RX IMOLA

K052914 · Randox Laboratories, Ltd. · CEM · Mar 31, 2006 · Clinical Chemistry

Device Facts

• Record ID: K052914
• Device Name: RX IMOLA
• Applicant: Randox Laboratories, Ltd.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Mar 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

Intended Use

The RX Imola is a medium-sized desktop fully Automated Clinical Chemistry Analyzer complete with Ion Selective Electrode (ISE) Unit and dedicated analyzer software. An external PC operates the analyzer and results can be printed as required. The analyzer may be connected to a host computer, when required. The analyzer can be used to run tests such as magnesium in serum and plasma samples. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia. Various other clinical chemistry assays are adaptable to the analyzer. The ISE Unit on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum, plasma and urine and for use in diagnosis and treatment of electrolyte imbalance. The RX Imola analyzer must only be used by suitably qualified personnel, under appropriate laboratory conditions. For in vitro diagnostic use only.

Device Story

RX Imola is a fully automated, medium-sized desktop clinical chemistry analyzer; includes integrated Ion Selective Electrode (ISE) unit. Inputs: serum, plasma, or urine samples. Operation: external PC controls analyzer; performs clinical chemistry assays and electrolyte measurements. Output: quantitative test results; printed or transmitted to host computer. Usage: clinical laboratory environment; operated by qualified personnel. Benefit: assists in diagnosis/treatment of electrolyte imbalances and magnesium-related conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics of the clinical chemistry and ISE analytical systems.

Technological Characteristics

Desktop automated clinical chemistry analyzer; includes ISE unit for electrolyte measurement. Connectivity: external PC interface, host computer connectivity. Software-controlled operation. In vitro diagnostic use.

Indications for Use

Indicated for use by qualified laboratory personnel for the quantitative measurement of magnesium, sodium, potassium, and chloride in serum, plasma, and urine to aid in the diagnosis and treatment of electrolyte imbalances, hypomagnesaemia, and hypermagnesaemia.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Submission Summary (Full Text)

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

A. 510(k) Number:
k052914

B. Purpose for Submission:
New device

C. Measurand:
Potassium, Chloride, Sodium, and Magnesium

D. Type of Test:
Quantitative, Photometric and Ion-specific

E. Applicant:
RANDOX LABORATORIES, LTD.

F. Proprietary and Established Names:
RX Imola

G. Regulatory Information:

1. Regulation section:
21CFR §-862.1600-Potassium test system.
21CFR §-862.1170-Chloride test system.
21CFR §-862.1665-Sodium test system.
21CFR §-862.1495-Magnesium test system.
21CFR §-862.2160-Discrete photometric chemistry analyzer for clinical use.

2. Classification:
Class 2

3. Product code:
CEM - electrode, ion specific, potassium
CGZ - electrode, ion-specific, chloride
JGS - electrode, ion specific, sodium
JGJ - photometric method, magnesium
JJE - analyzer, chemistry (photometric, discrete), for clinical use

4. Panel:
Chemistry (75)

H. Intended Use:

1. Intended use(s):
The RX Imola is a medium-sized desktop fully Automated Clinical Chemistry

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Analyzer complete with Ion Selective Electrode (ISE) Unit and dedicated analyzer software. An external PC operates the analyzer and results can be printed as required. The analyzer may be connected to a host computer, when required.

The analyzer can be used to run tests such as magnesium in serum and plasma samples. Magnesium measurements are used in the diagnosis and treatment of hypomagnesaemia and hypermagnesaemia. Various other clinical chemistry assays are adaptable to the analyzer.

The ISE Unit on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum, plasma and urine and for use in diagnosis and treatment of electrolyte imbalance.

The RX Imola analyzer must only be used by suitably qualified personnel, under appropriate laboratory conditions.

For in vitro diagnostic use only.

2. Indication(s) for use:
See 1. above.

3. Special conditions for use statement(s):
For prescription use

4. Special instrument requirements:
RX Imola analyzer

I. Device Description:

The RX Imola contains an ISE module for the measurement of Potassium, Chloride, Sodium, cleared under k024014 and a wet chemistry module. The cleared Randox Magnesium assay k974606 is submitted for use on the RX Imola

The RX Imola is a bench-top fully automated random access clinical analyzer. The RX Imola has the capacity to perform up to 400 tests per hour plus ISEs, and offers primary tube sampling, on-board sample dilution and a cooled reagent compartment.

