(161 days)
No
The summary describes a standard automated clinical chemistry analyzer with software for data management and barcode identification. There is no mention of AI, ML, or any advanced analytical techniques that would suggest the use of these technologies. The performance studies focus on traditional analytical validation metrics like precision, linearity, and method comparison.
No.
Explanation: The device is an in vitro diagnostic (IVD) device used for measurement of electrolytes to aid in diagnosis and treatment. It does not directly provide therapy or treatment to the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device can be used "for use in diagnosis and treatment of electrolyte imbalance" and "For in vitro diagnostic use only."
No
The device description clearly states that the RX imola is an "automated clinical chemistry analyzer complete with dedicated analyzer software" and is "fitted with an Ion Selective Electrode (ISE) module". This indicates the device includes significant hardware components (the analyzer, ISE module, electrodes) in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Measurement of Analytes in Biological Samples: The device is used for the measurement of electrolytes (sodium, potassium, and chloride) in serum and urine, which are biological samples.
- Purpose of Measurement: The measurements are intended "for use in diagnosis and treatment of electrolyte imbalance," which is a diagnostic purpose.
- Device Description: The description confirms it's an "automated clinical chemistry analyzer" with an "Ion Selective Electrode (ISE) module" for the "quantitative in vitro diagnostic determination" of these analytes.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ISE Electrodes on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum and urine and for use in diagnosis and treatment of electrolyte imbalance.
For in vitro diagnostic use only.
Product codes
CEM, CGZ, JGS
Device Description
RX imola is an automated clinical chemistry analyzer complete with dedicated analyzer software. Software functions of the analyzer include the facility to interact with a host computer for direct download of test method selection details for individual samples. A barcode system is used for the rapid identification of patient samples, reagents and QC samples,
In addition, the RX imola is fitted with an Ion Selective Electrode (ISE) module that operates in conjunction with specific electrodes for the quantitative in vitro diagnostic determination of Sodium, Potassium and Chloride in serum and urine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
Precision/Reproducibility:
Study Type: Precision studies
Sample Size:
- Serum precision: Two levels of control material and at least five human serum samples for Sodium, Potassium and Chloride.
- Urine precision: Two levels of urine controls and at least five urine patient pools.
Data Source: Not specified, but human serum samples and urine patient pools were used.
Number of Runs: Testing was conducted twice per day for 20 non-consecutive days, with two replicates per run.
Key Results: The acceptance criteria for precision was met for serum and urine for all analytes (Sodium, Potassium and Chloride) on the RX imola with the modified ISE device.
Linearity/Assay Reportable Range:
Study Type: Linearity studies
Sample Size: 9 levels of linearity samples.
Data Source: Not specified.
Key Results: The results of the linearity studies support the claimed measuring ranges for serum and urine for all analytes (Sodium, Potassium and Chloride) on the RX imola with the modified ISE device.
Specificity/Interference:
Study Type: Evaluation of specificity/interference
Data Source: Normal serum and normal urine.
Key Results: Various analytes (Haemoglobin, Total Bilirubin, Conjugate Bilirubin, Triglycerides, Intralipid®, Bromide, Ascorbic Acid, Thiocyanate, Lithium, Salicylic Acid, Boric Acid, Ethanol, Gamma Globulin, Glucose, HSA) were tested and found not to interfere up to specified levels in serum and urine for Sodium, Potassium, and Chloride determination.
Method Comparison with Predicate Device:
Study Type: Correlation studies
Data Source:
- Serum: 105 patient serum samples for Sodium, 109 patient serum samples for Potassium, 104 patient serum samples for Chloride.
- Urine: 72 patient urine samples for Sodium, 84 patient urine samples for Potassium, 90 patient urine samples for Chloride.
Key Results: - Serum Sodium: Y = 1.06x - 8.4, R = 0.973
- Serum Potassium: Y = 1.02x - 0.09, R = 0.998
- Serum Chloride: Y = 1.03x - 6.59, R = 0.987
- Urine Sodium: Y = 0.92x + 6.43, R = 0.997
- Urine Potassium: Y = 1.03x = 1.02, R = 0.999
- Urine Chloride: Y = 0.89x + 18.49, R = 0.986
Conclusion: The method comparison confirmed the device is substantially equivalent to the unmodified device (cleared under K052914).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1600 Potassium test system.
