(224 days)
No
The summary describes a standard automated clinical chemistry analyzer with typical features and performance studies. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No.
The device is a chemistry analyzer used to measure certain substances in patient samples for diagnostic purposes, not to treat or cure a disease.
Yes
The intended use explicitly states, "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." and then details specific measurements (Sodium, Potassium, Chloride, AST) "used in the diagnosis and treatment of diseases." It also mentions "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." The term "in vitro diagnostic" directly indicates its diagnostic purpose.
No
The device description clearly outlines a physical bench-top analyzer with hardware components (ISE module, cuvette wash system, etc.) and associated reagents, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the RX Daytona Plus Chemistry analyzer is "intended for use in clinical laboratories" and is used for "quantitative in vitro diagnostic determination" of various analytes in human serum and urine.
- Device Description: The device is described as a "clinical analyser" that performs tests on biological samples (serum and urine).
- Reagents: The description includes details about the reagents used, which are specifically designed for performing diagnostic tests on biological samples.
- Performance Studies: The document details performance studies conducted to validate the analytical performance of the device for diagnostic purposes, including precision, linearity, sensitivity, and method comparison with a predicate device.
- Predicate Device: A predicate device (Randox RX Imola Chemistry Analyzer with ISE and Randox AST assay) is listed, which are also IVD devices.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
CIT, JGS, CEM, CGZ, JJE
Device Description
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 alpha-oxoglutarate/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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Serum, urine (for samples)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
AST Precision Summary:
Control 538UE (Mean 161.74 U/L): Total SD 2.69, Total CV 1.7%
Control 738UN (Mean 37.83 U/L): Total SD 1.29, Total CV 3.4%
Calibrator (532UE) (Mean 142.95 U/L): Total SD 2.20, Total CV 1.5%
HIGH Serum Pool (Mean 391.33 U/L): Total SD 9.47, Total CV 2.4%
NORMAL Serum Pool (Mean 18.83 U/L): Total SD 1.08, Total CV 5.8%
850 u/L Serum Pool (Mean 850.27 U/L): Total SD 11.62, Total CV 1.4%
LOW Serum Pool (Mean 6.68 U/L): Total SD 0.81, Total CV 12.2%
Sodium Serum Precision Summary:
Control 538UE (Mean 154.03 mmol/l)): Total SD 3.72, Total CV 2.4%
Control 738UN (Mean 138.75 mmol/l)): Total SD 4.32, Total CV 3.1%
Patient Pool 1 (Mean 108.83 mmol/l)): Total SD 1.85, Total CV 1.7%
Patient Pool 2 (Mean 134.62 mmol/l)): Total SD 1.46, Total CV 1.1%
Patient Pool 3 (Mean 174.60 mmol/l)): Total SD 2.90, Total CV 1.7%
Sodium Urine Precision Summary:
Control 575UC (Mean 61.84 mmol/l)): Total SD 3.44, Total CV 5.6%
Control 580UC (Mean 192.25 mmol/l)): Total SD 9.34, Total CV 4.9%
Patient Pool 1 (Mean 135.65 mmol/l)): Total SD 7.51, Total CV 5.5%
Patient Pool 2 (Mean 281.59 mmol/l)): Total SD 12.02, Total CV 4.3%
Potassium Serum Precision Summary:
Control 538UE (Mean 6.01 mmol/l): Total SD 0.08, Total CV 1.3%
Control 738UN (Mean 4.01 mmol/l): Total SD 0.07, Total CV 1.7%
Patient Pool 1 (Mean 3.28 mmol/l): Total SD 0.13, Total CV 3.9%