- Cuvette wash system
- Refrigerated sample carousel for on-board calibrators and QC material
- STAT facility
- Direct interface with hose computer
- Automatic re-run and pre-dilution functions

The RX imola™ uses dedicated software for easy access to all system facilities and functions. A color, graphic user interface guides through the operating functions and provides a comprehensive data management system.

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J. Substantial Equivalence Information:

1. Predicate device name(s):
Randox RX Daytona Analyzer with ISE
Randox Magnesium

2. Predicate 510(k) number(s):
k024014 and k974606 respectively

3. Comparison with predicate:

| Similarities and Differences Analyzer Only | | |
| --- | --- | --- |
| Item | Predicate | Device |
| Intended use | Same | Same |
| Assay types | End-point, kinetic, turbidimetric, ISE, sample and reagent blanking. | Same |
| Calibration types | Linear, Factor, 2 point, point to point, log-logit, spline and exponential | Same |
| Calibration system | Up to 7 calibrators, and pre-dilution facility | Same |
| Sample types | Serum, plasma, urine, CSF, and supernatant | Same |
| Throughput | 450 test per hour (180 photometric and 270 ISE) | 560 tests per hour (400 photometric and 240 ISE) |
| Software | External PC and Windows NT based user interface | Same |
| Reaction system | 45 reusable Pyrex cuvettes (500 ul max volume) | 90 reusable Pyrex cuvettes (500 ul max volume) |
| Stirring System | Stick type rotating stirrer with variable speed | Same |
| Sample input | 40 position routine, STAT and QC samples. Barcode ID, Pre-dilution and auto re-assay | Two concentric ring disks for sample cup: Outer ring 72, inner ring 20 positions for calibrators, controls and STATS. Barcode ID, Pre-dilution and auto re-assay. |
| Sample Pipette | Micropipette with level detector. Inside and outside water wash | Same |
| Sample volume | 2-35ul | Same |
| Reagent System | Onboard refrigeration, barcode ID, calculation of remaining reagents and tests. 40 reagent positions. | Onboard refrigeration, barcode ID, calculation of remaining reagents and tests. 60 reagent positions. |

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| Similarities and Differences Analyzer Only | | |
| --- | --- | --- |
| Item | Predicate | Device |
| Reagent Pipette | Micropipette with level detector. Inside and outside water wash | Same |
| Reagent volume | 20-400ul | R1 20-350ul
R2 20-250ul |
| Reaction system | Direct heating 37 C +/- 0.3 | Same |
| Wavelengths | 340, 380, 415, 510, 546, 570, 600, 700 nm | 340, 380, 415, 510, 546, 570, 600, 660, 700, 750, 800 nm |
| ISE | Optional | Standard |
| Electrode Type | Sodium, Potassium, Chloride and Reference | Same |
| ISE Throughput | Serum – 90 urine 36 per hour | Serum – 80 urine 32 per hour |
| ISE Sample size | 70ul serum (70ul x3)
50ul urine | Same |
| ISE calibration | Two point calibration | Same |

K. Standard/Guidance Document Referenced (if applicable):
None referenced

L. Test Principle:
Randox Magnesium Assay
Magnesium ions react with xylidyl blue in an alkaline medium to form a water soluble purple-red chelate, the color intensity of which is proportional to the concentration of magnesium in the sample. Calcium is excluded from the reaction by complexing with EGTA

The ISE unit measures the concentration of sodium (Na), potassium (K) and chloride (Cl) contained in serum, plasma, urine etc. by using ion specific electrodes. Urine must be diluted ten times before measurement.

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Precision studies were performed using control materials at three concentrations for serum and two concentrations for urine. Testing was conducted in duplicate for 11 days with two runs per day. The results are summarized in the tables below.

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Magnesium

| Within run precision (Serum) | | Level 1 | Level 2 | Level 3 | Total run precision (Serum) | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Mean (mg/dL) | 1.60 | 2.19 | 4.23 | Mean (mg/dL) | 1.60 | 2.19 | 4.23 | |
| SD | 0.024 | 0.049 | 0.049 | SD | 0.024 | 0.049 | 0.073 | |
| CV(%) | 1.6 | 1.7 | 1.2 | CV(%) | 2.2 | 2.2 | 1.6 | |
| n | 44 | 44 | 44 | N | 44 | 44 | 44 | |

Magnesium

| Within run precision (Urine) | Level 1 | Level 2 | Total run precision (Urine) | Level 1 | Level 2 |
| --- | --- | --- | --- | --- | --- |
| Mean (mg/dL) | 7.07 | 38.1 | Mean (mg/dL) | 7.07 | 38.1 |
| SD | 0.10 | 0.37 | SD | 0.10 | 1.19 |
| CV(%) | 1.2 | 1.0 | CV(%) | 1.5 | 3.1 |
| N | 44 | 44 | n | 44 | 44 |