(a)
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.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
September 8, 2023
Randox Laboratories Limited Karena Shaw Regulatory Affairs Manager 55 Diamond Road County Antrim, BT29 40Y United Kingdom
Re: K230890
Trade/Device Name: ISE Electrodes Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium Test System Regulatory Class: Class II Product Code: CEM, CGZ, JGS Dated: August 11, 2023 Received: August 11, 2023
Dear Karena Shaw:
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 interstate 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, Drug, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230890
Device Name ISE Electrodes
Indications for Use (Describe)
The ISE Electrodes on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum and urine and for use in diagnosis and treatment of electrolyte imbalance.
For in vitro diagnostic use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒Prescription Use (Part 21 CFR 801 Subpart D) | ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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SPECIAL 510(k) SUMMARY K230890
General Information
Name: Randox Laboratories Limited
55 Diamond Road, Crumlin, Address: County Antrim, BT29 4QY, United Kingdom.
Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Contact: Karena Shaw E-mail: karena.shaw@randox.com
Device Identification
Proprietary Names: ISE Electrodes
Table 1: Candidate Device Regulatory Summary
| Product
| Code | Regulation Name | Classification | Regulation Section | Panel |
|---|---|---|---|---|
| CEM | Electrode, Ion-Specific, | |||
| Potassium | II | 21 CFR 862.1600 | Clinical Chemistry | |
| (75) | ||||
| CGZ | Electrode, Ion-Specific, | |||
| Chloride | II | 21 CFR 862.1170 | Clinical Chemistry | |
| (75) | ||||
| JGS | Electrode, Ion-Specific, | |||
| Sodium | II | 21 CFR 862.1665 | Clinical Chemistry | |
| (75) |
Predicate Device:
Previously cleared unmodified device: RX imola (K052914)
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DEVICE DESCRIPTION
RX imola is an automated clinical chemistry analyzer complete with dedicated analyzer software. Software functions of the analyzer include the facility to interact with a host computer for direct download of test method selection details for individual samples. A barcode system is used for the rapid identification of patient samples, reagents and QC samples,
In addition, the RX imola is fitted with an Ion Selective Electrode (ISE) module that operates in conjunction with specific electrodes for the quantitative in vitro diagnostic determination of Sodium, Potassium and Chloride in serum and urine.
INTENDED USE
The ISE Electrodes on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum and urine and for use in diagnosis and treatment of electrolyte imbalance.
For in vitro diagnostic use only.
DESCRIPTION OF MODIFICATION TO EXISTING DEVICE
Following discontinuation of the original ISE unit, the RX imola instruments purchased will now be fitted with a new ISE electrodes for Sodium, Potassium & Chlorides. RX imola instruments fitted with the new ISE electrodes will be identified by an alternate serial number prefix (7255).
The new ISE unit being implemented through this Special 510(k) was previously cleared under K131554 for our RX DAYTONA PLUS CHEMISTRY ANALYZER. The data included in this Special 510(k) summary is based on a comparison of the original ISE electrodes used in conjunction with RX imola (K052914) and the new ISE electrodes that will now be used with the RX imola.
COMPARISON WITH PREDICATE DEVICE
The following table describes the similarities and differences between
- ISE device originally cleared with the RX imola through K052914 .
