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.

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 (Cl-) on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.

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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the ELITech Clinical Systems Selectra ProM, an automated in-vitro diagnostic analyzer, along with associated reagents and calibrators. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel performance. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of comparative performance to established predicate devices.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

The document presents performance characteristics for the ELITech Clinical Systems Selectra ProM analyzer, the AST/GOT 4+1 SL reagent, and the ISE module (Sodium, Potassium, Chloride electrodes) by comparing them to predicate devices. The "acceptance criteria" are implied to be that the new device's performance is comparable to or better than the predicate's, thus demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit "acceptance criteria" (e.g., target CV% or r-squared values that must be met) are not directly stated as pass/fail thresholds but rather implied by comparison to predicates, I will present the comparative data provided. The reported performance of the ELITech device is compared directly against its predicate.

Performance Metric	ELITech Clinical Systems Selectra ProM (and AST/GOT 4+1 SL reagent)	Predicate (HORIBA ABX PENTRA 400 & ABX PENTRA AST CP)	ELITech Clinical Systems Selectra ProM (ISE Module)	Predicate (ROCHE cobas c111 ISE Module)
AST Reagent			ISE Sodium
Measuring Range	10 to 250 U/L	3.70 U/L to 600 U/L (with auto post-dilution: 1800 U/L)	Method Comparison (y)	y = 1.042x - 6.9 mEq/L
Limit of Detection (LoD)	0.8 U/L	4 U/L	Method Comparison (r)	r = 0.996
Limit of Quantification (LoQ)	5.0 U/L	Not specified	Method Comparison (range)	83 to 196.2 mEq/L
Precision (Within run)	Level 21.0 U/L CV=1.6%	Level 42 U/L CV=2.7%	ISE Potassium
	Level 54.1 U/L CV=0.6%	Level 123 U/L CV=1.4%	Method Comparison (y)	y = 1.008x - 0.08 mEq/L
	Level 201.0 U/L CV=0.2%	Level 22 U/L CV=2.3%	Method Comparison (r)	r = 0.997
		Level 38 U/L CV=2.0%	Method Comparison (range)	2.06 to 11.75 mEq/L
	Level 145 U/L CV=1.1%		ISE Chloride
Precision (Total)	Level 21.0 U/L CV=2.1%	Level 42 U/L CV=3.1%	Method Comparison (y)	y = 0.950x + 3.5 mEq/L
	Level 54.1 U/L CV=1.5%	Level 126 U/L CV=2.5%	Method Comparison (r)	r = 0.992
	Level 201.0 U/L CV=1.4%	Level 43 U/L CV=3.6%	Method Comparison (range)	70.2 to 166.8 mEq/L
		Level 348 U/L CV=5.0%
Method Comparison (y)	y = 1.028x - 0.16 U/L	y = 0.99x + 1.01 U/L
Method Comparison (r²)	r² = 0.996	r² = 0.9966
Method Comparison (range)	9.9 to 248.1 U/L	3.70 to 671.80 U/L
Calibration Frequency	28 days	8 days	Recommended to recalibrate every 4 hours or after certain events (e.g., changing solution)	24 hours (main calibration) or after certain events

