ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...
Device Facts
| Record ID | K102647 |
|---|---|
| Device Name | ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... |
| Applicant | Elitechgroup Vital Scientific BV |
| Product Code | JGS · Clinical Chemistry |
| Decision Date | Mar 24, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1665 |
| Device Class | Class 2 |
Intended Use
The ELITech Clinical system Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophotometric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidimetric assays. The second module is an electrometer used for measurement of electrolytes. For in vitro diagnostic use only.
Device Story
Selectra ProM is an automated, bench-top clinical chemistry analyzer for professional use in clinical laboratories. It utilizes two integrated modules: a photometric unit for end-point, rate, and turbidimetric assays, and an ion-selective electrode (ISE) module for electrometric measurement of sodium, potassium, and chloride. The device processes human serum or plasma samples. Operators load samples and reagents; the system performs automated analysis. Output is provided to healthcare providers to assist in diagnosing and monitoring liver disease, heart disease, and electrolyte imbalances. The system includes dedicated reagents (AST/GOT 4+1 SL), calibrators (ELICAL 2, ISE Calibrators), and controls (ELITROL I/II) to ensure accuracy and precision. The device benefits patients by providing rapid, reliable diagnostic data for clinical decision-making.
Clinical Evidence
No clinical trials were performed. Substantial equivalence is supported by bench testing, including method comparison studies (correlation with predicate), precision (within-run and total CVs), limit of detection/quantification, and interference studies (bilirubin, turbidity, ascorbic acid, etc.). Method comparison for AST showed y=1.028x - 0.16, r2=0.996. ISE module comparison showed high correlation (r=0.992-0.997) with predicate.
Technological Characteristics
Bench-top automated analyzer. Photometric unit for spectrophotometric assays; ISE module for Na+, K+, Cl- measurement via indirect potentiometry. Reagents are liquid, ready-to-use. Calibrators and controls are lyophilized human serum-based. Connectivity/software details not specified beyond automated operation. Sterilization not applicable; reagents contain sodium azide as preservative.
Indications for Use
Indicated for quantitative in vitro diagnostic determination of AST activity in human serum/plasma for liver/heart disease diagnosis; and quantitative determination of sodium, potassium, and chloride in human serum/plasma for diagnosis/treatment of electrolyte/metabolic disorders (e.g., aldosteronism, diabetes insipidus, hypertension, Addison's disease, dehydration, cystic fibrosis, diabetic acidosis). For central laboratory use only.
Regulatory Classification
Identification
A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Predicate Devices
- HORIBA ABX Pentra 400 (k052007)
- Roche cobas C111 (k071211)
- ABX PENTRA AST CP (k060318)
- Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k041227)
- Roche Diagnostics Precinorm U and Precipath U (k033501)
- Roche Standards for the Cobas ISE Module (k897071)
Related Devices
- K140690 — BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2, 2014
- K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR · Carolina Liquid Chemistries Corp. · May 16, 2014
Submission Summary (Full Text)
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## SECTION 5 - 510(k) Summary
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MAR 2 4 2011
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Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| The assigned 510(k) number is: | K102647 |
|--------------------------------|---------|
|--------------------------------|---------|
| Submitter | ELITech Vital Scientific BV |
|--------------|---------------------------------------------------------|
| Address | Van Rensselaerweg 4, 6956 AV SPANKEREN, The Netherlands |
| Phone number | + 31 (0) 313 430 501 |
| Fax number | + 33 (0) 313 427 807 |
| Contact | Colinda van den Broek (Email: c.vandenbroek@elitechgroup.com) |
|---------------------|---------------------------------------------------------------|
| Date of Preparation | Thursday, September 9 <sup>th</sup> 2010 |
## Device name
Trade/proprietary Name: Common or Usual Name: Regulatory:
## ELITech Clinical Systems Selectra ProM Clinical analyzer, "ProM"
| Code | Name | Class | Regulation | Regulation Name | Panel |
|------|---------------------------------------------------------------------|-------|-----------------|---------------------------------------------------------------|--------------------------|
| JJE | analyzer, chemistry<br>(photometric, discrete),<br>for clinical use | I | 21 CFR 862.2160 | Discrete photometric chem-<br>istry analyzer for clinical use | 75 Clinical<br>Chemistry |
| JGS | Electrode, Ion-<br>Specific, Sodium | II | 21 CFR 862.1665 | Sodium test system | 75 Clinical<br>Chemistry |
| CEM | Electrode, Ion-<br>Specific, Potassium | II | 21 CFR 862.1600 | Potassium test system | 75 Clinical<br>Chemistry |
| CGZ | Electrode, Ion-<br>Specific, Chloride | II | 21 CFR 862.1170 | Chloride test system | 75 Clinical<br>Chemistry |
| CIT | NADH oxidation/NAD<br>reduction, AST/SGOT | II | 21 CFR 862.1100 | Aspartate amino transferase<br>(AST/SGOT) Test system | 75 Clinical<br>Chemistry |
| JIX | calibrator, multi-<br>analyte mixture | II | 21 CFR 862.1150 | Calibrator | 75 Clinical<br>Chemistry |
| JJY | multi-analyte con-<br>trols, all kinds (as-<br>sayed) | I | 21 CFR 862.1660 | Quality control material (as-<br>sayed and unassayed) | 75 Clinical<br>Chemistry |
## Establishment Information:
The establishment registration number for ELITech Vital Scientific BV is 8030478.
