(191 days)
Not Found
No
The summary describes a standard automated clinical chemistry analyzer using spectrophotometric and electrochemical techniques. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an automated clinical chemistry system intended for in vitro diagnostic use, which means it analyzes samples for diagnostic purposes rather than providing therapy.
Yes
The device is an "automated clinical chemistry system" and is described as "intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques" which includes the "measurement of analytes" and "measurement of electrolytes". The intended use statements for the AST/GOT reagent and the ISE electrodes directly link the measurements to the "diagnosis and treatment" of specific diseases (e.g., liver and heart disease, electrolyte imbalance, cystic fibrosis, diabetic acidosis). The text explicitly states "For in vitro diagnostic use only."
No
The device description clearly outlines a physical automated clinical chemistry system with hardware components (spectrophotometric system, electrometer, ISE module, electrodes) and associated reagents and calibrators. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For in vitro diagnostic use only."
- The ELITech Clinical system Selectra ProM is an "automated clinical chemistry system intended for use in clinical laboratories."
- The reagents, calibrators, and controls are all described as being for "in vitro diagnostic use".
- The ISE electrodes are intended for the "quantitative determination" of specific analytes in human serum and plasma, which are in vitro samples.
The "Device Description" also reinforces this by stating:
- The Selectra ProM is an "automated, in-vitro diagnostic analyzer".
These statements clearly indicate that the device and its associated components are intended for use in examining specimens derived from the human body in vitro for the purpose of providing information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / 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 the 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 (Cl-) 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
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.
Product codes (comma separated list FDA assigned to the subject device)
JJE, JGS, CEM, CGZ, CIT, JIX, JJY
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.
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
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Intended User / Care Setting
ELITech Clinical system Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories.
Professional setting
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)
Method comparison:
AST/GOT 4+1 SL: y=1.028x - 0.16 U/L, r2= 0.996, range: 9.9 to 248.1 U/L
Sodium on serum: y=1.042 x - 6.9 mEq/L, r= 0.996, range: 83 to 196.2 mEq/L
Potassium on serum: y=1.008 x - 0.08 mEq/L, r= 0.997, range: 2.06 to 11.75 mEq/L
Chloride on serum: y=0.950 x + 3.5 mEq/L, r= 0.992, range: 70.2 to 166.8 mEq/L
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LoD for AST/GOT 4+1 SL: 0.8 U/L
LoQ for AST/GOT 4+1 SL: 5.0 U/L
Precision for AST/GOT 4+1 SL:
Within run:
Level 21.0 U/L CV=1.6%
Level 54.1 U/L CV=0.6%
Level 201.0 U/L CV=0.2%
Total:
Level 21.0 U/L CV=2.1%
Level 54.1 U/L CV=1.5%
Level 201.0 U/L CV=1.4%
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.
K052007, K071211, K060318, K041227, K033501, K897071
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.
Not Found
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
§ 862.1665 Sodium test system.
(a)
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.(b)
Classification. Class II.
0
SECTION 5 - 510(k) Summary
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MAR 2 4 2011
る。
『『『』『『』『『』『『』『『』『』『『』『『』『『』『』『『』『『』『』『『』『『』『『』『『』『』『『』『『』『』『『』『『』『』『『』『『』『』『『』『『』『『』『『』『『』『『』『『』『』『『』『『』『『』『『』『『』『『』『』『『』『『』『『』『『』『『』『『』『『』『『』『『』『『』『『』『『』『『』『『』『『』『『』『『』
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 th 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 | ||||
| (photometric, discrete), | |||||
| for clinical use | I | 21 CFR 862.2160 | Discrete photometric chem- | ||
| istry analyzer for clinical use | 75 Clinical | ||||
| Chemistry | |||||
| JGS | Electrode, Ion- | ||||
| Specific, Sodium | II | 21 CFR 862.1665 | Sodium test system | 75 Clinical | |
| Chemistry | |||||
| CEM | Electrode, Ion- | ||||
| Specific, Potassium | II | 21 CFR 862.1600 | Potassium test system | 75 Clinical | |
| Chemistry | |||||
| CGZ | Electrode, Ion- | ||||
| Specific, Chloride | II | 21 CFR 862.1170 | Chloride test system | 75 Clinical | |
| Chemistry | |||||
| CIT | NADH oxidation/NAD | ||||
| reduction, AST/SGOT | II | 21 CFR 862.1100 | Aspartate amino transferase | ||
| (AST/SGOT) Test system | 75 Clinical | ||||
| Chemistry | |||||
| JIX | calibrator, multi- | ||||
| analyte mixture | II | 21 CFR 862.1150 | Calibrator | 75 Clinical | |
| Chemistry | |||||
| JJY | multi-analyte con- | ||||
| trols, all kinds (as- | |||||
| sayed) | I | 21 CFR 862.1660 | Quality control material (as- | ||
| sayed and unassayed) | 75 Clinical | ||||
| 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.
