ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH by ELITECHGROUP

ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

ELITech Clinical Systems ALBUMIN is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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 ELITech Clinical Systems Selectra analyzers.

ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

Device Description

The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: MES buffer (pH 6.50), Arsenazo III [2,7-(bis(2-arsonophenylazo))-1,8-dihydronaphtalene-3,6-disulphonic acid].

The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: Succinate buffer (pH 4.20), Bromocresol green, Brij 35.

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 FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

ELITech Clinical Systems 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 HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

AI/ML Overview

The provided text describes several in-vitro diagnostic devices (reagents, calibrators, and controls) and their performance characteristics. However, it does not contain information about studies involving AI, human readers, or image analysis. The data provided is for traditional laboratory assays, comparing a new device to a predicate device.

Therefore, many of the requested elements for describing an AI device's acceptance criteria and study are not applicable or cannot be extracted from this document, such as:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Not specified for clinical samples in the context of an AI study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts - Not applicable for chemical assays.
Adjudication method - Not applicable for chemical assays.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance - No AI component described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - No AI component described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Not explicitly stated in terms of expert consensus or pathology for clinical samples, but implied to be analytical results from established methods.
The sample size for the training set - No AI component described, so no training set discussed.
How the ground truth for the training set was established - No AI component described.

Below is an attempt to address the request based only on the information available in the provided text, primarily focusing on the "ELITech Clinical Systems CALCIUM ARSENAZO" reagent as it is the first device detailed.

Acceptance Criteria and Device Performance Study for ELITech Clinical Systems CALCIUM ARSENAZO

The provided document describes the performance characteristics of the ELITech Clinical Systems CALCIUM ARSENAZO reagent, a quantitative in vitro diagnostic device for total calcium in human serum and plasma. The study presented is a comparison to a legally marketed predicate device, Stanbio Calcium LiquiColor® (Arsenazo III) (K921625), to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, where the new device's performance metrics are expected to be comparable or better. The table below summarizes the reported performance of the ELITech Clinical Systems CALCIUM ARSENAZO. Specific numerical acceptance criteria (e.g., "must be ≥X") are not explicitly stated as separate targets, but rather demonstrated through direct comparison to the predicate's known performance or through established analytical performance ranges.

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (ELITech Clinical Systems CALCIUM ARSENAZO)
Intended Use	Quantitative in vitro diagnostic determination of total calcium in human serum and plasma.	Same as predicate.
Measuring Range	Comparable to 0 to 15 mg/dL	5.0 - 15.0 mg/dL
Limit of Detection (LoD)	Not explicitly stated for predicate in summary, but assumed to be very low.	0.36 mg/dL
Limit of Quantification (LoQ)	Not explicitly stated for predicate.	5.00 mg/dL
Precision (Within Run)	Comparable to CV=1.3% (Level 11.0 mg/dL) and CV=0.9% (Level 14.3 mg/dL)	Level 8.75 mg/dL CV= 1.3%Level 9.68 mg/dL CV= 0.9%Level 11.97 mg/dL CV=0.7%
Precision (Total/Run-to-run)	Comparable to CV=1.1% (Level 11.2 mg/dL) and CV=1.3% (Level 14.3 mg/dL)	Level 8.75 mg/dL CV= 1.9%Level 9.68 mg/dL CV= 1.9%Level 11.97 mg/dL CV= 1.9%
Method Comparison	Linear regression parameters and correlation coefficient (r) comparable to y=0.99x+0.10 mg/dL, r=0.989.	y= 1.008x - 0 mg/dLr= 0.996 (range: 4.90 to 14.37 mg/dL)
Interference	Minimal interference from common substances (Hemoglobin, Bilirubin, Lipemia).	Hemoglobin: No significant interference up to 500 mg/dL.Triglycerides: No significant interference up to 1119 mg/dL. A positive bias observed above 1119 mg/dL.Unconjugated bilirubin: No significant interference up to 30.0 mg/dL.Conjugated bilirubin: No significant interference up to 29.5 mg/dL.Magnesium: No significant interference up to 10.91 mg/dL.Ascorbic acid: No significant interference up to 20 mg/dL.Acetaminophen: No significant interference up to 30 mg/dL.Acetylsalicylic acid: No significant interference up to 200 mg/dL.
Calibration Frequency	Comparable to 30 days	28 days
On-board Stability	Comparable to 30 days	28 days

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

The document does not explicitly state the specific sample size for the clinical test set used in method comparison or interference studies. It is described as testing human serum and plasma.
The data provenance (country of origin, retrospective/prospective) is not specified in this summary.