Interpretation: The reported performance indicators (e.g., CV for precision, r and r² for method comparison) are comparable to the predicate devices, supporting the claim of substantial equivalence. For instance, the AST reagent shows competitive precision and a strong correlation with the predicate method. Similarly, the ISE module demonstrates high correlation coefficients (r-values) when compared to its predicate.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the test sets (e.g., for method comparison or precision studies). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective. It only mentions testing on "human serum and plasma."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. For in-vitro diagnostic devices like clinical chemistry analyzers, "ground truth" is typically established by reference methods or established laboratory practices, not by expert consensus from medical professionals in a qualitative assessment sense. The document refers to "IFCC formulation" and "manual measurement" for AST traceability, and "primary calibrators prepared gravimetrically from purified salts" for ISE traceability, indicating reliance on established scientific and metrological standards rather than expert panel consensus for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where subjective expert review is involved (e.g., imaging diagnostics). For an in-vitro diagnostic device performing quantitative measurements, performance is typically evaluated against gold standard methods or established predicate devices using quantitative statistical comparisons.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of in-vitro diagnostic device. MRMC studies are primarily used for evaluating diagnostic imaging systems where human readers interpret images. This device performs automated chemical analysis, not human-interpreted diagnostic output. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the studies presented are effectively standalone performance evaluations for the ELITech Clinical Systems Selectra ProM analyzer and its reagents. The device is an automated system designed to perform measurements without direct human intervention in the analytical process. The method comparison and precision studies demonstrate the algorithm's (device's) performance in generating quantitative results. The human element is in operating the device and interpreting the results within a clinical context, but the performance data provided directly reflects the automated system's capabilities.

7. The Type of Ground Truth Used:

The ground truth for the performance evaluations (e.g., method comparison studies) relies on:

Reference Measurement Procedures/Established Methods: For AST, it mentions "IFCC formulation (Schumann, 2002), manual measurement" and comparison to a predicate that uses "IFCC modified method."
Primary Calibrators/Metrological Traceability: For the ISE module, it states that the method has been standardized "against primary calibrators prepared gravimetrically from purified salts" and traces to "NIST SRM 919b" and "NIST SRM 918b" for Sodium and Potassium, respectively, and "NIST SRM 918b/919b" for Chloride.
Predicate Device Measurements: In comparison studies, the results from the predicate devices (HORIBA ABX PENTRA 400 and ROCHE cobas c111 ISE) serve as the comparative standard.

8. The Sample Size for the Training Set:

This information is not applicable or not provided. Clinical chemistry analyzers and their reagents are typically developed and validated using a combination of laboratory-prepared samples, spiked samples, and patient samples. The term "training set" is more commonly associated with machine learning or artificial intelligence algorithms. While the instrument and reagent parameters are "trained" or optimized during development, specific sample sizes for such an internal "training set" are not disclosed in regulatory submissions of this type. The provided document details validation (test set) performance, not internal development/training data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable or not provided for the reasons stated above in point 8. The "ground truth" for optimizing instrument parameters and reagent formulations during development would implicitly come from rigorous internal testing against known standards, reference materials, and established laboratory methods to ensure accuracy and precision across the measuring range.

Summary

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SECTION 5 - 510(k) Summary

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
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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 ClinicalChemistry
JGS	Electrode, Ion-Specific, Sodium	II	21 CFR 862.1665	Sodium test system	75 ClinicalChemistry
CEM	Electrode, Ion-Specific, Potassium	II	21 CFR 862.1600	Potassium test system	75 ClinicalChemistry
CGZ	Electrode, Ion-Specific, Chloride	II	21 CFR 862.1170	Chloride test system	75 ClinicalChemistry
CIT	NADH oxidation/NADreduction, AST/SGOT	II	21 CFR 862.1100	Aspartate amino transferase(AST/SGOT) Test system	75 ClinicalChemistry
JIX	calibrator, multi-analyte mixture	II	21 CFR 862.1150	Calibrator	75 ClinicalChemistry
JJY	multi-analyte con-trols, all kinds (as-sayed)	I	21 CFR 862.1660	Quality control material (as-sayed and unassayed)	75 ClinicalChemistry

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 PrecinornUniversal and Precipath UniversalControl Sera	K041227	JJY
Roche Diagnostics Calibrator forAutomatic Systems (C.f.a.s.)	K033501	JIX
Roche Standards for the CobasISE 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).

The Sodium, Potassium and Chloride ISE Electrodes are comprised of the electrodes plus ISE Reference Solution, ISE Diluent, ISE Calibrators.

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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:

For in vitro diagnostic use only.