- Candidate ISE device with the RX imola analyser ●
Table 2: Comparison with predicate device
Similarities
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| Parameter | RX imola
Automated Analyzer
With previous ISE unit
(ORIGINALLY CLEARED DEVICE
K052914) | RX imola
Automated Analyzer
With New ISE Unit
(CANDIDATE DEVICE
K230890) |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used for measurement of the electrolytes
sodium, potassium and chloride in serum
and urine for diagnosis and treatment of
electrolyte imbalance | Used for measurement of the electrolytes
sodium, potassium and chloride in serum and
urine for diagnosis and treatment of
electrolyte imbalance |
| Method | Direct | Direct |
| Calibration
Frequency | 8 Hours | 8 Hours |
| ISE
Electrodes
Usage
[10 000
Samples] | REF: 360 Days
Na+: 360 Days
K+: 180 Days
Cl-: 90 Days | REF: 360 Days
Na+: 360 Days
K+: 180 Days
Cl-: 90 Days |
| ISE Sample
Types | Serum
Urine | Serum
Urine |
| Environmental
Operating
Temperature | 15°C to 30°C | 15°C to 30°C |
| Parameter | RX imola
Automated Analyzer
With previous ISE unit
(ORIGINALLY CLEARED DEVICE
K052914) | RX imola
Automated Analyzer
With New ISE Unit
(CANDIDATE DEVICE
K230890) |
| ISE
Throughput | 240 tests per hour | 180 tests per hour |
| Consumables | Medica: Reference Electrode | Horiba: Reference Electrode |
| | Medica: Sodium Electrode (Na+) | Horiba: Sodium Electrode (Na+) |
| | Medica: Potassium (K+) | Horiba: Potassium (K+) |
| | Medica: Chloride (Cl-) | Horiba: Chloride (Cl-) |
| | Medica: CAL A | Horiba: L-Solution |
| | Medica: CAL B (Calibrator) | Horiba: H-Solution (Calibrator) |
| | Medica: Clean Solution | Horiba: Clean Solution |
| | Medica: Urine Diluent (for urine ISE) | Horiba: Urine Diluent (for urine ISE) |
| | | Horiba: Etching Solution |
| | | Horiba: Ref-Solution |
| Sample
Volume | 70ul | 53ul |
| Calibration
Type | 2-Point
(CAL A + CAL B) | 2-Point
(L-solution + H-Solution) |
| Analysis Time | Serum - 30s including 1-point calibration
Urine - 60s including 1-point calibration | Serum - 36s including 1 point calibration
Urine - 54s including 1 point calibration |
| ISE Module
Size | 100mm (H) x 102mm (W) x 91 mm (D) | 175mm (H) x 205mm (W) x 95 mm (D) |
| Maximum
Environmental
Temperature
(Unopened
Storage) | 38°C | 45°C |
| Calibration
Pass Range | Na+ pass range (50 mV - 66 mV) | Na+ pass range (38 mV - 65 mV) |
| | K+ pass range (50 mV - 63 mV) | K+ pass range (37 mV - 67mV) |
| | Cl- pass range (40 mV - 59 mV) | Cl- pass range (28 mV - 53 mV) |
Differences
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ANALYTICAL PERFORMANCE:
Precision/Reproducibility:
Precision was evaluated consistent with C.L.S.I document EP05-A3 'Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline- Third Edition.' Serum precision studies were performed on two RX imola systems using two levels of control material and at least five human serum samples for Sodium, Potassium and Chloride. Urine precision studies were performed on the same two RX imola systems for Sodium, Potassium and Chloride using two levels of urine controls and at least five 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 3: Sodium Serum Precision Summary
| Control 1 | Control 2 | Serum Pool 1 | Serum Pool 2 | Serum Pool 3 | Serum Pool 4 | Serum Pool 5 | Serum Pool 6 | |
|---|---|---|---|---|---|---|---|---|
| Mean (mmol/l) | 143.72 | 160.93 | 101.68 | 111.00 | 118.67 | 136.38 | 162.38 | 192.10 |
| SD | 0.88 | 1.01 | 0.69 | 0.59 | 1.88 | 0.47 | 2.69 | 0.37 |
| CV (%) | 0.6 | 0.6 | 0.7 | 0.5 | 1.6 | 0.3 | 1.7 | 0.2 |
| n | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 |
Within run precision
Total precision
| Control 1 | Control 2 | Serum Pool 1 | Serum Pool 2 | Serum Pool 3 | Serum Pool 4 | Serum Pool 5 | Serum Pool 6 | |
|---|---|---|---|---|---|---|---|---|
| Mean (mmol/l) | 143.72 | 160.93 | 101.68 | 111.00 | 118.67 | 136.38 | 162.38 | 192.10 |