Sodium

| Within run precision (serum) | Level 1 | Level 2 | Level 3 | Total run precision (serum) | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Mean (mmol/L) | 116.13 | 138.00 | 153.51 | Mean (mmol/L) | 116.13 | 138.00 | 153.51 |
| SD | 0.33 | 0.48 | 1.28 | SD | 0.79 | 1.18 | 1.93 |
| CV (%) | 0.3 | 0.3 | 0.8 | CV (%) | 0.7 | 0.9 | 1.3 |
| N | 42 | 44 | 42 | N | 42 | 44 | 42 |

Sodium

| Within run precision (urine) | | Level 1 | Level 2 |
| --- | --- | --- | --- |
| Mean (mmol/L) | 65.83 | 185.61 | |
| SD | 1.94 | 1.76 | |
| CV (%) | 2.9 | 0.9 | |
| N | 44 | 44 | |
| Total run precision (urine) | | Level 1 | Level 2 |
| --- | --- | --- | --- |
| Mean (mmol/L) | 65.83 | 185.61 | |
| SD | 2.73 | 5.37 | |
| CV (%) | 4.1 | 2.9 | |
| N | 44 | 44 | |

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Potassium

| Within run Precision (serum) | Level 1 | Level 2 | Level 3 | Total run precision (serum) | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Mean (mmol/L) | 3.05 | 4.02 | 5.96 | Mean (mmol/L) | 3.05 | 4.02 | 5.96 |
| SD | 0.01 | 0.02 | 0.03 | SD | 0.12 | 0.16 | 0.35 |
| CV (%) | 0.4 | 0.5 | 0.4 | CV (%) | 4.0 | 4.0 | 5.9 |
| N | 44 | 44 | 44 | N | 44 | 44 | 44 |

Potassium

| Within run precision (urine) | Level 1 | Level 2 | Total run precision (urine) | Level 1 | Level 2 |
| --- | --- | --- | --- | --- | --- |
| Mean (mmol/L) | 28.59 | 91.02 | Mean (mmol/L) | 28.59 | 91.02 |
| SD | 0.56 | 1.27 | SD | 2.12 | 3.26 |
| CV (%) | 2.0 | 1.4 | CV (%) | 7.4 | 3.6 |
| N | 40 | 40 | n | 40 | 40 |

Chloride

| Within run precision (serum) | | Level 1 | Level 2 | Level 3 | Total run precision (serum) | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Mean (mmol/L) | 86.03 | 97.34 | 115.04 | Mean (mmol/L) | 86.03 | 97.34 | 115.04 | |
| SD | 0.26 | 0.32 | 1.79 | SD | 1.72 | 1.32 | 2.06 | |
| CV (%) | 0.3 | 0.3 | 1.6 | CV (%) | 2.0 | 1.4 | 1.8 | |
| N | 44 | 44 | 43 | N | 44 | 44 | 43 | |

Chloride

| Within run precision (urine) | Level 1 | Level 2 | Total run precision (urine) | Level 1 | Level 2 |
| --- | --- | --- | --- | --- | --- |
| Mean (mmol/L) | 69.80 | 210.57 | Mean (mmol/L) | 69.80 | 210.57 |
| SD | 1.64 | 2.58 | SD | 4.05 | 6.79 |
| CV (%) | 2.3 | 1.2 | CV (%) | 5.8 | 3.2 |
| N | 44 | 44 | n | 44 | 44 |

b. Linearity/assay reportable range:
Linearity studies were performed to determine the analytical range of an assay – that is the range where the reported result is a linear function of the analyte concentration (or where deviation from linearity is less than 5%).

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The linearity samples were prepared at 9 levels. The sponsor used a range from 0 analyte concentration (or other reasonable bottom of range level) up to a high concentration approximately 10% greater than the upper level of linearity to be claimed for the method.