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

Not applicable. This is a chemical assay, not an assessment requiring expert interpretation of images or clinical findings. The "ground truth" for the test set would be established by the predicate device's accepted analytical results, or other reference methods for analytical performance studies.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human adjudication of clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes an in vitro diagnostic reagent; there is no AI component or human reader study involved.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document describes an in vitro diagnostic reagent; there is no algorithm or AI component. The "standalone" performance here refers to the analytical performance of the reagent on the specified analyzer.

7. The Type of Ground Truth Used

For method comparison, the ground truth is established by comparing the results of the ELITech Clinical Systems CALCIUM ARSENAZO with analyses performed using the predicate device (Stanbio Calcium LiquiColor®) on the same samples. For precision, linearity, and interference studies, ground truth would be based on known concentrations or preparations in control materials and spiked samples. This is a form of analytical ground truth.

8. The Sample Size for the Training Set

Not applicable. There is no AI component, and thus no "training set" in the context of machine learning.

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

Not applicable as there is no training set for an AI model. For the analytical studies, ground truth is established through standard laboratory practices for calibrators, controls, and comparative methods.

Summary

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SECTION 5 - 510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination of sub-stantial equivalence.
	The assigned 510(k) number is: K 110830 JUN: 2. 1 2011
Submitter	SEPPIM S.A.S.
Address	Zone Industrielle, 61500 SEES, FRANCE
Phone number	+ 33 (0)2 33 81 21 00
Fax number	+ 33 (0)2 33 28 77 51
Contact	Valérie GOURDON (Email: v.gourdon@elitechgroup.com)
Date of Preparation	March 24th, 2011
Device names
REAGENTTrade/proprietary Name:	ELITech Clinical Systems CALCIUM ARSENAZO
Common or Usual Name:	Calcium, “CALCIUM ARSENAZO”
Device Class	Class II
Classification name	Calcium test system (Sec.862.1145)
Product code	CJY- Azo Dye, Calcium
Predicate device	Stanbio Calcium LiquiColor® (Arsenazo III) (K921625)
Device description	The device for this submission is available as kit only. It consists of 1reagent "R".Reagent R contains: MES buffer (pH 6.50), Arsenazo III [2,7-(bis(2-arsonophenylazo))-1,8-dihydronaphtalene-3,6-disulphonic acid].
Intended Use	ELITech Clinical Systems CALCIUM ARSENAZO is intended for thequantitative in vitro diagnostic determination of total calcium in human serumand plasma on ELITech Clinical Systems Selectra analyzers.It is not intended for use in Point of Care settings.
Indication for use	Calcium measurements are used in the diagnosis and treatment of parathy-roid disease, a variety of bone diseases, chronic renal disease and tetany(intermittent muscular contractions or spasms).
	ELITech Clinical Systems Device(CALCIUM ARSENAZO)	Predicate device(Stanbio Calcium LiquiColor®(Arsenazo III) K921625)
Intended use	Intended for the quantitative in vitrodiagnostic determination of total cal-cium in human serum and plasma onELITech Clinical Systems Selectraanalyzers.It is not intended for use in Point ofCare settings.	For the quantitative colorimetric de-termination of calcium in human serumand plasma on Stanbio LaboratorySirrus Chemistry Analyzer.