| SD | 1.57 | 2.17 | 2.11 | 1.39 | 2.37 | 1.63 | 3.61 | 3.71 |
| CV (%) | 1.1 | 1.4 | 2.1 | 1.3 | 2.0 | 1.2 | 2.2 | 1.9 |
| n | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 |
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Table 4: Potassium Serum Precision Summary
Within run precision
| | Control
1 | Control
2 | Serum
Pool 1 | Serum
Pool 2 | Serum
Pool 3 | Serum
Pool 4 | Serum
Pool 5 | Serum
Pool 6 |
|---------------|--------------|--------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|
| Mean (mmol/l) | 4.00 | 6.43 | 0.91 | 2.16 | 3.26 | 4.56 | 6.58 | 9.73 |
| SD | 0.02 | 0.04 | 0.02 | 0.01 | 0.01 | 0.03 | 0.04 | 0.05 |
| CV (%) | 0.6 | 0.7 | 1.9 | 0.4 | 0.4 | 0.8 | 0.6 | 0.5 |
| n | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 |
Total precision
| | Control
1 | Control
2 | Serum
Pool 1 | Serum
Pool 2 | Serum
Pool 3 | Serum
Pool 4 | Serum
Pool 5 | Serum
Pool 6 |
|---------------|--------------|--------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|
| Mean (mmol/l) | 4.00 | 6.43 | 0.91 | 2.16 | 3.26 | 4.56 | 6.58 | 9.73 |
| SD | 0.04 | 0.09 | 0.04 | 0.04 | 0.04 | 0.06 | 0.09 | 0.20 |
| CV (%) | 0.9 | 1.4 | 4.1 | 1.6 | 1.3 | 1.2 | 1.4 | 2.1 |
| n | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 |
Table 5: Chloride Serum Precision Summary
Within run precision
| | Control
1 | Control
2 | Serum
Pool 2 | Serum
Pool 3 | Serum
Pool 4 | Serum
Pool 5 |
|---------------|--------------|--------------|-----------------|-----------------|-----------------|-----------------|
| Mean (mmol/l) | 98.27 | 120.99 | 83.30 | 96.14 | 117.38 | 161.10 |
| SD | 0.68 | 0.95 | 0.79 | 0.94 | 0.50 | 0.74 |
| CV (%) | 0.7 | 0.8 | 1.0 | 1.0 | 0.4 | 0.5 |
| n | 80 | 80 | 80 | 80 | 80 | 80 |
Total precision
| | Control
1 | Control
2 | Serum
Pool 2 | Serum
Pool 3 | Serum
Pool 4 | Serum
Pool 5 |
|---------------|--------------|--------------|-----------------|-----------------|-----------------|-----------------|
| Mean (mmol/l) | 98.27 | 120.99 | 83.30 | 96.14 | 117.38 | 161.10 |
| SD | 1.04 | 1.54 | 1.85 | 1.02 | 1.06 | 3.55 |
| CV (%) | 1.1 | 1.3 | 2.2 | 1.1 | 0.9 | 2.2 |
| n | 80 | 80 | 80 | 80 | 80 | 80 |
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Table 6: Sodium Urine Precision Summary
Within run precision
| Control 1 | Control 2 | Urine Pool 2 | Urine Pool 3 | Urine Pool 4 | Urine Pool 5 | Urine Pool 6 | |
|---|---|---|---|---|---|---|---|
| Mean (mmol/l) | 65.45 | 215.33 | 84.72 | 118.01 | 179.59 | 257.99 | 285.71 |
| SD | 2.48 | 2.83 | 1.91 | 2.41 | 3.08 | 2.88 | 2.77 |
| CV (%) | 3.8 | 1.3 | 2.3 | 2.0 | 1.7 | 1.1 | 1.0 |
| n | 80 | 80 | 80 | 80 | 80 | 80 | 80 |
Total precision
| Control 1 | Control 2 | Urine Pool 2 | Urine Pool 3 | Urine Pool 4 | Urine Pool 5 | Urine Pool 6 | |
|---|---|---|---|---|---|---|---|
| Mean (mmol/l) | 65.45 | 215.33 | 84.72 | 118.01 | 179.59 | 257.99 | 285.71 |
| SD | 3.85 | 8.94 | 3.18 | 3.19 | 4.71 | 6.11 | 7.16 |
| CV (%) | 5.9 | 4.2 | 3.8 | 2.7 | 2.6 | 2.4 | 2.5 |
| n | 80 | 80 | 80 | 80 | 80 | 80 | 80 |
Table 7: Potassium Urine Precision Summary
Within run precision
| | Control
1 | Control
2 | Urine
Pool 2 | Urine
Pool 3 | Urine
Pool 4 | Urine
Pool 5 |
|---------------|--------------|--------------|-----------------|-----------------|-----------------|-----------------|
| Mean (mmol/l) | 34.49 | 144.18 | 33.54 | 85.89 | 122.59 | 160.81 |
| SD | 0.32 | 0.93 | 0.21 | 0.82 | 0.77 | 1.73 |
| CV (%) | 0.9 | 0.6 | 0.6 | 1.0 | 0.6 | 1.1 |
| n | 80 | 80 | 80 | 80 | 80 | 80 |
Total precision
| | Control
1 | Control
2 | Urine
Pool 2 | Urine
Pool 3 | Urine
Pool 4 | Urine
Pool 5 |
|---------------|--------------|--------------|-----------------|-----------------|-----------------|-----------------|
| Mean (mmol/l) | 34.49 | 144.18 | 33.54 | 85.89 | 122.59 | 160.81 |
| SD | 0.77 | 4.80 | 0.73 | 2.49 | 4.10 | 6.50 |
