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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KI 31554

510(K) Summary RX Daytona Plus Instrument

## 510(K) SUMMARY

JAN - 9 2014

## 1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92 STATEMENT

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92.

## 2. SUBMITTER NAME AND ADDRESS

Name: Randox Laboratories Limited

Address: 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.

Telephone: [phone] Fax: [phone]

Contact: Dr Pauline Armstrong E-mail: [e-mail]

#### 3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME. PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL. PRODUCT CODE AND 21 CFR NUMBER

| Product Code | Regulation Name | Classification | Regulation Section | Panel |
|--------------|----------------------------------------------------------------|----------------|--------------------|----------------|
| CIT | Aspartate amino<br>transferase (AST/SGOT)<br>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<br>chemistry analyzer for<br>clinical use | I | 21 CFR 862.2160 | Chemistry (75) |

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Proprietary Names: RX Daytona Plus Chemistry Analyzer; RX Daytona Plus AST Reagent

## 4. PREDICATE DEVICE PROPRIETARY NAME AND 510 (k) NUMBER

Randox RX Imola Chemistry Analyzer with ISE Sodium, Potassium and Chloride electrodes K052914.

Randox AST assay K923505.

## 5. DEVICE DESCRIPTION

### RX Daytona plus system

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.

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## 6. TEST PRINCIPLE

#### RX Daytona plus system Operation

After a sample cup or patient tube is placed into the sample carousel, the analyser pipettes the sample into the cuvette, pipettes the reagent and mixes the sample and reagent together in the reaction cuvette. After the sample and reagent react the analyser measures the absorbance of the sample and based on the absorbance reactions for the analyte being measured, it calculates the concentration of the analyte in the sample. The test system can measure analytes from multiple matrices including serum and urine. The time to first result is approximately 13 minutes.

#### Test Principle for ISE Unit

### Measuring procedure, sodium, potassium and chloride:

ISE unit measures ionic concentration in sample with ion-selective electrode (ISE). It converts the activity of a specific ion dissolved in a solution into an electrical potential, according to the Nernst equation (below) Serum samples are measured by direct ISE method. Urine samples are prediluted with dedicated diluents and measured.

#### E=E0 + RT/nF x log a

- E: Sample potential
- E0 : Reference potential
- R : Gas constant
- T : Absolute temperature (K)
- n : lonic valance
- F : Faraday constant (C)
- a : lon activity

### Calculation of calibration slope

Slope is calculated according to the subtraction of H solution potential and L solution potential:

#### S = (EH-EL) / log (CH / CL)

- S : Slope (mV/decade) EH : H solution potential EL : L solution potential CH : H solution concentration CL : L solution concentration
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#### Measurement

Sample concentration is obtained by measuring sample potential and L solution potential and calculated according to the slope which is obtained through the calibration.

C = CL x 10 ^ { ( E - EL ) / S }

- C : Sample concentration
- CL: L solution concentration
- E : Sample potential
- EL . L solution potential
- S : Slope (mV/decade

### Process of analysis

- 1. Dispense sample into the sample port of the ISE module, with the sample probe (SPT).
- 2. Sample is delivered to electrodes.
- 3. Sample potential is measured.
- 4. Liquid in the flow path is wasted.
- 5. The flow path is cleaned with L solution.
- 6. L solution is delivered to electrodes.
- 7. L solution potential is measured.
- 8. Sample concentration is obtained by calculation according to sample potential and L solution potential.
- 9. Output the measurement result.

#### Test Principle for Chemistry Reactions

Randox AST Assay:

«-oxoglutarate reacts with L-aspartate in the presence of AST to form L-qlutamate plus oxaloacetate. The indicator reaction utilizes the oxaloacetate for a kinetic determination of NADH consumption.

> AST -oxoglutarate + → L-aspartate L-glutamate + oxaloacetate

MDH oxaloacetate + NADH + H* L-malate + NAD*

The ISE unit measures the concentration of Sodium (Na), Potassium (K) and Chloride (CI) contained in serum and urine by using ion specific electrodes.

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#### (510(K) Summary RX Daytona Plus Instrument NDIOF

## 7. INTENDED USE

The RX Daytona Plus Chemistry analyzer is a bench top fully automated ran d o m a c c s clinical chemistry analyzer intended for use in clinical laboratories. It is intended to be used for a variety of assay methods. The RX Davtona Plus includes an optional lon Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum and urineThe 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.

## 8. COMPARISON WITH PREDICATE

The following table describes the similarities and differences between the two systems.