Reagents:

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(Selectra ProM)(AST/GOT 4+1 SL)	Predicate device(ABX PENTRA 400 K052007)(ABX PENTRA AST CP K060318)
Intended Use	The ELITech Clinical system SelectraProM is an automated clinical chemis-try system intended for use in clinicallaboratories. It is intended to be usedfor a variety of assay methods thathave been applied to spectropho-tometric and electrochemical tech-niques. The system has two coremodules: one consisting of a spectro-photometric system for measurementof analytes using spectrophotometrictechniques, such as end point, rateand turbidimetric assays. The secondmodule is an electrometer used formeasurement of electrolytes.For in vitro diagnostic use only.	An automated clinical chemistry sys-tem intended for use in centralizedlaboratories. It is intended to be usedfor a variety of assay methods thathave 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 forUse	The Selectra ProM is an automatedclinical chemistry system intended foruse in clinical laboratories. It is in-tended to be used for a variety ofassay methods that have been ap-plied to spectrophotometric and elec-trochemical techniques.	Same
Indication for Use forreagent	Measurements of aspartate aminotransferase used in the diagnosis andtreatment of certain types of liver andheart disease.	Same
Assay protocol	Modified IFCC method without pyridoxal -phosphate	Optimized UV test according to IFCCmodified method without pyridoxalphosphate.
Composition	Reagent R1:TRIS pH 7.8, 100 mmol/L; L- Aspartate330 mmol/L; MDH ≥ 1000 U/L; LDH ≥2000 U/L; Sodium azide < 1g/LReagent R2:α-Ketoglutarate 78 mmol/L; NADH 1.1mmol/L; Sodium azide < 1g/L	Reagent R1:TRIS pH 7.8 110 mmol/L; L-Aspartate340 mmol/L; MDH ≥ 900 U/L; LDH ≥ 900U/L; Sodium azide < 1g/LReagent R2:2-oxoglutarate 85 mmol/L; NADH 1.09mmol/L; Sodium azide < 1g/L
Appearance of reagents	Liquid form, ready to use	Liquid form, ready to use
Traceability/Standardization	IFCC formulation (Schumann, 2002),manual measurement	IFCC Reference Measurement Procedure (37°C) for ASAT
Sample type	SerumPlasma in lithium heparin	SerumPlasma in lithium heparin
Reagent storage	Store at 2-8 °C and protected fromlight. The reagents are stable until theexpiry date stated on the label	Reagents, in unopened cassette, arestable up to expiry date on the label ifstored at 2-8°C, and contamination isavoided.
Expected values	Serum, Plasma (37°C) :< 40 U/L	Women < 31 U/LMen < 35 U/L 37°C
Measuring range	10 to 250 U/L	3.70 U/L to 600 U/LAutomatic 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%Level 54.1 U/L CV=0.6%Level 201.0 U/LCV=0.2%TotalLevel 21.0 U/L CV=2.1%Level 54.1 U/L CV=1.5%Level 201.0 U/LCV=1.4%	Level 42 U/L CV=2.7%Level 123 U/L CV=1.4%Level 22 U/L CV=2.3%Level 38 U/L CV=2.0%Level 145 U/L CV=1.1%TotalLevel 42 U/L CV=3.1%Level 126 U/L CV=2.5%Level 43 U/L CV=3.6%Level 348 U/L CV=5.0%
Method comparison	y=1.028x - 0.16 U/Lr2= 0.996range: 9.9 to 248.1 U/L	y=0.99x +1.01 U/Lr2= 0.9966range: 3.70 to 671.80 U/L
Limitations	Turbidity: No significant interferenceup to 614 mg/dL (7 mmol/L).Pyruvate: No significant interferenceup to 3 mg/dL.Ascorbic acid: No significant inter-ference up to 20 mg/dL (1.1 mmol/L).Unconjugated bilirubin: No signifi-cant interference up to 30 mg/dL (513μmol/L).Conjugated bilirubin: No significantinterference up to 29.5 mg/dL (504μmol/L).NOTE: Hemolyzed samples should not beused since significant hemolysis mayincrease AST concentration because ofhigh levels of AST in Erythrocytes.	Hemoglobin: No significant influenceis observed up to 95 mg/dL.Triglycerides: No significant influ-ence is observed up to 402.5 mg/dL(as Intralipid® representative of li-pemia).Total bilirubin: No significant influ-ence is observed up to 415 μmol/L.Direct bilirubin: No significant influ-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