The establishment registration number for ELITech SEPPIM SAS is 3007662974.
The establishment registration number for ELITech Wescor USA is 1717966.
The owner operator number for ELITech North America (Wescor, Logan, UT, USA) is 1717966.
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## Predicate device:
| Predicate Instrument or reagent | 510(k) Number | Product code(s) |
|----------------------------------------------------------------------------------|---------------|-----------------------------|
| HORIBA ABX PENTRA 400 | K052007 | JJE JIX (also CEM CGZ JGS) |
| ROCHE cobas c111 | K071211 | JGS CEM CGZ CIT CFR JJE DCN |
| ABX PENTRA AST CP | K060318 | CIT JIX JJY |
| Roche Diagnostics Precinorn<br>Universal and Precipath Universal<br>Control Sera | K041227 | JJY |
| Roche Diagnostics Calibrator for<br>Automatic Systems (C.f.a.s.) | K033501 | JIX |
| Roche Standards for the Cobas<br>ISE Module | K897071 | JIX |
Substantial Equivalence: The ELITech Clinical Systems Selectra ProM is a new device developed by ELITech Vital Scientific BV. It has been demonstrated that the Selectra ProM is substantially equivalent to the predicate device. Horiba ABX PENTRA 400. The ISE Module is similarly demonstrated to be substantially equivalent to the ROCHE cobas c111 ISE. The ELITech Clinical Systems AST/GOT 4+1 SL, calibrated with ELITech Clinical Systems ELICAL 2 and controlled with ELITech Clinical Systems ELITROL I and ELITROL II, is substantially equivalent to HORIBA ABX AST CP, calibrated with Multical and controlled with N Control and P Control.
#### Device description The Selectra ProM is an automated, in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically: the analyzer also has an ISE module for measuring sodium, potassium and chloride electrometrically.
The Selectra ProM instrument is a random access analyzer designed to be operated on a bench top in the professional environment using a combination of a photometric analysis unit and an ion selective electrodes (ISE).
AST/GOT 4+1 SL is available as kit only. It consists of 2 reagents: Reagent 1 contains Tris buffer. L-Aspartate; Lactate dehydrogenase (LDH) (microorganisms), Malate dehydrogenase (MDH) (bacterial) and sodium azide. Reagent 2 contains α-Ketoglutarate, NADH and sodium azide.
The Sodium, Potassium and Chloride ISE Electrodes are comprised of the electrodes plus ISE Reference Solution, ISE Diluent, ISE Calibrators.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDAapproved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HV according to FDA-approved methods in compliance with the European Directive 98/79/EC, Annex II, List A.
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## Performance Standards
To date, no performance standards that affect this device have been finalized under Section 514 of the Act.
## Intended Use
See Indications for Use following
### Indications for Use:
Selectra ProM analyzer:
The ELITech Clinical system Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophotometric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidimetric assays. The second module is an electrometer used for measurement of electrolytes.
For in vitro diagnostic use only.
#### Reagents:
ELITech Clinical Systems AST/GOT 4+1 SL is a reagent for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate Amino Transferase (AST) in human serum and plasma on ELITech Clinical Systems Selectra ProM analyzer. Aspartate Amino Transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the ELITech Clinical Systems Selectra ProM analyzers.
ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in accuracy and precision of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.
ELITech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), and chloride (CI-) on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.
### ISE:
#### ISE Sodium Electrode
The sodium electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of sodium in serum and plasma. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine accompanied by extreme thirst), adrenal hypertension. Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate anticluretic hormone secretion or other diseases involving electrolyte imbalance.