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## Table 1 Technical Specification of the RX Daytona Plus and the RX Imola

| Parameter | RX Imola Automated Analyzer<br>(K052914) Predicate | RX Daytona Plus Automated<br>Analyser |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Furuno Electric Co. Ltd Japan on<br>behalf of Randox Laboratories | Same |
| Device<br>Classification | Chemistry Analyser<br>(Photometric, Discrete) for | Same |
| Analyzer<br>description: | High throughput, fully automated,<br>random access bench top<br>chemistry analyzer | Same |
| Dimensions | 970mm (W) x 690mm (D) x 580mm<br>(H) | 870mm (W) ×670mm (D) ×625mm<br>(H) |
| Intended use: | An In vitro fully quantitative<br>analyzer. The analyzer can be<br>used to run tests including AST in<br>serum samples. Various other<br>assays are adaptable to the<br>analyzer. The RX Imola analyzer<br>and ISE unit must only be used by<br>suitably qualified personnel, under<br>appropriate laboratory conditions. | Same |
| Assay Tests | Endpoint, Kinetic,<br>Bichromatic, turbidmetric,<br>sample blanking, reagent<br>blanking and ISE. | Monochromatic, bi-chromatic,<br>endpoint, kinetic, sample and reagent<br>blanking and ISE (via optional<br>integrated ISE) |
| Calibration<br>Principle | Factor, Linear, 2 point, point to<br>point, spline, log-logit,<br>exponential and ISE | Factor, Linear, Point to point, Log-<br>logit, Exponential, Spline, Spline 2<br>and ISE |
| Cuvettes | 90 reusable pyrex cuvettes<br>(volume, 150ul min, 450ul max) | 72 resin cuvettes (semi-disposable)<br>(volume, 100ul min, 350ul max) |
| Cycle Time | 9 seconds | 13 seconds |
| Detection<br>Principle | 12 wavelengths generated via<br>diffraction grating: 340, 380,<br>415,<br>450,510,546,570,600,660,700,750 | Same |
| Detector Method | Direct absorbance in cuvette<br>(bichromatic and monochromatic) | Same |
| Data Management | Storage of up to 10, 000<br>patient reports, search<br>facility | Storage of up to 30, 000 reports,<br>search facility |
| Parameter | RX Imola Automated<br>Analyzer | RX Daytona Plus Automated<br>Analyser |
| Light Source | Halogen Tungsten Lamp | Same |
| LIMS<br>Connectivity | Bi-directional; ASTM<br>Standard | Same |
| Maintenance | Daily maintenance-less<br>than<br>5minutes. No rear access<br>required. Simple twice yearly | Same |
| Analysis<br>method: | Photometr<br>ic | Same |
| Sample type: | Serum, urine | Same |
| Sample<br>Addition | Sampling interruption for addition<br>of samples | Same |
| Sample Volume | Normal Sample: 2-35µl | Normal Sample: 1.5-35µl |
| Sample<br>Capacity | Removable tray with 72 positions<br>for samples in outer ring, 20<br>positions for calibrators and<br>controls in the inner ring. | Removable tray with 40 positions for<br>samples in outer ring, 10 positions for<br>calibrators and controls in the inner<br>ring. |
| Sample<br>Dilution | Pre-diluted and automatic re-<br>assay with diluted, reduced and<br>increased sample volume | Same |
| Sample<br>Identification | Barcode sample identification | Same |
| Sample Pipette | Dedicated sample micropipette<br>with liquid level sensor, crash<br>protection and clot detection | Same |
| Sample Dead<br>Volume | 100ul in standard or primary<br>tubes, | Same |
| Sample Tube<br>Size | Multiple primary tube<br>sizes(diameter<br>12 to 16mm, height 55 to | Same |
| Reagent<br>Capacity | Removable tray with 60<br>cooled positions | Removable tray with 50 cooled<br>positions |
| Reagent<br>Cooling | 8- | Same |
| Reagent<br>Identification | Automatic barcode<br>reagent | Same |
| Reagent<br>Inventory | Calculation of remaining<br>reagent volume and tests<br>available. Alerts for shortage, | Same |

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## Table 1 Technical Specification of the RX Daytona Plus and the RX Imola Cont..

.