. ジン・・・・

refrigerated area: 55 days

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CALIBRATOR:Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code	ELITech Clinical Systems ELICAL 2Calibrator, multi-analyte mixture, "ELICAL 2"Class IICalibrator (21 CFR 862.1150)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 humanserum containing constituents to ensure optimal calibration.ELICAL 2 is prepared exclusively from the blood of donors tested individually andfound to be negative for HbsAg and to antibodies to HCV and HIV according toFDA-approved methods or methods in compliance with the European Directive98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitrodiagnostic use in the calibration of quantitative ELITech Clinical Systems meth-ods on the ELITech Clinical Systems Selectra ProM analyzers.

Comparison to Predicate device

	ELITech Clinical Systems Device(ELICAL 2)	Predicate device(Roche Calibrator f.a.s. K033501)
Intended use	ELITech Clinical Systems ELICAL 2is a multi-parametric calibrator for invitro diagnostic use in the calibra-tion of quantitative ELITech ClinicalSystems methods on the ELITechClinical Systems Selectra ProManalyzers.	For in vitro diagnostic use in thecalibration of quantitative Rochemethods on Roche clinical chemis-try analysers as specified in thevalue sheets.
Format	Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels	Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels
Level	Single level	Single level
Handling	Carefully open the vial, avoiding theloss of lyophilate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely by	Carefully open one bottle, avoidingthe loss of lyophilate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely by
	occasional gentle swirling within 30minutes avoiding the formation offoam.	occasional gentle swirling within 30minutes. Avoid the formation offoam.
Traceability	Traceability information is given inthe value sheet included in the box.	Traceability of the target value isgiven in the respective instructionfor use of the system reagents.
Stability	Lyophilized:To store at 2-8°C and protectedfrom light until the expiry date	Lyophilized:Stable at 2-8°C up to expirationdate.
	After reconstitution, the stabilitiesare:- 8 hours between 15-25 °C.- 2 days between 2-8 °C.- 4 weeks between -25 and -15 °C(when frozen once)	After reconstitution, the stabilities*are :- 8 hours at 15-25 °C.- 2 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once)
		*Exception 'for bilirubin total & directas noted in package insert
CONTROLS:Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code	ELITech Clinical Systems ELITROL I and ELITROL IIMulti-analyte controls - all kinds, "ELITROL I"- "ELITROL II"Class IQuality control material (assayed and unassayed). (21 CFR 862.1660)JJX- Multi-analyte controls - all kinds
Predicate device	Roche Diagnostics Precinorm U (K041227)Roche Diagnostics Precipath U (K041227)
Device description	ELITech Clinical Systems ELITROL I and ELITROL II are two level quality contrproducts consisting of lyophilized human serum containing constituents at desiredlevels.Elitrol I and Elitrol II are prepared exclusively from the blood of donors testedindividually and found to be negative for HbsAg and to antibodies to HCV and HIVaccording to FDA-approved methods or methods in compliance with the EuropeaDirective 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitrodiagnostic use in accuracy control of quantitative ELITech Clinical Systems meth-ods on the ELITech Clinical Systems ProM.