1
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 | ||
| Universal and Precipath Universal | ||
| Control Sera | K041227 | JJY |
| Roche Diagnostics Calibrator for | ||
| Automatic Systems (C.f.a.s.) | K033501 | JIX |
| Roche Standards for the Cobas | ||
| 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.
2
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.
3
Comparison to Predicate device
ANALYZER
i -----
| Similarities and Differences | ||
|---|---|---|
| ELITech Clinical Systems Device | ||
| (Selectra ProM) | ||
| (AST/GOT 4+1 SL) | Predicate device | |
| (ABX PENTRA 400 K052007) | ||
| (ABX PENTRA AST CP K060318) | ||
| Intended Use | The ELITech Clinical system Selectra | |
| ProM is an automated clinical chemis- | ||
| try system intended for use in clinical | ||
| laboratories. It is intended to be used | ||
| for a variety of assay methods that | ||
| have been applied to spectropho- | ||
| tometric and electrochemical tech- | ||
| niques. The system has two core | ||
| modules: one consisting of a spectro- | ||
| photometric 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. | An automated clinical chemistry sys- | |
| tem intended for use in centralized | ||
| laboratories. It is intended to be used | ||
| for a variety of assay methods that | ||
| have been applied to spectropho- | ||
| tometric and electrochemical tech- | ||
| niques. | ||
| Operators | Professional setting | Professional setting |
REAGENT
| Similarities and Differences | ||
|---|---|---|
| ELITech Clinical Systems Device | ||
| (Selectra ProM) | ||
| (AST/GOT 4+1 SL) | Predicate device | |
| (ABX PENTRA 400 K052007) | ||
| (ABX PENTRA AST CP K060318) | ||
| Intended use/Indications for | ||
| Use | The Selectra ProM is an automated | |
| clinical chemistry system intended for | ||
| use in clinical laboratories. It is in- | ||
| tended to be used for a variety of | ||
| assay methods that have been ap- | ||
| plied to spectrophotometric and elec- | ||
| trochemical techniques. | Same | |
| Indication for Use for | ||
| reagent | Measurements of aspartate amino | |
| transferase used in the diagnosis and | ||
| treatment of certain types of liver and | ||
| heart disease. | Same | |
| Assay protocol | Modified IFCC method without pyridoxal - | |
| phosphate | Optimized UV test according to IFCC | |
| modified method without pyridoxal | ||
| phosphate. | ||
| Composition | Reagent R1: | |
| TRIS pH 7.8, 100 mmol/L; L- Aspartate | ||
| 330 mmol/L; MDH ≥ 1000 U/L; LDH ≥ | ||
| 2000 U/L; Sodium azide in vitro diagnostic use in accu- | ||
| racy and precision of quantitative | ||
| ELITech Clinical Systems methods on | ||
| ELITech Clinical Systems Selectra ProM | ||
| analyzer equipped with ISE module. | For in vitro diagnostic use in quality | |
| control by monitoring accuracy and | ||
| precision for the quantitative methods | ||
| as specified in the value sheet | ||
| Format | Lyophilized human sera with constituents | |
| added as required to obtain desired | ||
| components levels | Lyophilized human sera with constitu- | |
| ents added as required to obtain de- | ||
| sired components levels | ||
| Levels | Two levels | Two levels |
| Handling | Carefully open the vial, avoiding the loss | |
| of lyophilate, and pipette in exactly 5 mL | ||
| of distilled/deionized water. Carefully | ||
| close the vial and dissolve the contents | ||
| completely by occasional gentle swirling | ||
| within 30 minutes avoiding the formation | ||
| of foam. | Carefully open the bottle, avoiding the | |
| loss of lyophilate, and pipette in exactly | ||
| 5 mL of distilled/deionized water. Care- | ||
| fully close the bottle and dissolve the | ||
| contents completely by occasional | ||
| gentle swirling within 30 minutes. | ||
| Avoid the formation of foam. | ||
| Stability | Lyophilized: | |
| To store at 2-8°C and protected from | ||
| light until the expiry date | ||
| After reconstitution, the stabilities are : |
- 12 hours between 15-25 °C.