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| Table 1 Technical Specification of the RX Daytona Plus and the RX Imola Cont |
|------------------------------------------------------------------------------|
|------------------------------------------------------------------------------|

| Parameter | RX Imola Automated Analyzer<br>(K052914) Predicate | RX Daytona Plus Automated<br>Analyser |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent<br>pipette | Two Dedicated reagent<br>micropipette with liquid level<br>sensor and crash detection. Rinsed<br>inside and outside with purified | One Dedicated reagent micropipette<br>with liquid level sensor and crash<br>detection. Rinsed inside and outside<br>with purified water |
| Reagent<br>pipette<br>Sampling<br>Volume | R1:20-350ul (1ul increments)<br>R2: 20-2501ul (1ul<br>increments) | R1:20-250ul (1ul increments)<br>R2: 20-180ul (1ul increments) |
| Minimum reaction<br>volume | 150ul | 100ul |
| Maximum<br>Humidity | 45-85% without condensation | 45-85% without condensation |
| Incubation<br>Temperature | 37°C +/-0.3 | 37°C +/-0.1 |
| Stirring System | Stick type rotating stirrer with<br>variable speed to promote<br>even mixing in all types of | Same |
| Stirring Speed | Dual 5 speed rotating stirrers | 5 speed levels available |
| STAT sampling | STAT samples can be added<br>immediately via emergency<br>loading port | Same |
| Throughput | Capable of running 400 tests per<br>hour, 560 tests per hour with | Capable of running 270 tests per hour,<br>450 tests per hour with ISE |
| Test Channels | 60 photometric channels, 3 direct<br>ISE (Total 63 channels) | 50 photometric channels, 3 direct ISE<br>(Total 53 channels) |
| Water<br>Consumption | Maximum 18L per hour | Maximum 5L per hour |
| Parameter | RX Imola Automated<br>Analyzer<br>(K052914 | RX Daytona Plus Automated<br>Analyzer ISE Module |
| Sample | Serum, or<br>Urine<br>(Urine: automatic 10 fold dilution | Serum or Urine<br>(Urine: automatic 7 times dilution) |
| Sample size | 10ul Serum, (70ulx3) + 50ul Urine | 50ul |
| Reproducibility | | |
| Na K<br>Cl | Serum (Within<br>Run) :<br>CV <1.5%(100-<br>160mmol/L) CV <2% (3.0-<br>6.0mmol/L) CV <1.5% (80-<br>120mmol/L) | Serum (Within Run)<br>CV <1.0% (120-160mmol/L)<br>CV <1.5% (2-6mmol/L)<br>CV <1.2% (80-120mmol/L) |
| Na K<br>Cl | Urine (Within Run) CV<br><5% (20-500mmol/L) | Urine (Within Run)<br>CV <3.8% (80-200mmol/L)<br>CV <3.8% (20-150mmol/L) |
| Na K<br>Cl | CV <5% (1-500<br>mm ol/L) CV <5% (20-<br>500mmol/L) | CV <3.8% (70-140mmol/L) |
| | Serum (Between days)<br>CV <2.0%(100- | Serum (Between Days)<br>CV <2.0% (140mmol/L)<br>CV <2.0% (5mmol/L)<br>CV <2.0% (100mmol/L) |
| Analysis Time | Serum:30 seconds<br>Urine 100 seconds | Serum 36 seconds<br>Urine 54 seconds |
| Throughput | Serum 240 tests per<br>hour,<br>80 samples per<br>hour | Serum 300 tests per hour<br>Urine 200 tests per hour |
| Max<br>Temperature | 37°C | Same |
| Calibration<br>Frequency | 24 hours (main calibration) After ISE<br>cleaning, | Same |
| Reagents<br>required | Calibrator A (Cal A<br>bag) Calibrator B<br>Cleaning<br>solution | L Solution<br>H solution<br>ISE Cleaning solution Etching<br>solution (Na cleaning) Urine<br>Diluent |
| Parameter | RX Imola Automated Analyzer<br>(K052914) | RX Daytona Plus Automated<br>Analyzer ISE Module |
| Intended<br>use | CAL A and CAL B are used in the calibration<br>of sodium, potassium and chloride on the RX<br>Imola ISE module - | ISE Calibrators are used for the calibration of<br>sodium (Na+), potassium (K+) and chloride<br>(CI-) on the RX Daytona Plus analyzer<br>equipped with ISE module. |
| Analyte | Sodium , Potassium , Chloride | Same:<br>Sodium , Potassium , Chloride |
| Composition | Aqueous solution containing sodium,<br>potassium and chloride at two different levels<br>of concentration.<br>CAL A<br>Na+ = 140mmol/l<br>K+ = 4mmol/l<br>Cl- = 125 mmol/l<br>CAL B<br>Na+ = 70mmol/l<br>K+ = 8mmol/l<br>Cl- = 41 mmol/l | Aqueous solution containing sodium,<br>potassium and chloride at two different levels<br>of concentration.<br>L Solution Na+ =<br>120mmol/l K+ =<br>4mmol/l<br>Cl- = 100 mmol/l<br>H Solution Na+<br>= 200mmol/l K+ =<br>7mmol/l<br>Cl- = 150 mmol/l |
| Form | Liquid ready to use | Same |
| Storage<br>(opened) | Once opened CAL A is stable for 2 months<br>onboard the analyzer.<br>CAL B is stable for 1 month when stored at<br>+15 to +25°C | Once opened L Solution and H Solution are<br>stable for 1 month at +15 to +25°C |
| Storage<br>(Unopened) | Stable to the expiration date at +15 to +25°C | Stable to the expiration date at +15 to +25°C |