| CV (%) | 2.2 | 3.3 | 2.2 | 2.9 | 3.3 | 4.0 |
| n | 80 | 80 | 80 | 80 | 80 | 80 |
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Table 8: Chloride Urine Precision Summary
Within run precision
| | Control
1 | Control
2 | Urine
Pool 1 | Urine
Pool 2 | Urine
Pool 3 | Urine
Pool 4 | Urine
Pool 5 | Urine
Pool 6 |
|---------------|--------------|--------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|
| Mean (mmol/l) | 86.04 | 280.01 | 85.63 | 93.06 | 146.38 | 198.19 | 247.72 | 315.40 |
| SD | 2.28 | 2.68 | 1.91 | 2.13 | 2.19 | 2.41 | 2.69 | 4.24 |
| CV (%) | 2.7 | 1.0 | 2.2 | 2.3 | 1.5 | 1.2 | 1.1 | 1.3 |
| n | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 |
Total precision
| | Control
1 | Control
2 | Urine
Pool 1 | Urine
Pool 2 | Urine
Pool 3 | Urine
Pool 4 | Urine
Pool 5 | Urine
Pool 6 |
|---------------|--------------|--------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|
| Mean (mmol/l) | 86.04 | 280.01 | 85.63 | 93.06 | 146.38 | 198.19 | 247.72 | 315.40 |
| SD | 2.93 | 7.57 | 2.97 | 3.33 | 3.67 | 4.53 | 7.66 | 8.12 |
| CV (%) | 3.4 | 2.7 | 3.5 | 3.6 | 2.5 | 2.3 | 3.1 | 2.6 |
| n | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 |
Precision Conclusion
The acceptance criteria for precision was met for serum and urine for all analytes (Sodium, Potassium and Chloride) on the RX imola with the modified ISE device.
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Linearity/assay reportable range:
Linearity studies have been carried out in serum and urine in accordance with C.L.S.I. standard EP6-A 'Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline'. Linearity studies were performed at 9 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 linearity samples were prepared at 9 levels to cover the measuring intervals in the table below.
| Analyte | Specimen Type | Measuring Interval (mmol/L) |
|---|---|---|
| Sodium | Serum | 90 to 200 |
| Urine | 45 to 318 | |
| Potassium | Serum | 0.5 to 11 |
| Urine | 7 to 168 | |
| Chloride | Serum | 72 to 210 |
| Urine | 61 to 319 |
Table 9: Linearity Results Summary
Linearity Conclusion
The results of the linearity studies support the above claimed measuring ranges for serum and urine for all analytes (Sodium, Potassium and Chloride) on the RX imola with the modified ISE device.
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Specificity/Interference
Evaluation of specificity/interference was carried out in serum and urine in accordance with EP07 3rd Edition 'Interference Testing in Clinical Chemistry.' The analytes below were tested in serum up to the following levels and were found not to interfere with Sodium, Potassium and Chloride determination.
ISE Sodium, Potassium and Chloride Interference Summary (in Serum) The analytes below were added to normal serum and found not to interfere up to the following levels.
| Sodium - 130 mmol/l | Potassium - 3 mmol/l | Chloride - 90 mmol/l | |
|---|---|---|---|
| Haemoglobin | 1000 mg/dl | 126 mg/dl | 1000 mg/dl |
| Total Bilirubin | 60 mg/dl | 60 mg/dl | 60 mg/dl |
| Conjugate Bilirubin | 60 mg/dl | 60 mg/dl | 49.5 mg/dl |
| Triglycerides | 2000 mg/dl | 2000 mg/dl | 2000 mg/dl |
| IntralipidⓇ | 2000 mg/dl | 2000 mg/dl | 2000 mg/dl |
Table 10: Analytes Added to Normal Serum Level 1
Table 11: Analytes Added to Normal Serum Level 2
| Sodium - 150 mmol/l | Potassium - 5 mmol/l | Chloride - 110 mmol/l | |
|---|---|---|---|
| Haemoglobin | 1000 mg/dl | 205 mg/dl | 1000 mg/dl |
| Total Bilirubin | 60 mg/dl | 60 mg/dl | 60 mg/dl |
| Conjugate Bilirubin | 60 mg/dl | 60 mg/dl | 60 mg/dl |
| Triglycerides | 2000 mg/dl | 2000 mg/dl | 2000 mg/dl |
| Intralipid® | 2000 mg/dl | 2000 mg/dl | 2000 mg/dl |
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Image /page/13/Picture/1 description: The image shows the word "RANDOX" in green letters. The "O" in the word is replaced with a red circle. The letters are bold and sans-serif.