- 5 days between 2-8 °C.
- 4 weeks between -25 and -15 °C (when
frozen once) | Lyophilized:
Stable at 2-8°C up to expiration date.
After reconstitution, the stabilities* are : - 12 hours at 15-25 °C.
- 5 days at 2-8 °C.
- 4 weeks at (-25)-(-15) °C (when fro-
zen once)
*Exception for bilirubin total & direct as
noted in package insert |
י り: ・ : ..
·
8
| Similarities and Differences | ||
|---|---|---|
| ISE MODULE | ELITech Clinical Systems Device | |
| (Selectra ProM ISE Module) | Predicate device | |
| (ROCHE cobas C111 K0712) | ||
| Intended use/Indications for | ||
| Use | The Selectra ProM ISE module is an | |
| electrometer used for measurement | ||
| of electrolytes. | Same | |
| Intended use | used for the quantitative in vitro diag- | |
| nostic determination of sodium (Na+), | ||
| potassium (K+), and chloride (Cl-) in | ||
| human serum and plasma | used for the quantitative in vitro diag- | |
| nostic determination of sodium (Na+), | ||
| potassium (K+), and chloride (Cl-) in | ||
| diluted serum, plasma and urine | ||
| Indication for Use | Sodium measurements are used in | |
| the diagnosis and treatment of elec- | ||
| trolyte and metabolic disorders. | ||
| Potassium measurements are used to | ||
| monitor electrolyte balance in the | ||
| diagnosis and treatment of diseases | ||
| conditions characterized by low or | ||
| high blood potassium levels. | ||
| Chloride measurements are used in | ||
| the diagnosis and treatment of elec- | ||
| trolyte and metabolic disorders. | Sodium measurements are used in | |
| the diagnosis and treatment of aldos- | ||
| teronism (excessive secretion of the | ||
| hormone aldosterone), diabetes in- | ||
| sipidus (chronic excretion of large | ||
| amounts of dilute urine, accom- | ||
| by extreme thirst), adrenal hyp- | ||
| sion, Addison's disease (caused by | ||
| destruction of adrenal glands), dehy- | ||
| dration, inappropriate antidiuretic | ||
| hormone secretion, or other dis- | ||
| involving electrolyte imbalance | ||
| Potassium measurements are used to | ||
| monitor electrolyte balance in | ||
| diagnosis and treatment of dis- | ||
| conditions characterized by low or | ||
| high blood potassium levels. | ||
| Chloride measurements are used in | ||
| the diagnosis and treatment of elec- | ||
| trolyte and metabolic disorders | ||
| as cystic fibrosis and diabetic acido- | ||
| sis. | ||
| Test principle | ||
| Assay protocol | Indirect potentiometry measurement | |
| with Ion-Selective Electrode | Indirect potentiometry measurement | |
| with Ion Selective Electrode | ||
| Sample type | Serum and hemolysis-free plasma | Serum, plasma |
| General information | ||
| Expected values | Sodium: | |
| Serum/plasma : 136-145 mmol/L | Sodium (adults): | |
| Serum/plasma: 136-145 mmol/L | ||
| Potassium: | ||
| Serum: 3.5 -5.1 mmol/L | ||
| Plasma: 3.4 - 4.5 mmol/L | Potassium (adults): | |
| Serum: 3.5 -5.1 mmol/L | ||
| Plasma: 3.4 - 4.5 mmol/L | ||
| Chloride: | Chloride (adults): | |
| Performance characteristics | ||
| Method comparison | Sodium on serum | |
| $y=1.042 x - 6.9$ mEq/L | ||
| $r= 0.996$ | ||
| range: 83 to 196.2 mEq/L |
Potassium on serum
$y=1.008 x - 0.08$ mEq/L
$r= 0.997$
range: 2.06 to 11.75 mEq/L
Chloride on serum
$y=0.950 x + 3.5$ mEq/L
$r= 0.992$
range: 70.2 to 166.8 mEq/L | Sodium on serum
$y=0.986 x - 0.364$ mmol/L
$r= 0.983$
range: 130 to 146 mmol/L
Potassium on serum
$y=0.984 x - 0.003$ mmol/L
$r= 1.000$
range: 3.3 to 11.83 mmol/L
Chloride on serum
$y=1.014 x - 3.236$ mmol/L
$r= 0.982$
range: 91 to 106 mmol/L |
| Limitations | Sodium:
Unconjugated bilirubin: No signifi-
cant interference up to 36 mg/dL (616
μmol/L).