The RX Daytona Plus analyzer has the same intended use as the predicate device. Any differences in the technical characteristics of the RX Daytona Plus and the predicate device do not affect the safety or effectiveness. Therefore, the RX Daytona Plus analyzer demonstrates substantial equivalence to the predicate device

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## Table 2 Technical Specifications of the RX Daytona Plus ISE Module and the RX Imola Analyzer ISE Module

The RX Daytona Plus analyzer ISE unit has the same intended use as the predicate device. Any differences in the technical characteristics of the RX Daytona Plus ISE unit and the predicate device do not affect the safety or effectiveness. Therefore, the RX Daytona Plus analyzer ISE unit demonstrates substantial equivalence to the predicate device.

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## Table 3 Technical Specifications of the RX Daytona Plus ISE Calibrators and the RX Imola Analyzer ISE Calibrators

The RX Daytona Plus analyzer ISE Calibrators have the same intended use as the predicate device. Any differences in the technical characteristics of the RX Daytona Plus ISE Calibrators and the predicate device do not affect the safety or effectiveness. Therefore, the RX Daytona Plus analyzer ISE Calibrators demonstrates substantial equivalence to the predicate device.

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## Table 4 Technical Specifications of the AST predicate device with AST on the RX Daytona plus Analyzer ISE Module.

| CHARACTERISTICS | RANDOX AST REAGENT<br>ON THE RX IMOLA<br>ANALYZER K052914/A001 | RX Daytona Plus AST<br>REAGENT |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Intended Use | The AST test system is a device<br>intended for the quantitative in<br>vitro determination of aspartate<br>aminotransferase (AST) activity in<br>serum and plasma.<br>Measurements of AST are used<br>in the diagnosis and treatment of<br>certain types of liver and heart<br>disease | Same |
| Assay Protocol | UV Method | Same |
| Format | Liquid which are ready to use | Same |
| Storage<br>(unopened) | Reagents are stable up to the<br>expiry date when stored<br>unopened at +2 to +8°C | Same |
| Sample Type | Plasma and serum | Serum<br>only |
| Control Frequency | Randox assayed human<br>multisera Level 2 & 3<br>Two levels of control should be<br>assayed at least once a day | Same |
| Calibration Frequency | Every 28 days, with a change of<br>reagent lot or as indicated by<br>quality control procedures. | Same |
| Materials required but not<br>provided | Randox assayed human<br>multisera Level 2 & 3. Randox<br>Calibration Sera level 3. RX<br>Series Saline. | Same |

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## 9. PERFORMANCE CHARACTERISTICS

## Analytical performance:

#### a. Precision/Reproducibility:

Precision was evaluated consistent with C.L.S.I documents EP5 Precision studies were performed on one RX Daytona plus system using two levels of control material, calibration material, unaltered human serum samples and altered human serum samples for AST. Sodium, Potassium and Chloride. Urine precision studies were performed for Sodium, Potassium and Chloride using two levels of urine controls and two urine patient pools. Testing was conducted twice per day for 20 non consecutive days. Two replicates per run was performed for each sample. The results are summarized in the tables below:

## Table 2 AST Precision Summary

| System: RX Daytona Plus | | | Within Run | | Among Run | | Among Day | | Total | |
|-------------------------|--------------------------|---------------|------------|-----|-----------|-----|-----------|-----|-------|------|
| Method | Product | MEAN<br>(U/L) | SD | CV | SD | CV | SD | CV | SD | CV |
| AST | Control<br>538UE | 161.74 | 2.23 | 1.4 | 1.08 | 0.7 | 1.03 | 0.6 | 2.69 | 1.7 |
| AST | Control<br>738UN | 37.83 | 1.14 | 3.0 | 0.62 | 1.6 | 0.00 | 0.0 | 1.29 | 3.4 |
| AST | Calibrator<br>(532UE) | 142.95 | 1.82 | 1.3 | 1.25 | 0.9 | 0.04 | 0.0 | 2.20 | 1.5 |
| AST | HIGH<br>Serum<br>Pool | 391.33 | 2.26 | 0.6 | 5.16 | 1.3 | 7.61 | 1.9 | 9.47 | 2.4 |
| AST | NORMAL<br>Serum<br>Pool | 18.83 | 0.43 | 2.3 | 0.70 | 3.7 | 0.71 | 3.8 | 1.08 | 5.8 |
| AST | 850 u/L<br>Serum<br>Pool | 850.27 | 4.57 | 0.5 | 6.75 | 0.8 | 8.29 | 1.0 | 11.62 | 1.4 |
| AST | LOW<br>Serum<br>Pool | 6.68 | 0.53 | 8.0 | 0.49 | 7.3 | 0.37 | 5.6 | 0.81 | 12.2 |

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| System: RX Daytona Plus | | | Within Run | | Among Run | | Among Day | | Total | |
|-------------------------|-------------------|-------------------|------------|-----|-----------|-----|-----------|-----|-------|-----|
| Method | Product | MEAN<br>(mmol/l)) | SD | CV | SD | CV | SD | CV | SD | CV |
| Sodium | Control<br>538UE | 154.03 | 2.15 | 1.4 | 3.04 | 2.0 | 0.00 | 0.0 | 3.72 | 2.4 |
| Sodium | Control<br>738UN | 138.75 | 1.60 | 1.2 | 4.01 | 2.9 | 0.00 | 0.0 | 4.32 | 3.1 |
| Sodium | Patient<br>Pool 1 | 108.83 | 1.75 | 1.6 | 0.00 | 0.0 | 0.59 | 0.5 | 1.85 | 1.7 |
| Sodium | Patient<br>Pool 2 | 134.62 | 1.40 | 1.0 | 0.00 | 0.0 | 0.43 | 0.3 | 1.46 | 1.1 |
| Sodium | Patient<br>Pool 3 | 174.60 | 2.08 | 1.2 | 1.11 | 0.6 | 1.68 | 1.0 | 2.90 | 1.7 |

## Table 3 Sodium Serum Precision Summary

## Table 4 Sodium Urine Precision Summary

| System: RX Daytona Plus | | | Within Run | | Among Run | | Among Day | | Total | |
|-------------------------|-------------------|-------------------|------------|-----|-----------|-----|-----------|-----|-------|-----|
| Method | Product | MEAN<br>(mmol/l)) | SD | CV | SD | CV | SD | CV | SD | CV |
| Sodium | Control<br>575UC | 61.84 | 2.59 | 4.2 | 2.12 | 3.4 | 0.80 | 1.3 | 3.44 | 5.6 |
| Sodium | Control<br>580UC | 192.25 | 6.21 | 3.2 | 3.77 | 2.0 | 5.87 | 3.1 | 9.34 | 4.9 |
| Sodium | Patient<br>Pool 1 | 135.65 | 4.05 | 3.0 | 2.65 | 2.0 | 5.75 | 4.2 | 7.51 | 5.5 |
| Sodium | Patient<br>Pool 2 | 281.59 | 5.37 | 1.9 | 6.58 | 2.3 | 8.50 | 3.0 | 12.02 | 4.3 |

:

## Table 5 Potassium Serum Precision Summary

.

| System: RX Daytona Plus | | | Within Run | | Among Run | | Among Day | | Total | |
|-------------------------|-------------------|------------------|------------|-----|-----------|-----|-----------|-----|-------|-----|
| Method | Product | MEAN<br>(mmol/l) | SD | CV | SD | CV | SD | CV | SD | CV |
| Potassium | Control<br>538UE | 6.01 | 0.06 | 1.1 | 0.04 | 0.7 | 0.02 | 0.3 | 0.08 | 1.3 |
| Potassium | Control<br>738UN | 4.01 | 0.06 | 1.4 | 0.03 | 0.7 | 0.02 | 0.6 | 0.07 | 1.7 |
| Potassium | Patient<br>Pool 1 | 3.28 | 0.13 | 3.9 | 0.00 | 0.0 | 0.02 | 0.8 | 0.13 | 3.9 |
| Potassium | Patient<br>Pool 2 | 4.62 | 0.09 | 1.9 | 0.00 | 0.0 | 0.03 | 0.6 | 0.09 | 2.0 |
| Potassium | Patient<br>Pool 3 | 6.74 | 0.08 | 1.2 | 0.05 | 0.7 | 0.06 | 0.9 | 0.11 | 1.7 |