### ISE Potassium Electrode
The potassium electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of potassium in serum and plasma. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
### ISE Chloride Electrode
: 上一:
The Chloride electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of chloride in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
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# Comparison to Predicate device
ANALYZER
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| Similarities and Differences | | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ELITech Clinical Systems Device<br>(Selectra ProM)<br>(AST/GOT 4+1 SL) | Predicate device<br>(ABX PENTRA 400 K052007)<br>(ABX PENTRA AST CP K060318) |
| Intended Use | The ELITech Clinical system Selectra<br>ProM is an automated clinical chemis-<br>try system intended for use in clinical<br>laboratories. It is intended to be used<br>for a variety of assay methods that<br>have been applied to spectropho-<br>tometric and electrochemical tech-<br>niques. The system has two core<br>modules: one consisting of a spectro-<br>photometric system for measurement<br>of analytes using spectrophotometric<br>techniques, such as end point, rate<br>and turbidimetric assays. The second<br>module is an electrometer used for<br>measurement of electrolytes.<br>For <i>in vitro</i> diagnostic use only. | An automated clinical chemistry sys-<br>tem intended for use in centralized<br>laboratories. It is intended to be used<br>for a variety of assay methods that<br>have been applied to spectropho-<br>tometric and electrochemical tech-<br>niques. |
| Operators | Professional setting | Professional setting |
## REAGENT
| Similarities and Differences | | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ELITech Clinical Systems Device<br>(Selectra ProM)<br>(AST/GOT 4+1 SL) | Predicate device<br>(ABX PENTRA 400 K052007)<br>(ABX PENTRA AST CP K060318) |
| Intended use/Indications for<br>Use | The Selectra ProM is an automated<br>clinical chemistry system intended for<br>use in clinical laboratories. It is in-<br>tended to be used for a variety of<br>assay methods that have been ap-<br>plied to spectrophotometric and elec-<br>trochemical techniques. | Same |
| Indication for Use for<br>reagent | Measurements of aspartate amino<br>transferase used in the diagnosis and<br>treatment of certain types of liver and<br>heart disease. | Same |
| Assay protocol | Modified IFCC method without pyridoxal -<br>phosphate | Optimized UV test according to IFCC<br>modified method without pyridoxal<br>phosphate. |
| Composition | Reagent R1:<br>TRIS pH 7.8, 100 mmol/L; L- Aspartate<br>330 mmol/L; MDH ≥ 1000 U/L; LDH ≥<br>2000 U/L; Sodium azide < 1g/L<br><br>Reagent R2:<br>α-Ketoglutarate 78 mmol/L; NADH 1.1<br>mmol/L; Sodium azide < 1g/L | Reagent R1:<br>TRIS pH 7.8 110 mmol/L; L-Aspartate<br>340 mmol/L; MDH ≥ 900 U/L; LDH ≥ 900<br>U/L; Sodium azide < 1g/L<br><br>Reagent R2:<br>2-oxoglutarate 85 mmol/L; NADH 1.09<br>mmol/L; Sodium azide < 1g/L |
| Appearance of reagents | Liquid form, ready to use | Liquid form, ready to use |
| Traceability/Standardization | IFCC formulation (Schumann, 2002),<br>manual measurement | IFCC Reference Measurement Procedure (37°C) for ASAT |
| Sample type | Serum<br>Plasma in lithium heparin | Serum<br>Plasma in lithium heparin |
| Reagent storage | Store at 2-8 °C and protected from<br>light. The reagents are stable until the<br>expiry date stated on the label | Reagents, in unopened cassette, are<br>stable up to expiry date on the label if<br>stored at 2-8°C, and contamination is<br>avoided. |
| Expected values | Serum, Plasma (37°C) :< 40 U/L | Women < 31 U/L<br>Men < 35 U/L 37°C |
| Measuring range | 10 to 250 U/L | 3.70 U/L to 600 U/L<br>Automatic post-dilution:1800 U/L |
| Limit of detection (LoD) | 0.8 U/L | 4 U/L |
| Limit of quantification (LoQ) | 5.0 U/L | |
| Precision | Within run | Within run |