| Interfering
| Substance | Sodium 130 mmol/l | Potassium 3 mmol/l | Chloride 90 mmol/l |
|---|---|---|---|
| Bromide | 37.5 mmol/l | 37.5 mmol/l | 37.5 mmol/l |
| Ascorbic Acid | 341 umol/L | 341 umol/L | 341 umol/L |
| Thiocyanate | 6.88 mmol/l | 0.8 mmol/l | 1.12 mmol/l |
| Lithium | 3.2 mmol/l | 3.2 mmol/l | 3.2 mmol/l |
| Salicylic Acid | 4.3 mmol/l | 4.3 mmol/l | 4.3 mmol/l |
Table 12: Exogenous Interferences in Serum - Level 1
Table 13: Exogenous Interferences in Serum - Level 2
| Interfering
| Substance | Sodium 150 mmol/l | Potassium 5 mmol/l | Chloride 110 mmol/l |
|---|---|---|---|
| Bromide | 37.5 mmol/l | 37.5 mmol/l | 37.5 mmol/l |
| Ascorbic Acid | 341 µmol/L | 341 µmol/L | 341 µmol/L |
| Thiocyanate | 6.88 mmol/l | 0.85 mmol/l | 1.25 mmol/l |
| Lithium | 3.2 mmol/l | 3.2 mmol/l | 3.2 mmol/l |
| Salicylic Acid | 4.3 mmol/l | 4.3 mmol/l | 4.3 mmol/l |
ISE Sodium, Potassium and Chloride Urine Interference (in urine) summary
The analytes below were added to normal urine and found not to interfere up to the following levels.
Table 14: Analytes Added to Normal Urine Specificity/Interference Level 1
| Sodium 40 mmol/l | Potassium 25 mmol/l | Chloride 110 mmol/l | |
|---|---|---|---|
| Haemoglobin | 590 mg/dl | 765 mg/dl | 1000 mg/dl |
| Total Bilirubin | 17.4 mg/dl | 60 mg/dl | 60 mg/dl |
| Conjugate Bilirubin | 22 mg/dl | 60 mg/dl | 44.5 mg/dl |
| Triglycerides | 2000 mg/dl | 2000 mg/dl | 2000 mg/dl |
| Intralipid® | 810 mg/dl | 2000 mg/dl | 2000 mg/dl |
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Image /page/14/Picture/1 description: The image shows the word "RANDO" in green, with a red circle in place of the letter "O", followed by the letter "X" in green. The font is bold and sans-serif. The logo is likely for a company or organization named Randox.