Patient Pool 2 (Mean 4.62 mmol/l): Total SD 0.09, Total CV 2.0%
Patient Pool 3 (Mean 6.74 mmol/l): Total SD 0.11, Total CV 1.7%
Potassium Urine Precision Summary:
Control 575UC (Mean 32.69 mmol/l)): Total SD 0.97, Total CV 3.0%
Control 580UC (Mean 103.23 mmol/l)): Total SD 4.52, Total CV 4.4%
Patient Pool 1 (Mean 31.86 mmol/l)): Total SD 0.87, Total CV 2.7%
Patient Pool 2 (Mean 84.26 mmol/l)): Total SD 2.98, Total CV 3.5%
Chloride Serum Precision Summary:
Control 538UE (Mean 114.86 mmol/l): Total SD 1.95, Total CV 1.7%
Control 738UN (Mean 100.35 mmol/l): Total SD 1.58, Total CV 1.6%
Patient Pool 1 (Mean 88.84 mmol/l): Total SD 1.94, Total CV 2.2%
Patient Pool 2 (Mean 106.11 mmol/l): Total SD 3.81, Total CV 3.6%
Patient Pool 3 (Mean 134.13 mmol/l): Total SD 2.49, Total CV 1.9%
Chloride Urine Precision Summary:
Control 575UC (Mean 86.44 mmol/l)): Total SD 4.66, Total CV 5.4%
Control 580UC (Mean 240.25 mmol/l)): Total SD 15.04, Total CV 6.3%
Patient Pool 1 (Mean 171.06 mmol/l)): Total SD 7.30, Total CV 4.3%
Patient Pool 2 (Mean 260.24 mmol/l)): Total SD 7.75, Total CV 3.0%
b. Linearity/assay reportable range:
Linearity studies carried out in accordance with C.L.S.I. standard EP6-A at 11 levels.
Serum Linearity Summary:
AST: y=1.00x+0.65; R^2=1.000; Reportable Range 5 – 1116 U/L
Sodium: y=1.05x-5.45; R^2=0.999; Reportable Range 90 – 226 mmol/l
Potassium: y=1.02x-0.13; R^2=0.999; Reportable Range 0.5 – 11 mmol/l
Chloride: y=0.99x+1.14; R^2=0.998; Reportable Range 72 – 210 mmol/l
Urine Linearity Summary:
Sodium: y=0.95x+7.26; R^2=0.998; Reportable Range 45 – 318 mmol/l
Potassium: y=1.03x-1.20; R^2=1.000; Reportable Range 1.5 – 168 mmol/l
Chloride: y=0.96x+3.41; R^2=0.999; Reportable Range 61 – 319 mmol/l
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
AST is standardized against primary calibrators traceable to AST reference material JSCC TS01.
ISE (Sodium, Potassium, Chloride) is standardized against primary calibrators prepared gravimetrically from purified salts.
d. Detection limit:
Sensitivity studies carried out in accordance with C.L.S.I. guideline EP17-A.
AST: Limit of Detection (LoD) = 1.372 U/L, Limit of Blank (LoB) = 0.50 U/L, Limit of Quantitation (LoQ) = 5 U/L.
e. Analytical Specificity:
Interference studies conducted for Hemoglobin, Bilirubin, Triglycerides, Intralipid for AST and ISE.
AST: Hemoglobin interferes. Bilirubin (F & C), Intralipid, Triglycerides found not to interfere up to indicated levels (60 mg/dl, 500 mg/dl, 500 mg/dl respectively).
ISE (Na, K, Cl) Serum: Hemoglobin interferes with Potassium; for Sodium and Chloride, Hemoglobin, Bilirubin (F & C), Intralipid, Triglycerides found not to interfere up to indicated levels. Bromide, Thiocyanate, and Salicylic acid cause analytically elevated Chloride concentrations. Bromide also causes elevated Potassium concentrations.
ISE (Na, K, Cl) Urine: Hemoglobin, Bilirubin (F & C), Intralipid, Triglycerides found not to interfere up to indicated levels.
f. Method comparison with predicate device:
Correlation studies carried out in accordance with C.L.S.I. guideline EP9-A2 using patient samples.
AST: 92 serum patient samples (range 5 to 817U/L), tested over 5 working days.
Linear regression: Y = 1.03x + 2.33
Correlation coefficient: r = 0.999
Sodium: Serum: 50 serum patient samples (range 105 to 194mmol/l), tested over 5 working days.
Linear regression: Y = 1.04x - 9.57
Correlation coefficient: r = 0.990
Sodium: Urine: 42 urine patient samples (range 54.9 to 288.5mmo/l), tested over 5 working days.
