 142.95 | 1.82 | 1.3 | 2.20 | 1.5 |
| Serum sample 1 | 40 | 391.33 | 2.26 | 0.6 | 9.47 | 2.4 |
| Serum sample 2 | 40 | 18.83 | 0.43 | 2.3 | 1.08 | 5.8 |
| Serum sample 3 | 40 | 850.27 | 4.57 | 0.5 | 11.62 | 1.4 |

# Sodium

Precision was evaluated using 3 unaltered human serum samples (pools 1, 2 and 3) and two levels of quality control for serum. Urine precision was evaluated using 2 unaltered human urine samples (pools 1 and 2) and two urine based quality control samples. All samples were tested in duplicate twice a day for 20 days on the Randox RX Daytona Plus analyzer following CLSI-EP-5-A2 guideline. Results are summarized in the table below:

Sodium-Serum

| Material | n | Mean (mmol/L) | Within-run | | Total | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV (%) | SD | CV (%) |
| Control 1 | 40 | 154.46 | 2.14 | 1.4 | 2.19 | 1.4 |
| Control 2 | 40 | 138.28 | 1.62 | 1.2 | 3.39 | 2.4 |
| Patient Pool 1 | 40 | 108.73 | 1.52 | 1.4 | 1.65 | 1.5 |
| Patient Pool 2 | 40 | 134.70 | 1.40 | 1.0 | 1.46 | 1.1 |
| Patient Pool 3 | 40 | 174.60 | 2.08 | 1.2 | 2.90 | 1.7 |

Sodium-Urine

| Material | n | Mean (mmol/L) | Within-run | | Total | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV (%) | SD | CV (%) |
| Control 1 | 40 | 61.84 | 2.59 | 4.2 | 3.44 | 5.6 |
| Control 2 | 40 | 192.25 | 6.2 | 3.2 | 9.34 | 4.9 |
| Patient Pool 1 | 40 | 135.65 | 4.05 | 3.0 | 7.51 | 5.5 |
| Patient Pool 2 | 40 | 281.59 | 5.37 | 1.9 | 12.02 | 4.3 |

# Potassium

Precision was evaluated using 3 unaltered human serum samples (pools 1, 2 and 3) and two levels of quality control for serum. Urine precision was evaluated using 2

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unaltered human urine samples (pools 1 and 2) and two urine based quality control samples. All samples were tested in duplicate twice a day for 20 days on the Randox RX Daytona Plus analyzer following CLSI-EP-5-A2 guideline. Results are summarized below:

Potassium-Serum

| Material | n | Mean (mmol/L) | Within-run | | Total | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV (%) | SD | CV (%) |
| Control 1 | 40 | 6.0 | 0.06 | 1.1 | 0.08 | 1.3 |
| Control 2 | 40 | 4.0 | 0.06 | 1.4 | 0.07 | 1.7 |
| Patient Pool 1 | 40 | 3.3 | 0.05 | 1.6 | 0.06 | 1.9 |
| Patient Pool 2 | 40 | 4.6 | 0.09 | 1.9 | 0.09 | 2.0 |
| Patient Pool 3 | 40 | 6.7 | 0.08 | 1.2 | 0.11 | 1.7 |

Potassium-Urine

| Material | n | Mean (mmol/L) | Within-run | | Total | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV (%) | SD | CV (%) |
| Control 1 | 40 | 32.7 | 0.55 | 1.7 | 0.97 | 3.0 |
| Control 2 | 40 | 103.2 | 2.08 | 2.0 | 4.52 | 4.4 |
| Patient Pool 1 | 40 | 31.9 | 0.57 | 1.8 | 0.87 | 2.7 |
| Patient Pool 2 | 40 | 84.3 | 2.04 | 2.4 | 2.98 | 3.5 |

Chloride

Precision was evaluated using 3 unaltered human serum samples (pools 1, 2 and 3) and two levels of quality control for serum. Urine precision was evaluated using 2 unaltered human urine samples (pools 1 and 2) and two urine based quality control samples. All samples were tested in duplicate twice a day for 20 days on the Randox RX Daytona Plus analyzer following CLSI-EP-5-A2 guideline. Results are summarized below:

Chloride-Serum

| Material | n | Mean (mmol/L) | Within-run | | Total | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV (%) | SD | CV (%) |
| Control 1 | 40 | 114.86 | 1.29 | 1.1 | 1.95 | 1.7 |
| Control 2 | 40 | 100.35 | 1.40 | 1.4 | 1.58 | 1.6 |
| Patient Pool 1 | 40 | 88.84 | 1.87 | 2.1 | 1.94 | 2.2 |
| Patient Pool 2 | 40 | 105.73 | 1.07 | 1.0 | 1.49 | 1.4 |
| Patient Pool 3 | 40 | 134.13 | 1.75 | 1.3 | 2.49 | 1.9 |

Chloride-Urine

| Material | n | Mean (mmol/L) | Within-run | | Total | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV (%) | SD | CV (%) |
| Control 1 | 40 | 86.44 | 3.15 | 3.6 | 4.66 | 5.4 |
| Control 2 | 40 | 240.25 | 5.23 | 2.2 | 15.04 | 6.3 |

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| Patient Pool 1 | 40 | 171.06 | 4.98 | 2.9 | 7.30 | 4.3 |
| --- | --- | --- | --- | --- | --- | --- |
| Patient Pool 2 | 40 | 260.24 | 3.74 | 1.4 | 7.75 | 3.0 |

# b. Linearity/assay reportable range:

A linearity study was conducted for AST, sodium, potassium and chloride using low and high sample pools to create 11 sample levels across the measuring range of the device for both serum and urine samples types. All samples were measured in triplicate on the Randox RX Daytona Plus Analyzer. The observed results (obtained on the RX Daytona Plus Analyzer) for AST, sodium, potassium and chloride were plotted against the expected values and an appropriate line fitted by standard linear regression resulted in the following:

Serum

| Analyte | Serum reportable range | Linear regression |
| --- | --- | --- |
| AST | 5-1116 U/L | y=1.00x+0.65; R²=1.000 |
| Sodium | 90-226 mmol/l | y=1.05x-5.45; R²=0.999 |
| Potassium | 0.5-11 mmol/l | y=1.02x-0.13; R²=0.999 |
| Chloride | 72-210 mmol/l | y=0.99x+1.14; R²=0.998 |

Urine

| Analyte | Urine reportable range | Linear regression |
| --- | --- | --- |
| Sodium | 45-318 mmol/l | y=0.95x+7.26; R²=0.998 |
| Potassium | 1.5-168 mmol/l | y=1.03x-1.20; R²=1.000 |
| Chloride | 61-319 mmol/l | y=0.96x+3.41;R²=0.999 |

# c. Traceability, Stability, Expected values (controls, calibrators, or methods):

| Device | Traceability |
| --- | --- |
| AST | Standardized against primary calibrators traceable to AST reference material JSCC TS01 |
| ISE: Sodium, Potassium and Chloride | Standardized against primary calibrators prepared gravimetrically from purified salts |

# Stability

On board stability for the AST reagent and ISE reagents was established by real time studies on the Randox Daytona Plus system. The on-board stability of the reagent is 45 days. The AST reagent is stable until the expiration date printed on the label when stored at $2 - 8^{\circ}\mathrm{C}$ . Acceptance criteria and study protocol have been provided and found to be adequate.

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According to the sponsor, the on-board and open stability claims for the ISE reagents are as follows when stored at $15 - 25^{\circ}\mathrm{C}$ :

| Component | Open Stability |
| --- | --- |
| ISE cleaning solution | 6 months |
| ISE ref solution | 1 month |
| ISE etching solution | 12 months |
| L solution (ISE Calibrator ) | 1 month |
| H solution (ISE Calibrator ) | 1 month |

Calibrators for AST assay: The Randox clinical chemistry calibration serum level 2 & 3 (previously cleared under k053153) are the recommended calibrators for use with this device. The Randox clinical chemistry calibrators, when reconstituted, are stable for 8 hours at $15 - 25^{\circ}\mathrm{C}$ or 7 days at $2 - 8^{\circ}\mathrm{C}$ , and 1 month when frozen once at $-20^{\circ}\mathrm{C}$ .

Controls for both AST assay and ISE module: The Randox assayed human multi-sera level 2 & 3 (previously cleared under k942458) are the recommended controls for use with this device. The controls, when reconstituted, are stable for 8 hours at $15 - 25^{\circ}\mathrm{C}$ or 7 days at $2 - 8^{\circ}\mathrm{C}$ , and 1 month when frozen once at $-20^{\circ}\mathrm{C}$ .

# d. Detection limit:

A detection limit study was evaluated according to CLSI EP-17A. The Limit of Blank (LoB) was determined by assaying a blank sample 120 times on the Randox Daytona Plus analyzer. The LoB was determined by using the $95\%$ value.