Conjugated bilirubin: No significant
interference up to 25 mg/dL (427
μmol/L).
Turbidity: No significant interference
up to 614 mg/dL (7 mmol/L).
Acetylsalicylate: No significant inter-
ference up to 50 mg/dL (2.7 mmol/L).
Ascorbic acid: No significant inter-
ference up to 20 mg/dL (1.1 mmol/L).
Hyperlipemia or hyperproteinemia
lead to a negative bias in the meas-
urement of electrolyte because of
dilution effect. | Sodium : Serum/plasma
Hemolysis: Avoid hemolyzed speci-
mens. No significant interference up
to 1000 mg/dL of hemoglobin
Icterus: No significant interference up
to 60 mg/dL bilirubin
Lipemia: No significant interference
up to 2000 mg/dL of triglycerides
Dysproteinemia: No significant inter-
ference up to 3000 mg/dL
Drugs: A panel of drugs was tested
and caused no significant interfer-
ences when added to aliquots of
pooled normal human serum/plasma
up to the indicated concentration. |
| | Potassium:
Unconjugated bilirubin: No signifi-
cant interference up to 36 mg/dL (616
μmol/L).
Conjugated bilirubin: No significant
interference up to 25 mg/dL (427
μmol/L).
Turbidity: No significant interference
up to 614 mg/dL (7 mmol/L).
Acetylsalicylate: No significant inter-
ference up to 50 mg/dL (2.7 mmol/L).
Ascorbic acid: No significant inter-
ference up to 20 mg/dL (1.1 mmol/L).
Hemolysis may increase the potas- | Potassium : Serum/plasma
Hemolysis: Avoid hemolyzed speci-
mens. No significant interference up
to 100 mg/dL of hemoglobin. Potas-
sium concentration in erythrocytes is
25 times higher than in normal plas-
ma. The level of interference may be
variable depending on the exact con-
tent of erythrocytes
Icterus: No significant interference up
to 60 mg/dL bilirubin.
Lipemia: No significant interference
up to 2000 mg/dL of triglycerides.
Dysproteinemia: No significant inter-
ference up to 3000 mg/dL. |
| | because of high potassium concentra-
tion in erythrocytes.
Hyperlipemia or hyperproteinemia
lead to a negative bias in the meas-
urement of electrolyte because of
dilution effect. | Drugs: A panel of drugs was tested
and caused no significant interfer-
ences when added to aliquots of
pooled normal human serum/plasma
up to the indicated concentration. |
| | Chloride:
Unconjugated bilirubin: No signifi-
cant interference up to 36 mg/dL (616
µmol/L).
Conjugated bilirubin: No significant
interference up to 25 mg/dL (427
μmol/L).
Turbidity: No significant interference
up to 614 mg/dL (7 mmol/L).
Acetylsalicylate: No significant inter-
ference up to 50 mg/dL (2.7 mmol/L).
Ascorbic acid: No significant inter-
ference up to 20 mg/dL (1.1 mmol/L).
Hyperlipemia or hyperproteinemia
lead to a negative bias in the meas-
urement of electrolyte because of
dilution effect. | Chloride: Serum/plasma
Hemolysis: Avoid hemolyzed speci-
mens. No significant interference up
to 1000 mg/dL of hemoglobin.
Icterus: No significant interference up
to 60 mg/dL bilirubin.
Lipemia: No significant interference
up to 2000 mg/dL of triglycerides
Dysproteinemia: No significant inter-
ference up to 3000 mg/dL.