| | Level 21.0 U/L CV=1.6%<br>Level 54.1 U/L CV=0.6%<br>Level 201.0 U/LCV=0.2%<br>Total<br>Level 21.0 U/L CV=2.1%<br>Level 54.1 U/L CV=1.5%<br>Level 201.0 U/LCV=1.4% | Level 42 U/L CV=2.7%<br>Level 123 U/L CV=1.4%<br>Level 22 U/L CV=2.3%<br>Level 38 U/L CV=2.0%<br>Level 145 U/L CV=1.1%<br>Total<br>Level 42 U/L CV=3.1%<br>Level 126 U/L CV=2.5%<br>Level 43 U/L CV=3.6%<br>Level 348 U/L CV=5.0% |
| Method comparison | y=1.028x - 0.16 U/L<br>r2= 0.996<br>range: 9.9 to 248.1 U/L | y=0.99x +1.01 U/L<br>r2= 0.9966<br>range: 3.70 to 671.80 U/L |
| Limitations | Turbidity: No significant interference<br>up to 614 mg/dL (7 mmol/L).<br>Pyruvate: No significant interference<br>up to 3 mg/dL.<br>Ascorbic acid: No significant inter-<br>ference up to 20 mg/dL (1.1 mmol/L).<br>Unconjugated bilirubin: No signifi-<br>cant interference up to 30 mg/dL (513<br>μmol/L).<br>Conjugated bilirubin: No significant<br>interference up to 29.5 mg/dL (504<br>μmol/L).<br><br>NOTE: Hemolyzed samples should not be<br>used since significant hemolysis may<br>increase AST concentration because of<br>high levels of AST in Erythrocytes. | Hemoglobin: No significant influence<br>is observed up to 95 mg/dL.<br>Triglycerides: No significant influ-<br>ence is observed up to 402.5 mg/dL<br>(as Intralipid® representative of li-<br>pemia).<br>Total bilirubin: No significant influ-<br>ence is observed up to 415 μmol/L.<br>Direct bilirubin: No significant influ-<br>ence is observed up to 362 μmol/L. |
| Calibration Frequency | 28 days | 8 days |
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refrigerated area : 28 days
On board stability
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refrigerated area: 55 days
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| CALIBRATOR:<br>Trade/proprietary Name:<br>Common or Usual Name:<br>Device Class<br>Classification name<br>Product code | ELITech Clinical Systems ELICAL 2<br>Calibrator, multi-analyte mixture, "ELICAL 2"<br>Class II<br>Calibrator (21 CFR 862.1150)<br>JIX- Calibrator, multi-analyte mixture |
|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate device | Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501) |
| Device description | ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human<br>serum containing constituents to ensure optimal calibration.<br>ELICAL 2 is prepared exclusively from the blood of donors tested individually and<br>found to be negative for HbsAg and to antibodies to HCV and HIV according to<br>FDA-approved methods or methods in compliance with the European Directive<br>98/79/EC, Annex II, List A. |
| Intended Use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro<br>diagnostic use in the calibration of quantitative ELITech Clinical Systems meth-<br>ods on the ELITech Clinical Systems Selectra ProM analyzers. |
:
## Comparison to Predicate device
| | ELITech Clinical Systems Device<br>(ELICAL 2) | Predicate device<br>(Roche Calibrator f.a.s. K033501) |
|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems ELICAL 2<br>is a multi-parametric calibrator for in<br>vitro diagnostic use in the calibra-<br>tion of quantitative ELITech Clinical<br>Systems methods on the ELITech<br>Clinical Systems Selectra ProM<br>analyzers. | For in vitro diagnostic use in the<br>calibration of quantitative Roche<br>methods on Roche clinical chemis-<br>try analysers as specified in the<br>value sheets. |
| Format | Lyophilized calibrator based on<br>human serum with constituents<br>added as required to obtain desired<br>components levels | Lyophilized calibrator based on<br>human serum with constituents<br>added as required to obtain desired<br>components levels |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding the<br>loss of lyophilate, and pipette in<br>exactly 3 mL of distilled/deionized<br>water. Carefully close the vial and<br>dissolve the contents completely by | Carefully open one bottle, avoiding<br>the loss of lyophilate, and pipette in<br>exactly 3 mL of distilled/deionized<br>water. Carefully close the bottle and<br>dissolve the contents completely by |
| | occasional gentle swirling within 30<br>minutes avoiding the formation of<br>foam. | occasional gentle swirling within 30<br>minutes. Avoid the formation of<br>foam. |