The limit of detection (LoD) was determined by assaying 120 replicates of two low level AST samples which were prepared by spiking AST into stripped human serum. The stock solution containing pure AST was added volumetrically to produce the 2 samples with desired concentrations of 0.5 and $1.0\mathrm{U / L}$ of AST. The LoD was determined using the median minus the $5^{\mathrm{th}}$ percentile plus the LoB value.

The Limit of Quantitation (LoQ) was determined by assaying 120 replicates of 7 low AST sample pools. The LoQ was determined as the lowest concentration sample that had a $\% \mathrm{CV}$ of $\leq 20\%$ .

| Analyte | LoB | LoD | LoQ |
| --- | --- | --- | --- |
| AST | 0.50 U/L | 1.37 U/L | 5.0 U/L |

The claimed measuring range is 5-1116 U/L for the AST assay.

The claimed measuring ranges of the ISE electrolytes were based on the linearity study and are summarized in the table below.

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| Analyte | Serum reportable range | Urine reportable range |
| --- | --- | --- |
| Sodium | 90-226 mmol/l | 45-318 mmol/l |
| Potassium | 0.5-11 mmol/l | 1.5-168 mmol/l |
| Chloride | 72-210 mmol/l | 61-319 mmol/l |

# e. Analytical specificity:

Testing for interfering substances was based on CLSI EP-7A2. Testing for each analyte was performed at two concentration levels (low and high) using interfering substances at five difference concentration levels. Samples with increasing amounts of Hemoglobin, Bilirubin (total and conjugated), Intralipid and Triglycerides for AST plus Bromide, Ascorbic Acid, Thyiocyanate, Lithium, and salicylic acid were tested for sodium, potassium and chloride and compared to samples that did not contain the interfering substance.

The sponsor defined non-significant interference as the highest level tested that does not cause $>10\%$ change between the tested samples and the control samples.

AST

| | Highest concentration tested that showed no significant interference |
| --- | --- |
| Hemoglobin | interferes |
| Total Bilirubin | 60 mg/dl |
| Bilirubin (conjugated) | 60 mg/dl |
| Intralipid | 500 mg/dl |
| Triglycerides | 500 mg/dl |

The labeling states that serum samples free from hemolysis should be used with this AST assay.

Sodium, Potassium and Chloride Serum Interference summary showing highest concentration that does not interfere

| Interferent | Sodium | Potassium | Chloride |
| --- | --- | --- | --- |
| Hemoglobin | 500 mg/dl | 62.5 mg/dl | 750 mg/dl |
| Total Bilirubin | 60 mg/dl | 60 mg/dl | 30 mg/dl |
| Bilirubin (conjugated) | 60 mg/dl | 60 mg/dl | 60 mg/dl |
| Intralipid | 2000 mg/dl | 1500 mg/dl | 2000 mg/dl |
| Triglycerides | 2000 mg/dl | 2000 mg/dl | 2000 mg/dl |
| Bromide | 37.5 mmol/L | Interferes causes false ↑ | Interferes causes false ↑ |
| Ascorbic Acid | 342 mmol/l | 342 mmol/l | 342 mmol/l |
| Thyiocyanate | 6.88 mmol/l | 6.88 mmol/l | Interferes causes false ↑ |

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The labeling states non-hemolyzed samples should be used as hemolyzed samples will elevate potassium.

Labeling also states Thyiocyanate and Salicylic acid will cause falsely elevated Chloride concentrations and Bromide will cause falsely elevated Chloride and Potassium concentrations.

Sodium, Potassium and Chloride Urine Interference summary showing highest concentration that does not interfere

| Interferent | Sodium | Potassium | Chloride |
| --- | --- | --- | --- |
| Hemoglobin | 500 mg/dl | 500 mg/dl | 750 mg/dl |
| Total Bilirubin | 60 mg/dl | 60 mg/dl | 30 mg/dl |
| Bilirubin (conjugated) | 30 mg/dl | 60 mg/dl | 45 mg/dl |
| Intralipid | 2000 mg/dl | 2000 mg/dl | 1500 mg/dl |
| Triglycerides | 2000 mg/dl | 2000 mg/dl | 2000 mg/dl |

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

All method comparison studies were performed at the manufacturer's site.

AST

A method comparison study was performed using the Randox Rx Imola analyzer (predicate device) versus the Randox RX Daytona Plus Analyzer (candidate device). A total of 92 patient serum samples were analyzed in singlicate. The samples spanned the range of 5.0 – 817.0 U/L. Of these 92 samples, 0 were diluted and 6 were spiked. The results are presented in the table below.