·

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| System: RX Daytona Plus | | | Within Run | | Among Run | | Among Day | | Total | |
|-------------------------|----------------|----------------|------------|-----|-----------|-----|-----------|-----|-------|-----|
| Method | Product | MEAN (mmol/l)) | SD | CV | SD | CV | SD | CV | SD | CV |
| Potassium | Control 575UC | 32.69 | 0.55 | 1.7 | 0.34 | 1.0 | 0.72 | 2.2 | 0.97 | 3.0 |
| Potassium | Control 580UC | 103.23 | 2.08 | 2.0 | 2.45 | 2.4 | 3.17 | 3.1 | 4.52 | 4.4 |
| Potassium | Patient Pool 1 | 31.86 | 0.57 | 1.8 | 0.46 | 1.4 | 0.47 | 1.5 | 0.87 | 2.7 |
| Potassium | Patient Pool 2 | 84.26 | 2.04 | 2.4 | 0.77 | 0.9 | 2.04 | 2.4 | 2.98 | 3.5 |

## Table 6 Potassium Urine Precision Summary

## Table 7 Chioride Serum Precision Summary

·

| System: RX Daytona Plus | | | Within Run | | Among Run | | Among Day | | Total | |
|-------------------------|-------------------|------------------|------------|-----|-----------|-----|-----------|-----|-------|-----|
| Method | Product | MEAN<br>(mmol/l) | SD | CV | SD | CV | SD | CV | SD | CV |
| Chloride | Control<br>538UE | 114.86 | 1.29 | 1.1 | 1.00 | 0.9 | 1.07 | 0.9 | 1.95 | 1.7 |
| Chloride | Control<br>738UN | 100.35 | 1.40 | 1.4 | 0.00 | 0.0 | 0.73 | 0.7 | 1.58 | 1.6 |
| Chloride | Patient<br>Pool 1 | 88.84 | 1.87 | 2.1 | 0.47 | 0.5 | 0.18 | 0.2 | 1.94 | 2.2 |
| Chloride | Patient<br>Pool 2 | 106.11 | 3.52 | 3.3 | 1.48 | 1.4 | 0.00 | 0.0 | 3.81 | 3.6 |
| Chloride | Patient<br>Pool 3 | 134.13 | 1.75 | 1.3 | 1.75 | 1.3 | 0.26 | 0.2 | 2.49 | 1.9 |

## Table 8 Chloride Urine Precision Summary

11. 11. 11.

.

| System: RX Daytona Plus | | MEAN (mmol/l)) | Within Run | | Among Run | | Among Day | | Total | |
|-------------------------|----------------|----------------|------------|-----|-----------|-----|-----------|-----|-------|-----|
| Method | Product | | SD | CV | SD | CV | SD | CV | SD | CV |
| Chloride | Control 575UC | 86.44 | 3.15 | 3.6 | 2.70 | 3.1 | 2.12 | 2.5 | 4.66 | 5.4 |
| Chloride | Control 580UC | 240.25 | 5.23 | 2.2 | 4.38 | 1.8 | 13.41 | 5.6 | 15.04 | 6.3 |
| Chloride | Patient Pool 1 | 171.06 | 4.98 | 2.9 | 5.34 | 3.1 | 0.00 | 0.0 | 7.30 | 4.3 |
| Chloride | Patient Pool 2 | 260.24 | 3.74 | 1.4 | 5.61 | 2.2 | 3.82 | 1.5 | 7.75 | 3.0 |

・

{14}------------------------------------------------

## b. Linearity/assay reportable range:

Linearity studies have been carried out in accordance with C.L.S.I. standard EP6-A. Linearity studies were performed at 11 levels to determine the analytical range of an assay - that is the range where the reported result is a linear function to the analyte concentration (or where deviation from linearity is less than 5%).