| Traceability | Traceability information is given in<br>the value sheet included in the box. | Traceability of the target value is<br>given in the respective instruction<br>for use of the system reagents. |
| Stability | Lyophilized:<br>To store at 2-8°C and protected<br>from light until the expiry date | Lyophilized:<br>Stable at 2-8°C up to expiration<br>date. |
| | After reconstitution, the stabilities<br>are:<br>- 8 hours between 15-25 °C.<br>- 2 days between 2-8 °C.<br>- 4 weeks between -25 and -15 °C<br>(when frozen once) | After reconstitution, the stabilities*<br>are :<br>- 8 hours at 15-25 °C.<br>- 2 days at 2-8 °C.<br>- 4 weeks at (-25)-(-15) °C (when<br>frozen once) |
| | | *Exception 'for bilirubin total & direct<br>as noted in package insert |
| CONTROLS:<br>Trade/proprietary Name:<br>Common or Usual Name:<br>Device Class<br>Classification name<br>Product code | ELITech Clinical Systems ELITROL I and ELITROL II<br>Multi-analyte controls - all kinds, "ELITROL I"- "ELITROL II"<br>Class I<br>Quality control material (assayed and unassayed). (21 CFR 862.1660)<br>JJX- Multi-analyte controls - all kinds | |
| Predicate device | Roche Diagnostics Precinorm U (K041227)<br>Roche Diagnostics Precipath U (K041227) | |
| Device description | ELITech Clinical Systems ELITROL I and ELITROL II are two level quality contr<br>products consisting of lyophilized human serum containing constituents at desired<br>levels.<br>Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested<br>individually and found to be negative for HbsAg and to antibodies to HCV and HIV<br>according to FDA-approved methods or methods in compliance with the Europea<br>Directive 98/79/EC, Annex II, List A. | |
| Intended Use | ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro<br>diagnostic use in accuracy control of quantitative ELITech Clinical Systems meth-<br>ods on the ELITech Clinical Systems ProM. | |
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## Comparison to Predicate device
| | ELITech Clinical Systems Device<br>ELITROL I / ELITROL II | Predicate Device<br>Roche Precinorm U / Precipath U<br>K041227 |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems ELITROL I &<br>ELITROL II are multiparametric control<br>sera for <i>in vitro</i> diagnostic use in accu-<br>racy and precision of quantitative<br>ELITech Clinical Systems methods on<br>ELITech Clinical Systems Selectra ProM<br>analyzer equipped with ISE module. | For <i>in vitro</i> diagnostic use in quality<br>control by monitoring accuracy and<br>precision for the quantitative methods<br>as specified in the value sheet |
| Format | Lyophilized human sera with constituents<br>added as required to obtain desired<br>components levels | Lyophilized human sera with constitu-<br>ents added as required to obtain de-<br>sired components levels |
| Levels | Two levels | Two levels |
| Handling | Carefully open the vial, avoiding the loss<br>of lyophilate, and pipette in exactly 5 mL<br>of distilled/deionized water. Carefully<br>close the vial and dissolve the contents<br>completely by occasional gentle swirling<br>within 30 minutes avoiding the formation<br>of foam. | Carefully open the bottle, avoiding the<br>loss of lyophilate, and pipette in exactly<br>5 mL of distilled/deionized water. Care-<br>fully close the bottle and dissolve the<br>contents completely by occasional<br>gentle swirling within 30 minutes.<br>Avoid the formation of foam. |
| Stability | Lyophilized:<br>To store at 2-8°C and protected from<br>light until the expiry date<br>After reconstitution, the stabilities are :<br>- 12 hours between 15-25 °C.<br>- 5 days between 2-8 °C.<br>- 4 weeks between -25 and -15 °C (when<br>frozen once) | Lyophilized:<br>Stable at 2-8°C up to expiration date.<br>After reconstitution, the stabilities* are :<br>- 12 hours at 15-25 °C.<br>- 5 days at 2-8 °C.<br>- 4 weeks at (-25)-(-15) °C (when fro-<br>zen once)<br>*Exception for bilirubin total & direct as<br>noted in package insert |
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| Similarities and Differences | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISE MODULE | ELITech Clinical Systems Device<br>(Selectra ProM ISE Module) | Predicate device<br>(ROCHE cobas C111 K0712) |