| Sodium 220 mmol/l | Potassium 125 mmol/l | Chloride 250 mmol/l | |
|---|---|---|---|
| Haemoglobin | 1000 mg/dl | 1000 mg/dl | 1000 mg/dl |
| Total Bilirubin | 60 mg/dl | 60 mg/dl | 60 mg/dl |
| Conjugate Bilirubin | 60 mg/dl | 60 mg/dl | 60 mg/dl |
| Triglycerides | 2000 mg/dl | 2000 mg/dl | 2000 mg/dl |
| Intralipid® | 2000 mg/dl | 2000 mg/dl | 2000 mg/dl |
Table 15: Analytes Added to Normal Urine Specificity/Interference Level 2
Table 16: Exogenous Interferences in Urine - Level 1
| Interfering
| Substance | Sodium 40 mmol/l | Potassium 25 mmol/l | Chloride 110 mmol/l |
|---|---|---|---|
| Ascorbic Acid | 200 mg/dl | 200 mg/dl | 200 mg/dl |
| Boric Acid | 1000 mg/dl | 1000 mg/dl | 1000 mg/dl |
| Ethanol | 1000 mg/dl | 1000 mg/dl | 1000 mg/dl |
| Gamma | |||
| Globulin | 500 mg/dl | 500 mg/dl | 500 mg/dl |
| Glucose | 2000 mg/dl | 2000 mg/dl | 2000 mg/dl |
| HSA | 500 mg/dl | 500 mg/dl | 500 mg/dl |
Table 17: Exogenous Interferences Level 2 (Urine)
| Interfering
| Substance | Sodium 220 mmol/l | Potassium 125 mmol/l | Chloride 250 mmol/l |
|---|---|---|---|
| Ascorbic Acid | 200 mg/dl | 200 mg/dl | 200 mg/dl |
| Boric Acid | 1000 mg/dl | 1000 mg/dl | 1000 mg/dl |
| Ethanol | 1000 mg/dl | 1000 mg/dl | 1000 mg/dl |
| Gamma Globulin | 500 mg/dl | 500 mg/dl | 500 mg/dl |
| Glucose | 2000 mg/dl | 2000 mg/dl | 2000 mg/dl |
| HSA | 500 mg/dl | 500 mg/dl | 500 mg/dl |
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Method comparison with predicate device:
Correlation studies were carried out for serum and urine in accordance with C.L.S.I. guideline EP09c 'Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline- Third Edition'. A method comparison was conducted against the unmodified device (cleared under K052914) to confirm the device is substantially equivalent. Testing was conducted on two RX imola analysers, one RX imola analyser with the modified device, and the other RX imola analyser with the unmodified device.
Correlation (Serum)
Sodium
This method – RX imola new ISE unit (Y) was compared with method on the RX imola with previous ISE unit (X) and the following linear regression equation obtained: -
Y = 1.06x - 8.4
R = 0.973
105 patient serum samples were analysed spanning the range 111.7 to 195.8 mmol/l.
Potassium
This method – RX imola new ISE unit (Y) was compared with method on the RX imola with previous ISE unit (X) and the following linear regression equation obtained: -
Y = 1.02x - 0.09
R = 0.998
109 patient serum samples were analysed spanning the range 0.96 to 10.63 mmol/l.
Chloride
This method – RX imola new ISE unit (Y) was compared with method on the RX imola with previous ISE unit (X) and the following linear regression equation obtained: -
Y = 1.03x - 6.59
R = 0.987
104 patient serum samples were analysed spanning the range 86.2 to 196.2 mmol/l.
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Image /page/16/Picture/1 description: The image shows the word "RANDOXX" in green letters. The "O" in "RANDOXX" has a red dot in the center. The letters are bold and sans-serif.
Correlation (Urine)
Sodium
This method – RX imola new ISE unit (Y) was compared with method on the RX imola with previous ISE unit (X) and the following linear regression equation obtained: -
Y = 0.92x + 6.43
R = 0.997
72 patient urine samples were analysed spanning the range 49.4 to 298.6 mmol/l.
Potassium
This method – RX imola new ISE unit (Y) was compared with method on the RX imola with previous ISE unit (X) and the following linear regression equation obtained: -
Y = 1.03x = 1.02
R = 0.999
84 patient urine samples were analysed spanning the range 9.5 to 167.6 mmol/l.
Chloride
This method - RX imola new ISE unit (Y) was compared with method on the RX imola with previous ISE unit (X) and the following linear regression equation obtained: -
Y = 0.89x + 18.49
R = 0.986
90 patient urine samples were analysed spanning the range 84.8 - 226.8 mmol/l.
DESIGN CONTROL ACTIVITIES
The verification and validation of the device modification has been performed under design control. The design control activities were based on the risk analysis and acceptance criteria were set to maintain the performance and safety of the device. The verification and validation includes in-house studies of precision, method comparison, interferences and linearity.
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Image /page/17/Picture/1 description: The image shows the word "RANDO" in green letters, with a red circle in the middle of the letter "O". The letters are bold and sans-serif. The background is white.
RISK ANALYSIS
A Risk Analysis was performed to identify any new risks associated with the change in the ISE electrodes provided with the RX imola. Based on this and the testing the results indicate that the changes to the ISE unit on the RX imola are safe and effective for the stated intended use and are substantially equivalent to the previously approved device.
OVERALL CONCLUSION
The modified device is substantially equivalent to the unmodified device (cleared under K052914).