The results are summarized in the following tables:

## Table 9 Serum Linearity Summary

| Analyte | Linear regression | Reportable Range |
|-----------|---------------------------|------------------|
| AST | $y=1.00x+0.65; R^2=1.000$ | 5 – 1116U/L |
| Sodium | $y=1.05x-5.45; R^2=0.999$ | 90 – 226 mmol/l |
| Potassium | $y=1.02x-0.13; R^2=0.999$ | 0.5 – 11 mmol/l |
| Chloride | $y=0.99x+1.14; R^2=0.998$ | 72 – 210 mmol/l |

### Table 10 Urine Linearity Summary

| Analyte | Linear regression | Reportable Range |
|-----------|---------------------------|------------------|
| Sodium | $y=0.95x+7.26; R^2=0.998$ | 45 – 318 mmol/l |
| Potassium | $y=1.03x-1.20; R^2=1.000$ | 1.5 – 168 mmol/l |
| Chloride | $y=0.96x+3.41;R^2=0.999$ | 61 – 319 mmol/l |

| Analyte | Serum Reportable<br>Range | Urine Reportable<br>Range | | | |
|-----------|---------------------------|---------------------------|--|--|--|
| Sodium | 90 - 226mmol/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 | | | |

{15}------------------------------------------------

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

See K955489 Calibrator and K942458 Control for AST and K052914 for ിട്ടല

### Table 11 Traceability Table Randox AST Reagent and ISE's Sodium, Potassium and Chloride

| Analyte | Reference Material | |
|-------------------------------------------|-------------------------------------------------------------------------------------------|--|
| AST | Standardized against primary calibrators traceable to AST<br>reference material JSCC TS01 | |
| ISE: Sodium,<br>Potassium<br>and Chloride | Standardized against primary calibrators prepared<br>gravimetrically from purified salts. | |

#### d. Detection limit:

Sensitivity studies have been carried out in accordance with C.L.S.I. guideline EP17-A 'Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline'. A Limit of Blank (L.o.B.), a Limit of Detection (L.o.D.) and a Limit of Quantification were performed on the RX Daytona Plus.

## AST

The Limit of Detection (LoD) for AST on the RX Daytona Plus is 1.372 U/L based on 360 determinations, with 1 blank and 2 low level samples.

The Limit of Blank (LoB) is 0.50 U/L.

The Limit of Quantitation (LoQ) is 5 U/L as determined by the lowest concentration at which precision and accuracy are still met. Acceptable criteria ≤20% accuracy and ≤20% imprecision.

{16}------------------------------------------------

## e. Analytical Specificity:

The effects of potential interferents were determined by calculating the mean value of the spiked interferent with the corresponding control solution.

Hemoglobin, Bilirubin, Triglycerides and Intralipid tested up to the following levels and were found not to interfere with the AST assay.

### Table 12 AST Interference Summary

| Interferent | AST @ 35 U/L |
|---------------|--------------|
| Hemoglobin | Interferes |
| Bilirubin (F) | 60 mg/dl |
| Bilirubin (C) | 60 mg/dl |
| Intralipid ® | 500 mg/dl |
| Triglycerides | 500 mg/dl |

The analytes below were tested in serum up to the following levels and were found not to interfere with Sodium, Potassium and Chloride:

## Table 13 ISE Sodium, Potassium and Chloride Serum Interference Summary

| | Concentration | | |
|---------------|------------------------|----------------------------|-------------------------|
| Interferent | Sodium @<br>125 mmol/l | Potassium @<br>2.95 mmol/l | Chloride @<br>90 mmol/l |
| Hemoglobin | 500 mg/dl | * Interferes | 750 mg/dl |
| Bilirubin (F) | 60 mg/dl | 60 mg/dl | 30 mg/dl |
| Bilirubin (C) | 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 |

* Use non-hemolyzed samples as significant hemolysis will elevate AST and potassium levels.

{17}------------------------------------------------

A panel of drugs causes no significant interferences up to the indicated concentrations except Thyiocyanate and Salicylic acid which causes artificially elevated Chloride concentrations and Bromide which causes artificially elevated Chloride and Potassium concentrations.

## Table 14 ISE Sodium, Potassium and Chloride Serum Exogenous Interference Summary

| Interfering<br>Substance | Concentration of<br>interferent spiked into<br>140 mmol/l Sodium | Concentration of<br>interferent spiked into<br>3.4 mmol/l Potassium | Concentration of<br>interferent spiked into<br>108 mmol/l Chloride |
|--------------------------|------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------|
| Bromide | 37.5mmol/L | Interference observed<br><9.38mmol/l | Interference observed<br><9.38mmol/l |
| Ascorbic<br>Acid | 342mmol/L | 342mmol/L | 342mmol/L |
| Thiocyanate | 6.88mmol/L | 6.88mmol/L | Interference observed<br><1.72mmol/l |
| Lithium | 3.2mmol/L | 3.2mmol/L | 3.2mmol/L |
| Salicylic<br>Acid | 4.34mmol/L | 4.34mmol/L | Interference observed<br><1.085mmol/l |

## Urine Summary

The analytes below were tested in urine up to the following levels and were found not to interfere with Sodium, Potassium, and Chloride.