Linear regression: Y = 1.01x - 7.99
Correlation coefficient: r = 0.996
Potassium: Serum: 56 serum patient samples (range 0.75 to 9.58mmol/l), tested over 5 working days.
Linear regression: Y = 1.02x = 0.13
Correlation coefficient: r = 0.997
Potassium Urine: 43 urine patient samples (range 10.63 to 145.06mmoll), tested over 5 working days.
Linear regression: Y = 1.04x - 1.48
Correlation coefficient: r = 0.999
Chloride: Serum: 61 serum patient samples (range 81.3 to 189.3mmol/l), tested over 5 working days.
Linear regression: Y = 1.03x - 1.16
Correlation coefficient: r = 0.990
Chloride: Urine: 44 urine patient samples (range 74.05 to 287.2mmoll), tested over 5 working days.
Linear regression: Y = 0.97x + 5.08
Correlation coefficient: r = 0.997
g. Expected values/Reference-range:
Reference intervals for ISEs verified using NCCLS C28-A2 guidelines. Study with 30 normal donors showed values within quoted ranges.
Reference Ranges:
AST: Men-Up to 35 U/L; Women up to 31 U/L
Sodium (Na+): Serum 136-145 mmol/l; Urine 40-220 mmol/24h
Potassium (K+): Serum 3.5-5.1 mmol/l; Urine 25-125 mmol/24h
Chloride (Cl-): Serum 98-107 mmol/l; Urine 110-250 mmol/24h
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Contact: Dr Pauline Armstrong E-mail: Pauline.Armstrong@randox.com
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 | |||
| 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) |
1
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.
2
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
3
3
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
-
- Dispense sample into the sample port of the ISE module, with the sample probe (SPT).
-
- Sample is delivered to electrodes.
-
- Sample potential is measured.
-
- Liquid in the flow path is wasted.
-
- The flow path is cleaned with L solution.
-
- L solution is delivered to electrodes.
-
- L solution potential is measured.
-
- Sample concentration is obtained by calculation according to sample potential and L solution potential.
-
- 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.
4
(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.
5
Table 1 Technical Specification of the RX Daytona Plus and the RX Imola
| Parameter | RX Imola Automated Analyzer
(K052914) Predicate | RX Daytona Plus Automated
Analyser |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Furuno Electric Co. Ltd Japan on
behalf of Randox Laboratories | Same |
| Device
Classification | Chemistry Analyser
(Photometric, Discrete) for | Same |
| Analyzer
description: | High throughput, fully automated,
random access bench top
chemistry analyzer | Same |
| Dimensions | 970mm (W) x 690mm (D) x 580mm
(H) | 870mm (W) ×670mm (D) ×625mm
(H) |
| Intended use: | An In vitro fully quantitative
analyzer. The analyzer can be
used to run tests including AST in
serum samples. Various other
assays are adaptable to the
analyzer. The RX Imola analyzer
and ISE unit must only be used by
suitably qualified personnel, under
appropriate laboratory conditions. | Same |
| Assay Tests | Endpoint, Kinetic,
Bichromatic, turbidmetric,
sample blanking, reagent
blanking and ISE. | Monochromatic, bi-chromatic,
endpoint, kinetic, sample and reagent
blanking and ISE (via optional
integrated ISE) |
| Calibration
Principle | Factor, Linear, 2 point, point to
point, spline, log-logit,
exponential and ISE | Factor, Linear, Point to point, Log-
logit, Exponential, Spline, Spline 2
and ISE |
| Cuvettes | 90 reusable pyrex cuvettes
(volume, 150ul min, 450ul max) | 72 resin cuvettes (semi-disposable)
(volume, 100ul min, 350ul max) |
| Cycle Time | 9 seconds | 13 seconds |
| Detection
Principle | 12 wavelengths generated via
diffraction grating: 340, 380,
415,
450,510,546,570,600,660,700,750 | Same |
| Detector Method | Direct absorbance in cuvette
(bichromatic and monochromatic) | Same |
| Data Management | Storage of up to 10, 000