| Analyte | Linearity | |
| --- | --- | --- |
| | mg/dL | mmol/L |
| Magnesium (serum) | 6.02 | 3.30 |
| ISE Sodium (serum) | | 170 |
| ISE Potassium (serum) | | 11 |
| ISE Chloride (serum) | | 200 |
| | | |
| Magnesium (urine) | 60 | 25.0 |
| ISE Sodium (urine) | | 1100 |
| ISE Potassium (urine) | | 450 |
| ISE Chloride (urine) | | 1100 |

c. Traceability, Stability, Expected values (controls, calibrators, or methods): See k955489 calibrator and k942458 control for Mg and k024014 for ISE

d. Detection limit:

| Analyte | Limit of Detection | | Limit of Quantification | |
| --- | --- | --- | --- | --- |
| | mg/dL | Mmol/L | mg/dL | mmol/L |
| Magnesium (serum) | 0.05 | 0.02 | 0.435 | 0.18 |
| ISE Sodium (serum) | N/A* | N/A | | 28.4 |
| ISE Potassium (serum) | N/A | N/A | | 0.33 |
| ISE Chloride (serum) | N/A | N/A | | 54.45 |
| *N/A = Not Applicable | | | | |
| Magnesium (urine) | 0.05 | 0.02 | 1.80 | 0.74 |
| ISE Sodium (urine) | N/A | N/A | | 23.0 |
| ISE Potassium (urine) | N/A | N/A | | 5.87 |
| ISE Chloride (urine) | N/A | N/A | | 32.7 |

e. Analytical specificity:

The analytes below were tested in serum up to the following levels and were found not to interfere with magnesium:

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| | Low Pool | High Pool |
| --- | --- | --- |
| Hemoglobin | 250 mg/dL | 750 mg/dL |
| Free Bilirubin | 30 mg/dL | 30 mg/dL |
| Conjugate Bilirubin | 30 mg/dL | 30 mg/dL |
| Triglycerides | 1000 mg/dL | 1000 mg/dL |
| Intralipids® | 250 mg/dL | 250 mg/dL |

The analytes below were tested in urine up to the following levels and were found not to interfere with magnesium:

| | Low Pool | High Pool |
| --- | --- | --- |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Free Bilirubin | 30 mg/dL | 30 mg/dL |
| Conjugate Bilirubin | 30 mg/dL | 30 mg/dL |
| Triglycerides | 1000 mg/dL | 1000 mg/dL |
| Intralipids | 1000 mg/dL | 1000 mg/dL |

## ISE - Serum

Analytes were added to the normal serum and were found not to interfere with ISE up to the following levels:

| Sodium | Low Pool | High Pool |
| --- | --- | --- |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Free Bilirubin | 30 mg/dL | 30 mg/dL |
| Conjugated Bilirubin | 30 mg/dL | 30 mg/dL |
| Triglycerides | 500 mg/dL | 750 mg/dL |
| Intralipids | 500 mg/dL | 500 mg/dL |
| Potassium | Low Pool | High Pool |
| Hemoglobin | 0 mg/dL | 0 mg/dL |
| Free Bilirubin | 30 mg/dL | 30 mg/dL |
| Conjugated Bilirubin | 30 mg/dL | 30 mg/dL |
| Triglycerides | 1000 mg/dL | 1000 mg/dL |
| Intralipids | 500 mg/dL | 500 mg/dL |
| Chloride | Low Pool | High Pool |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Free Bilirubin | 30 mg/dL | 30 mg/dL |
| Conjugated Bilirubin | 30 mg/dL | 30 mg/dL |
| Triglycerides | 500 mg/dL | 500 mg/dL |
| Intralipids | 500 mg/dL | 500 mg/dL |

## Urine

Analytes were added to normal urine and were found not to interfere up to the following levels:

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| Sodium | Low Pool | High Pool |
| --- | --- | --- |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Free Bilirubin | 30 mg/dL | 30 mg/dL |
| Conjugated bilirubin | 30 mg/dL | 30 mg/dL |
| Triglycerides | 250 mg/dL | 750 mg/dL |
| Intralipids | 750 mg/dL | 1000 mg/dL |
| Potassium | Low Pool | High Pool |
| Hemoglobin | 0 mg/dL | 500 mg/dL |
| Free Bilirubin | 30 mg/dL | 30 mg/dL |
| Conjugated bilirubin | 30 mg/dL | 30 mg/dL |
| Triglycerides | 1000 mg/dL | 1000 mg/dL |
| Intralipids | 500 mg/dL | 1000 mg/dL |
| Chloride | Low Pool | High Pool |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Free Bilirubin | 30 mg/dL | 30 mg/dL |
| Conjugated bilirubin | 30 mg/dL | 30 mg/dL |
| Triglycerides | 500 mg/dL | 1000 mg/dL |
| Intralipids | 1000 mg/dL | 1000 mg/dL |

f. Assay cut-off: Not Applicable

2. Comparison studies:

a. Method comparison with predicate device:

Magnesium

This method (Y) was compared with another commercially available method. (X) 106 serum patient samples were analyzed spanning the range 0.7 to 7.6 mg/dL and the following linear regression equation was obtained:

$$
\mathrm {Y} = 1. 0 1 \mathrm {X} - 0. 0 9 \text { and a correlation coefficient of } \mathrm {r} = 0. 9 9 7.
$$

43 urine patient samples were analyzed spanning the range 2.2 to 58.1 mg/dL and the following linear regression equation was obtained:

$$
Y = 0. 9 8 X + 0. 4 1 \text { and a correlation coefficient of } r = 0. 9 9 7.
$$

Sodium

This method (Y) was compared with another commercially available method. (X) 62 serum patient samples were analyzed spanning the range 83.9 to 161.0 mmol/L and the following linear regression equation was obtained:

$$
Y = 0. 9 1 7 - 1 1. 2 4 \text { and a correlation coefficient of } r = 0. 9 8 2.
$$

41 urine patient samples were analyzed spanning the range 63.8 to 852.0 mmol/L and the following linear regression equation was obtained:

$$
Y = 1. 0 0 7 - 7. 0 3 \text { and a correlation coefficient of } r = 1. 0 0 0.
$$

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# Potassium

This method (Y) was compared to another commercially available test method. (X) 66 serum patient samples were analyzed spanning the range 2.4 to $15.2\mathrm{mmol / L}$ . and the following linear regression equation was obtained: $\mathrm{Y} = 0.96\mathrm{X} + 0.13$ and a correlation coefficient of $\mathrm{r} = 1.000$ .

42 urine patient samples were analysed spanning the range 36.8 to 450.6 mmol/L and the following linear regression equation was obtained: $\mathrm{Y} = 0.96\mathrm{X} + 3.55$ and a correlation coefficient of $\mathrm{r} = 0.999$ .

# Chloride

This method (Y) was compared to another commercially available test method. (X) 62 serum patient samples were analyzed spanning the range 57.3 to $188.9\mathrm{mmol / L}$ and the following linear regression equation was obtained: $\mathrm{Y} = 1.03\mathrm{X} - 0.87$ and a correlation coefficient of $\mathrm{r} = 0.995$ .

40 Urine patient samples were analyzed spanning the range 80.4 to 470.7 mmol/L and the following linear regression equation was obtained: $\mathrm{Y} = 0.96\mathrm{X} - 9.22$ and a correlation coefficient of $\mathrm{r} = 0.984$ .

# b. Matrix comparison:

Matrix method comparisons for all assays using both serum and lithium heparin plasma were conducted to determine whether method accuracy with lithium heparin plasma specimens are equivalent to serum results and that lithium heparin plasma does not interfere with either the method or the system.

Patient samples were drawn in matched pairs - one sample serum (y) and the second sample lithium heparin plasma (x). A minimum of 20 matched patient sample pairs were tested using only the method under evaluation.

| Analyte | Regression | r | (n) |
| --- | --- | --- | --- |
| Magnesium | y = 1.004x + 0.00 | 0.992 | 25 |
| ISE Sodium | y = 0.983x + 0.96 | 0.984 | 23 |
| ISE Potassium | y = 0.954x + 0.23 | 0.974 | 24 |
| ISE Chloride | y = 0.972x + 1.81 | 0.990 | 24 |

# 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: Referenced from literature

N. Instrument Name:
RX Imola Analyzer

O. System Descriptions:

1. Modes of Operation:
- Software Windows XP based
- Random access and STAT modes
- Test channels 63 channels (60 photometric channels, 3 ISEs)
- Assay types Endpoint, kinetic, turbidimetric, ISE, sample and reagent blanking
- Reagent system- 60 reagent positions. Barcode identification of reagents, calculation of remaining reagent volume and tests available.
- Integrated ISE unit
- Cuvette system - 90 reusable cuvettes (volume 150 uL min, 450 uL max)
- Detector - Direct absorbance in cuvette (mono or bi-chromatic). Filters for 340, 380, 415, 450, 510, 546, 570, 600, 660, 700, 750 and 800 nm

2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐

The applicant has provided software documentation typical for this device type which demonstrates the device was developed and is currently under good software lifecycle processes.

3. Specimen Identification:
Barcode ID

4. Specimen Sampling and Handling:
Blood collection tubes, Sample cups STATS, Pre-dilution and auto re-assay

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5. Calibration:
Linear, Factor, 2 point, point to point, log-logit, spline and exponential

6. Quality Control:
Quality Control database, with various QC analysis functions.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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

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