## Table 15 ISE Sodium, Potassium and Chloride Urine Interference Summary

| | Concentration | | | |
|---------------|--------------------|-----------------------|-----------------------|--|
| Interferent | Sodium @ 80 mmol/l | Potassium @ 21 mmol/l | Chloride @ 261 mmol/l | |
| Hemoglobin | 500 mg/dl | 500 mg/dl | 750 mg/dl | |
| Bilirubin (F) | 60 mg/dl | 60 mg/dl | 30 mg/dl | |
| Bilirubin (C) | 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 | |

{18}------------------------------------------------

## f. Method comparison with predicate device:

Correlation studies were carried out in accordance with C.L.S.I. guideline EP9-A2 'Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second Edition'.

### AST:

92 serum patient samples spanning the range 5 to 817U/L were tested on the RX Daytona plus analyzer across 5 working days with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained:

Y = 1.03x + 2.33 Correlation coefficient of r = 0.999

#### Sodium: Serum

50 serum patient samples spanning the range 105 to 194mmol/l were tested on the RX Daytona plus analyzer across 5 working days with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained:

Y = 1.04x - 9.57 Correlation coefficient of r = 0.990

#### Sodium: Urine

42 urine patient samples spanning the range 54.9 to 288.5mmo/l were tested on the RX Daytona plus analyzer across 5 working days with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained:

Y = 1.01x - 7.99 Correlation coefficient of r = 0.996

{19}------------------------------------------------

### Potassium: Serum

56 serum patient samples spanning the range 0.75 to 9.58mmol/l were tested on the RX Daytona plus analyzer across 5 working days with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained:

Y = 1.02x = 0.13 Correlation coefficient of r = 0.997

#### Potassium Urine

43 urine patient samples spanning the range 10.63 to 145.06mmoll were tested on the RX Daytona plus analyzer across 5 working days with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained:

Y = 1.04x - 1.48 Correlation coefficient of r = 0.999

### Chloride: Serum

61 serum patient samples spanning the range 81.3 to 189.3mmol/l were tested on the RX Daytona plus analyzer across 5 working days with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained:

Y = 1.03x - 1.16 Correlation coefficient of r = 0.990

#### Chloride: Urine

44 urine patient samples spanning the range 74.05 to 287.2mmoll were tested on the RX Daytona plus analyzer across 5 working days with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained:

Y = 0.97x + 5.08 Correlation coefficient of r = 0.997

{20}------------------------------------------------

## 510(K) Summary RX Daytona Plus Instrument

## g. Expected values/Reference-range:

Referenced from literature

Reference intervals for the ISEs were verified using NCCLS C28-A2 guidelines. In a study, human serum from 30 normal donors were tested in singlicate on the RX daytona plus. The results obtained were ordered from lowest to highest before being examined for outliers using the Dixon test.

Upon confirmation there were no outliers, the values were compared to the quoted ranges for Sodium, Potassium and Chloride. Results of the study indicate that all values reported in the range for Healthy Individuals.

| Analyte | Serum | Urine |
|-----------------|-----------------------------------------|------------------|
| AST1 | Men-Up to 35 U/L;<br>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 |

1 Schumann 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.

2 Tietz 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.

It is recommended that each laboratory establish its own reference range to reflect the age, sex, diet and geographical location of the population.

### 10. CONCLUSION

Testing results indicate that the proposed devices (RX Daytona Plus analyzer and Daytona Plus AST reagent ) are safe and effective for the stated intended use and are substantially equivalent to the predicate devices.

{21}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 9, 2014

RANDOX LABORATORIES, LTD. DR. PAULINE ARMSTRONG, QA/RA MANAGER 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM BT29 4QY UK

Re: K131554

Trade/Device Name: RX Daytona Plus Chemistry Analyzer, RX Daytona Plus Aspartate Aminotransferase (AST) Reagent

Regulation Number: 21 CFR 862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system Regulatory Class: II Product Code: CIT, JGS, CEM, CGZ, JJE Dated: November 29, 2013 Received: November 30, 2013

Dear Ms. Armstrong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersted commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or to and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{22}------------------------------------------------

If you desire specific advice for your device on our labeling regulations (2) CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Sotsonet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.itm. Also, plaase note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its roll free number [phone] or (30.1) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{23}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

#### k131554

Device Name Daytona Plus Chemistry analyzer

Daytona Plus Aspartate Aminotransferase (AST) reagent

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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