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Comparison to Predicate device

	ELITech Clinical Systems DeviceELITROL I / ELITROL II	Predicate DeviceRoche Precinorm U / Precipath UK041227
Intended use	ELITech Clinical Systems ELITROL I &ELITROL II are multiparametric controlsera for in vitro diagnostic use in accu-racy and precision of quantitativeELITech Clinical Systems methods onELITech Clinical Systems Selectra ProManalyzer equipped with ISE module.	For in vitro diagnostic use in qualitycontrol by monitoring accuracy andprecision for the quantitative methodsas specified in the value sheet
Format	Lyophilized human sera with constituentsadded as required to obtain desiredcomponents 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 lossof lyophilate, and pipette in exactly 5 mLof distilled/deionized water. Carefullyclose the vial and dissolve the contentscompletely by occasional gentle swirlingwithin 30 minutes avoiding the formationof foam.	Carefully open the bottle, avoiding theloss of lyophilate, and pipette in exactly5 mL of distilled/deionized water. Care-fully close the bottle and dissolve thecontents completely by occasionalgentle swirling within 30 minutes.Avoid the formation of foam.
Stability	Lyophilized:To store at 2-8°C and protected fromlight until the expiry dateAfter reconstitution, the stabilities are :- 12 hours between 15-25 °C.- 5 days between 2-8 °C.- 4 weeks between -25 and -15 °C (whenfrozen 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 asnoted in package insert