| Intended use/Indications for<br>Use | The Selectra ProM ISE module is an<br>electrometer used for measurement<br>of electrolytes. | Same |
| Intended use | used for the quantitative in vitro diag-<br>nostic determination of sodium (Na+),<br>potassium (K+), and chloride (Cl-) in<br>human serum and plasma | used for the quantitative in vitro diag-<br>nostic determination of sodium (Na+),<br>potassium (K+), and chloride (Cl-) in<br>diluted serum, plasma and urine |
| Indication for Use | Sodium measurements are used in<br>the diagnosis and treatment of elec-<br>trolyte and metabolic disorders.<br>Potassium measurements are used to<br>monitor electrolyte balance in the<br>diagnosis and treatment of diseases<br>conditions characterized by low or<br>high blood potassium levels.<br>Chloride measurements are used in<br>the diagnosis and treatment of elec-<br>trolyte and metabolic disorders. | Sodium measurements are used in<br>the diagnosis and treatment of aldos-<br>teronism (excessive secretion of the<br>hormone aldosterone), diabetes in-<br>sipidus (chronic excretion of large<br>amounts of dilute urine, accom-<br>by extreme thirst), adrenal hyp-<br>sion, Addison's disease (caused by<br>destruction of adrenal glands), dehy-<br>dration, inappropriate antidiuretic<br>hormone secretion, or other dis-<br>involving electrolyte imbalance<br>Potassium measurements are used to<br>monitor electrolyte balance in<br>diagnosis and treatment of dis-<br>conditions characterized by low or<br>high blood potassium levels.<br>Chloride measurements are used in<br>the diagnosis and treatment of elec-<br>trolyte and metabolic disorders<br>as cystic fibrosis and diabetic acido-<br>sis. |
| Test principle | | |
| Assay protocol | Indirect potentiometry measurement<br>with Ion-Selective Electrode | Indirect potentiometry measurement<br>with Ion Selective Electrode |
| Sample type | Serum and hemolysis-free plasma | Serum, plasma |
| General information | | |
| Expected values | Sodium:<br>Serum/plasma : 136-145 mmol/L | Sodium (adults):<br>Serum/plasma: 136-145 mmol/L |
| | Potassium:<br>Serum: 3.5 -5.1 mmol/L<br>Plasma: 3.4 - 4.5 mmol/L | Potassium (adults):<br>Serum: 3.5 -5.1 mmol/L<br>Plasma: 3.4 - 4.5 mmol/L |
| | Chloride: | Chloride (adults): |
| Performance characteristics | | |
| Method comparison | Sodium on serum<br>$y=1.042 x - 6.9$ mEq/L<br>$r= 0.996$<br>range: 83 to 196.2 mEq/L<br><br>Potassium on serum<br>$y=1.008 x - 0.08$ mEq/L<br>$r= 0.997$<br>range: 2.06 to 11.75 mEq/L<br><br>Chloride on serum<br>$y=0.950 x + 3.5$ mEq/L<br>$r= 0.992$<br>range: 70.2 to 166.8 mEq/L | Sodium on serum<br>$y=0.986 x - 0.364$ mmol/L<br>$r= 0.983$<br>range: 130 to 146 mmol/L<br><br>Potassium on serum<br>$y=0.984 x - 0.003$ mmol/L<br>$r= 1.000$<br>range: 3.3 to 11.83 mmol/L<br><br>Chloride on serum<br>$y=1.014 x - 3.236$ mmol/L<br>$r= 0.982$<br>range: 91 to 106 mmol/L |
| Limitations | Sodium:<br>Unconjugated bilirubin: No signifi-<br>cant interference up to 36 mg/dL (616<br>μmol/L).<br>Conjugated bilirubin: No significant<br>interference up to 25 mg/dL (427<br>μmol/L).<br>Turbidity: No significant interference<br>up to 614 mg/dL (7 mmol/L).<br>Acetylsalicylate: No significant inter-<br>ference up to 50 mg/dL (2.7 mmol/L).<br>Ascorbic acid: No significant inter-<br>ference up to 20 mg/dL (1.1 mmol/L).<br><br>Hyperlipemia or hyperproteinemia<br>lead to a negative bias in the meas-<br>urement of electrolyte because of<br>dilution effect. | Sodium : Serum/plasma<br>Hemolysis: Avoid hemolyzed speci-<br>mens. No significant interference up<br>to 1000 mg/dL of hemoglobin<br>Icterus: No significant interference up<br>to 60 mg/dL bilirubin<br>Lipemia: No significant interference<br>up to 2000 mg/dL of triglycerides<br>Dysproteinemia: No significant inter-<br>ference up to 3000 mg/dL<br>Drugs: A panel of drugs was tested<br>and caused no significant interfer-<br>ences when added to aliquots of<br>pooled normal human serum/plasma<br>up to the indicated concentration. |
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