patient reports, search
facility | Storage of up to 30, 000 reports,
search facility |
| Parameter | RX Imola Automated
Analyzer | RX Daytona Plus Automated
Analyser |
| Light Source | Halogen Tungsten Lamp | Same |
| LIMS
Connectivity | Bi-directional; ASTM
Standard | Same |
| Maintenance | Daily maintenance-less
than
5minutes. No rear access
required. Simple twice yearly | Same |
| Analysis
method: | Photometr
ic | Same |
| Sample type: | Serum, urine | Same |
| Sample
Addition | Sampling interruption for addition
of samples | Same |
| Sample Volume | Normal Sample: 2-35µl | Normal Sample: 1.5-35µl |
| Sample
Capacity | Removable tray with 72 positions
for samples in outer ring, 20
positions for calibrators and
controls in the inner ring. | Removable tray with 40 positions for
samples in outer ring, 10 positions for
calibrators and controls in the inner
ring. |
| Sample
Dilution | Pre-diluted and automatic re-
assay with diluted, reduced and
increased sample volume | Same |
| Sample
Identification | Barcode sample identification | Same |
| Sample Pipette | Dedicated sample micropipette
with liquid level sensor, crash
protection and clot detection | Same |
| Sample Dead
Volume | 100ul in standard or primary
tubes, | Same |
| Sample Tube
Size | Multiple primary tube
sizes(diameter
12 to 16mm, height 55 to | Same |
| Reagent
Capacity | Removable tray with 60
cooled positions | Removable tray with 50 cooled
positions |
| Reagent
Cooling | 8- | Same |
| Reagent
Identification | Automatic barcode
reagent | Same |
| Reagent
Inventory | Calculation of remaining
reagent volume and tests
available. Alerts for shortage, | Same |
.
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Image /page/6/Picture/0 description: The image shows the text "RANDOX 510(K) Summary RX Daytona Plus Instrument". The text appears to be a title or heading, possibly related to a medical or scientific instrument. The text is black and the background is white. The text is left-aligned.
Table 1 Technical Specification of the RX Daytona Plus and the RX Imola Cont..
.
7
| Table 1 Technical Specification of the RX Daytona Plus and the RX Imola Cont |
|---|
| ------------------------------------------------------------------------------ |
| Parameter | RX Imola Automated Analyzer
(K052914) Predicate | RX Daytona Plus Automated
Analyser |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent
pipette | Two Dedicated reagent
micropipette with liquid level
sensor and crash detection. Rinsed
inside and outside with purified | One Dedicated reagent micropipette
with liquid level sensor and crash
detection. Rinsed inside and outside
with purified water |
| Reagent
pipette
Sampling
Volume | R1:20-350ul (1ul increments)
R2: 20-2501ul (1ul
increments) | R1:20-250ul (1ul increments)
R2: 20-180ul (1ul increments) |
| Minimum reaction
volume | 150ul | 100ul |
| Maximum
Humidity | 45-85% without condensation | 45-85% without condensation |
| Incubation
Temperature | 37°C +/-0.3 | 37°C +/-0.1 |
| Stirring System | Stick type rotating stirrer with
variable speed to promote
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
immediately via emergency
loading port | Same |
| Throughput | Capable of running 400 tests per
hour, 560 tests per hour with | Capable of running 270 tests per hour,
450 tests per hour with ISE |
| Test Channels | 60 photometric channels, 3 direct
ISE (Total 63 channels) | 50 photometric channels, 3 direct ISE
(Total 53 channels) |
| Water
Consumption | Maximum 18L per hour | Maximum 5L per hour |
| Parameter | RX Imola Automated
Analyzer
(K052914 | RX Daytona Plus Automated
Analyzer ISE Module |
| Sample | Serum, or
Urine
(Urine: automatic 10 fold dilution | Serum or Urine
(Urine: automatic 7 times dilution) |
| Sample size | 10ul Serum, (70ulx3) + 50ul Urine | 50ul |
| Reproducibility | | |
| Na K
Cl | Serum (Within
Run) :
CV