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Similarities and Differences
ISE MODULE	ELITech Clinical Systems Device(Selectra ProM ISE Module)	Predicate device(ROCHE cobas C111 K0712)
Intended use/Indications forUse	The Selectra ProM ISE module is anelectrometer used for measurementof electrolytes.	Same
Intended use	used for the quantitative in vitro diag-nostic determination of sodium (Na+),potassium (K+), and chloride (Cl-) inhuman serum and plasma	used for the quantitative in vitro diag-nostic determination of sodium (Na+),potassium (K+), and chloride (Cl-) indiluted serum, plasma and urine
Indication for Use	Sodium measurements are used inthe diagnosis and treatment of elec-trolyte and metabolic disorders.Potassium measurements are used tomonitor electrolyte balance in thediagnosis and treatment of diseasesconditions characterized by low orhigh blood potassium levels.Chloride measurements are used inthe diagnosis and treatment of elec-trolyte and metabolic disorders.	Sodium measurements are used inthe diagnosis and treatment of aldos-teronism (excessive secretion of thehormone aldosterone), diabetes in-sipidus (chronic excretion of largeamounts of dilute urine, accom-by extreme thirst), adrenal hyp-sion, Addison's disease (caused bydestruction of adrenal glands), dehy-dration, inappropriate antidiuretichormone secretion, or other dis-involving electrolyte imbalancePotassium measurements are used tomonitor electrolyte balance indiagnosis and treatment of dis-conditions characterized by low orhigh blood potassium levels.Chloride measurements are used inthe diagnosis and treatment of elec-trolyte and metabolic disordersas cystic fibrosis and diabetic acido-sis.
Test principle
Assay protocol	Indirect potentiometry measurementwith Ion-Selective Electrode	Indirect potentiometry measurementwith 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/LPlasma: 3.4 - 4.5 mmol/L	Potassium (adults):Serum: 3.5 -5.1 mmol/LPlasma: 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/LPotassium on serum$y=1.008 x - 0.08$ mEq/L$r= 0.997$range: 2.06 to 11.75 mEq/LChloride 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/LPotassium on serum$y=0.984 x - 0.003$ mmol/L$r= 1.000$range: 3.3 to 11.83 mmol/LChloride 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 (616μmol/L).Conjugated bilirubin: No significantinterference up to 25 mg/dL (427μmol/L).Turbidity: No significant interferenceup 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 hyperproteinemialead to a negative bias in the meas-urement of electrolyte because ofdilution effect.	Sodium : Serum/plasmaHemolysis: Avoid hemolyzed speci-mens. No significant interference upto 1000 mg/dL of hemoglobinIcterus: No significant interference upto 60 mg/dL bilirubinLipemia: No significant interferenceup to 2000 mg/dL of triglyceridesDysproteinemia: No significant inter-ference up to 3000 mg/dLDrugs: A panel of drugs was testedand caused no significant interfer-ences when added to aliquots ofpooled normal human serum/plasmaup to the indicated concentration.
	Potassium:Unconjugated bilirubin: No signifi-cant interference up to 36 mg/dL (616μmol/L).Conjugated bilirubin: No significantinterference up to 25 mg/dL (427μmol/L).Turbidity: No significant interferenceup 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/plasmaHemolysis: Avoid hemolyzed speci-mens. No significant interference upto 100 mg/dL of hemoglobin. Potas-sium concentration in erythrocytes is25 times higher than in normal plas-ma. The level of interference may bevariable depending on the exact con-tent of erythrocytesIcterus: No significant interference upto 60 mg/dL bilirubin.Lipemia: No significant interferenceup 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 hyperproteinemialead to a negative bias in the meas-urement of electrolyte because ofdilution effect.	Drugs: A panel of drugs was testedand caused no significant interfer-ences when added to aliquots ofpooled normal human serum/plasmaup to the indicated concentration.
	Chloride:Unconjugated bilirubin: No signifi-cant interference up to 36 mg/dL (616µmol/L).Conjugated bilirubin: No significantinterference up to 25 mg/dL (427μmol/L).Turbidity: No significant interferenceup 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 hyperproteinemialead to a negative bias in the meas-urement of electrolyte because ofdilution effect.	Chloride: Serum/plasmaHemolysis: Avoid hemolyzed speci-mens. No significant interference upto 1000 mg/dL of hemoglobin.Icterus: No significant interference upto 60 mg/dL bilirubin.Lipemia: No significant interferenceup to 2000 mg/dL of triglyceridesDysproteinemia: No significant inter-ference up to 3000 mg/dL.Drugs: A panel of drugs was testedand caused no significant interfer-ences when added to aliquots ofpooled normal human serum/plasmaup to the indicated concentration. Inaddition 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 referencematerial :Na+ NIST SRM 919bK+ NIST SRM 918bCl- NIST SRM 918b/919b	This method has been standardizedagainst primary calibrators preparedgravimetrically from purified salts.
Calibration Frequency	It is recommended to recalibrate aftersetting-up of a new vial of ISE Refer-ence Solution or of ISE Diluent thenevery 4 hours when quality controlresults fall outside the establishedrange, after replacing electrode, andafter ISE cleaning and maintenance	24 hours (main calibration) after ISEcleaning and maintenance, afterchanging the reagent bottles afterreplacing electrodes
ISECALIBRATOR	ELITech Clinical Systems Device(ISE Calibrator)	Predicate deviceRoche Standards for the Cobas ISEModule K897071
ISE Calibrators	Composition:Aqueous solutions containing sodium,potassium and chloride with 2 differ-ent levels of concentrations.Concentrations are lot-specific. Thevalues are given in the vial labels.	ISE Calibration kitComposition:Aqueous preparations with differentlevels of concentrations level 1 andlevel 2ISE Solution 1 :Na+ 150 mmol/LK+ 5 mmol/L
	Cl⁻: 115 mmol/LISE Solution 2:Na⁺: 110 mmol/LK⁺: 1.8 mmol/LCl⁻: 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 °CNote: 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 °CNote: Close opened bottles immediately after use and store at 2-8 °C.
	ISE Calibrator indirect /urineComposition:Sodium (Na⁺): 25 mmol/LPotassium (K⁺): 0.83 mmol/LChloride (Cl⁻): 19.2 mmol/LStorage:Store at 15-25 °C. This solution is stable until the expiry date stated on the label.

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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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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).

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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

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510(k) Number (if known): _ K |081047_________________________________________________________________________________________________________________________________________

Device Name: ELITech Clinical Systems Selectra ProM

Indications for Use:

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

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510(k) Number (if known): _ K 102647

Device Name:

Indications for Use:

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

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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

ISE Chloride Electrode

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]

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510(k) Number (if known): _ K |001047

ELITech Clinical Systems ELITROL 1 & ELITROLII_ Device Name:

Indications for Use:

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

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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

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510(k) Number (if known):

Device Name:

Indications for Use:

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]

Regulation Number and Section

§ 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.