ISE (NA⁺, K⁺, Cl⁻)

A method comparison study was performed using the Randox Rx Imola analyzer (predicate device) versus the Randox RX Daytona Plus Analyzer with ISE module. A total of 50 samples were analyzed for Sodium (all native patient samples), 56 samples for Potassium (5 diluted, 0 spiked) and 61 samples for Chloride (3 diluted and 3 spiked). The results are presented in the table below.

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| Analyte | Units | Range | Total | Slope | Intercept | R2 |
| --- | --- | --- | --- | --- | --- | --- |
| AST | U/L | 5.0-817 | 92 | 1.03 | 2.33 | 0.999 |
| Na+ | mmol/l | 105-194 | 50 | 1.04 | -9.57 | 0.990 |
| K+ | mmol/l | 0.75-9.58 | 56 | 1.02 | -0.13 | 0.997 |
| Cl- | mmol/l | 81.3-189.3 | 61 | 1.03 | -1.16 | 0.970 |

# Urine

# ISE $(\mathrm{NA}^{+},\mathrm{K}^{+},\mathrm{Cl}^{-})$

A method comparison study was performed using the Randox Rx Imola analyzer (predicate device) versus the Randox RX Daytona Plus Analyzer with ISE module. A total of 42 samples were analyzed for Sodium, 43 samples for Potassium and 49 samples were analyzed for Chloride. No more than $20\%$ of the samples were altered. The results are presented in the table below.

| Analyte | Units | Range | Total | Slope | Intercept | R2 |
| --- | --- | --- | --- | --- | --- | --- |
| Na+ | mmol/l | 54.9-288.5 | 42 | 1.01 | -7.99 | 0.996 |
| K+ | mmol/l | 10.6-145.1 | 43 | 1.04 | -1.48 | 0.999 |
| Cl- | mmol/l | 74.1-287.2 | 44 | 0.97 | 5.08 | 0.997 |

# b. Matrix comparison:

# AST

Serum only

# ISE $(\mathrm{NA}^{+},\mathrm{K}^{+},\mathrm{Cl}^{-})$

Serum and urine only

# 3. Clinical studies:

# a. Clinical Sensitivity:

Not applicable

# b. Clinical specificity:

Not applicable

# c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable

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4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

Reference Values are provided in the labeling according to literature as follows:

| Analyte | Serum | Urine |
| --- | --- | --- |
| AST^{1} | Men-Up to 35 U/L; Women up to 31 U/L | N/A |
| Sodium (Na^{+})^{2} | 136-145 mmol/l | 40-220 mmol/24h |
| Potassium (K^{+})^{2} | 3.5-5.1 mmol/l | 25-125 mmol/24h |
| Chloride (Cl^{-})^{2} | 98-107 mmol/l | 110-250 mmol/24h |

¹Schumann G, Klauke R. New IFCC reference procedures for the determination of catalytic activity concentrations of five enzymes in serum; preliminary upper reference limits obtained in hospitalized subjects. Clin Chem Acta 2003; 327 (1-2) 69-79.

²Tietz NW, Pruden EL, Siggaard-Andersen O. Electrolytes. In: Burtis CA, Ashwood ER, eds. Tietz Textbook of Clinical Chemistry. 2nd ed. Philadelphia: WB Saunders 1994:1354-1374.

In the labeling, the sponsor recommends that each laboratory should establish and maintain its own reference values.

N. Instrument Name:

Randox RX Daytona Plus Chemistry analyzer

O. System Descriptions:

1. Modes of Operation:

Automated continuous random access analyzer.

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes ☐ X ☐ or No ☐

3. Specimen Identification:

Barcoding or Manual Entry

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4. Specimen Sampling and Handling:

Samples in sample tubes or sample cups with a tube adaptor are places into sample tray and automatically measured by the analyzer.

5. Calibration:

Sponsor recommends that user perform a calibration and a quality control measurement after installing a new lamp, new lot of reagent or a fresh bottle of reagent. ISE calibration is recommended every 8 hours or when quality control results fall outside the established ranges. It is recommended that AST be calibrated every 28 days or as needed.

6. Quality Control:

The software contains a quality control program that evaluated control results and determined if they are within specified acceptable limits.

In the labeling the sponsor recommends that control measurements be assayed daily and the frequency depends on the test method. Quality control materials should be used in accordance with local, state and/or federal guidelines.

P. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

Q. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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