Drugs: A panel of drugs was tested
and caused no significant interfer-
ences when added to aliquots of
pooled normal human serum/plasma
up to the indicated concentration. In
addition to the tested drug panel, sali-
cylic acid measured. The highest con-
centration (5 mmol/L) causes artifi-
cially elevated chloride concentrations |
| Traceability | According the following reference
material :
Na+ NIST SRM 919b
K+ NIST SRM 918b
Cl- NIST SRM 918b/919b | This method has been standardized
against primary calibrators prepared
gravimetrically from purified salts. |
| Calibration Frequency | It is recommended to recalibrate after
setting-up of a new vial of ISE Refer-
ence Solution or of ISE Diluent then
every 4 hours when quality control
results fall outside the established
range, after replacing electrode, and
after ISE cleaning and maintenance | 24 hours (main calibration) after ISE
cleaning and maintenance, after
changing the reagent bottles after
replacing electrodes |
| ISE
CALIBRATOR | ELITech Clinical Systems Device
(ISE Calibrator) | Predicate device
Roche Standards for the Cobas ISE
Module K897071 |
| ISE Calibrators | Composition:
Aqueous solutions containing sodium,
potassium and chloride with 2 differ-
ent levels of concentrations.
Concentrations are lot-specific. The
values are given in the vial labels. | ISE Calibration kit
Composition:
Aqueous preparations with different
levels of concentrations level 1 and
level 2
ISE Solution 1 :
Na+ 150 mmol/L
K+ 5 mmol/L |
| | Cl⁻: 115 mmol/L
ISE Solution 2:
Na⁺: 110 mmol/L
K⁺: 1.8 mmol/L
Cl⁻: 72 mmol/L | |
| Storage:
Store at 2-30 °C. These calibrators are stable until the expiry date stated on the label. Do not freeze. | Storage:
Store at 2-8 °C. These calibrators are stable until the expiry date stated on the label. | |
| Stability:
- Calibrators are stable until the expiry date stated on the label.
- After opening, calibrators is stable 30 days when stored at 2-30 °C
Note: Calibrators should be immediately and tightly capped to prevent contamination and evaporation. | Stability: - Calibrators are stable until the expiry date stated on the label.
- After opening, calibrators is stable 4 weeks when stored at 2-8 °C
Note: Close opened bottles immediately after use and store at 2-8 °C. | |
| | ISE Calibrator indirect /urine
Composition:
Sodium (Na⁺): 25 mmol/L
Potassium (K⁺): 0.83 mmol/L
Chloride (Cl⁻): 19.2 mmol/L
Storage:
Store at 15-25 °C. This solution is stable until the expiry date stated on the label. | |
・
9
and the state of the state of the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the sta
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,
:、
10
11
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate devices in its intended use locations.
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12
Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
ELITech Group Vital Scientific BV c/o Debra Hutson ELITech Group Epoch Biosciences 21720 23td Dr. SE. Suite 150 Bothell, Washington 98021
MAR 2 4 2011
Re: K102647
Trade Name: AST/GOT 4+1 SL Regulation Number: 21 CFR §862.1100 Regulation Name: Aspartate aminotransferase (AST/SGOT) Test System Regulatory Class: Class II Product Codes: CIT, JGS, CEM, CGZ, JIX, JJY and JJE Dated: March 4, 2011 Received: March 7, 2011
Dear Ms. Hutson:
:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class 111 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
13
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CF N Falls 601 (301) 796-5450. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollil the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
14
510(k) Number (if known): _ K |081047_________________________________________________________________________________________________________________________________________
Device Name: ELITech Clinical Systems Selectra ProM
Indications for 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K10264
page: 1 of 6
15
510(k) Number (if known): _ K 102647
Device Name:
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K1/02647
2 of 6
16
510(k) Number (if known): _ | 1021047 _
ELITech Clinical Systems ISE Na, K, CI Electrodes_ Device Name:
Indications for Use:
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 antidiuretic 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
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k/0264]
17
510(k) Number (if known): _ K |001047
ELITech Clinical Systems ELITROL 1 & ELITROLII_ Device Name:
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102647
4 of 6
.
18
510(k) Number (if known): _ | |02/047
ELITech Clinical Systems ISE Calibrators Device Name:
Indications for Use:
ELITech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), and chloride (Cl-) on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Dividing Officer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102647
5 of 6
19
510(k) Number (if known):
Device Name:
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
6 of 6
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K[0264]