Indication for Use	Calcium measurements are used inthe diagnosis and treatment of para-thyroid disease, a variety of bonediseases, chronic renal disease andtetany (intermittent muscular contrac-tions or spasms).	Calcium measurements are used inthe diagnosis and treatment of para-thyroid disease, a variety of bone dis-eases, chronic renal disease and teta-ny (intermittent muscular contractionsor spasms).
Assay protocol	Colorimetric test	Colorimetric test
Composition	Reagent R:MES buffer (pH 6.50) 100 mmol/L ;Arsenazo III 200 µmol/L ;	Reagent :Buffer :Arsenazo III > 0.15 mmol/L ;8-Hydroxyquinoline sulfonate 5.0 mM;Surfactant
Appearance of re-agents	Liquid form, ready to use	Liquid form, ready to use
Sample type	SerumPlasma	SerumPlasma
Reagent storage	Store at 2-8 °C and protect from light.The reagent is stable until the expirydate stated on the label.	Store at 2-30 °C the reagent is stableuntil the expiry date stated on the la-bel.
Expected values	Serum/plasma:8.6 - 10.3 mg/dL	Serum/plasma:8.5 - 10.4 mg/dL
Instrument	Selectra ProM Analyzer	Sirrus Chemistry Analyzer
Measuring range	5.0 - 15.0 mg/dL	0 to 15 mg/dL
Limit of detection(LoD)	0.36 mg/dL
Limit of quantification(LoQ)	5.00 mg/dL
Precision	Within run	Within run
	Level 8.75 mg/dL CV= 1.3%	Level 11.0 mg/dL CV=1.3%
	Level 9.68 mg/dL CV= 0.9%	Level 14.3 mg/dL CV=0.9%
	Level 11.97 mg/dL CV=0.7%
	Total	Run to run
	Level 8.75 mg/dL CV= 1.9%	Level 11.2 mg/dL CV=1.1%
	Level 9.68 mg/dL CV= 1.9%	Level 14.3. mg/dL CV=1.3%
	Level 11.97 mg/dL CV= 1.9%
Method comparison	y= 1.008 x - 0 mg/dLr= 0.996range: 4.90 to 14.37 mg/dL	y= 0.99 x + 0.10 mg/dLr= 0.989range: 4.7 to 15.9 mg/dL
Limitations	Hemoglobin: No significant interfer-ence up to 500 mg/dL.	Bilirubin: No interference up to 20mg/dL.
	ELITech Clinical Systems Device(CALCIUM ARSENAZO)	Predicate device(Stanbio Calcium LiquiColor®(Arsenazo III) K921625)
	Triglycerides: No significant interference up to 1119 mg/dL. A positivebias is observed with triglyceridesconcentratsion above 1119 mg/dL.Unconjugated bilirubin: No signifi-cant interference up to 30.0 mg/dL(513 µmol/L).Conjugated bilirubin: No significantinterference up to 29.5 mg/dL (504µmol/L).Magnesium: No significant interfer-ence up to 10.91 mg/dL.Ascorbic acid: No significant interfer-ence up to 20 mg/dL.Acetaminophen: No significant inter-ference up to 30 mg/dL.Acetylsalicylic acid: No significantinterference up to 200 mg/dL.	Hemoglobin: No interference up to500 mg/dL.Lipemia: May cause elevated results.
Calibration Frequency	28 days	30 days
On board stability	refrigerated area : 28 days	30 days
Calibrator	Recommended calibration material(not included):ELITech Clinical Systems ELICAL 2	Recommended calibration material(not included):Ser-T-Cal® MultiCalibrator
Controls	Recommended quality control material(not included):ELITech Clinical Systems ELITROL I(Normal control)ELITech Clinical Systems ELITROL II(Pathologic control)	Recommended quality control material(not included):Ser-T-Fy® I (Normal control)Ser-T-Fy® II (Abnormal control)

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Device namesREAGENT
Trade/proprietary Name:	ELITech Clinical Systems ALBUMIN
Common or Usual Name:	Albumin, "ALBUMIN"
Device Class	Class II
Classification name	Albumin test system (Sec.862.1035)
Product code	CIX - Bromcresol green dye-binding, Albumin
Predicate device	Roche Diagnostics Albumin Gen.2 (K063744)
Device description	The device for this submission is available as kit only. It consists of 1reagent "R".Reagent R contains: Succinate buffer (pH 4.20), Bromocresol green, Brij 35.
Intended Use	ELITech Clinical Systems ALBUMIN is intended for the quantitative in vitrodiagnostic determination of albumin in human serum and plasma on ELI-Tech Clinical Systems Selectra analyzers. It is not intended for use in Pointof Care settings.
Indication for use	Albumin measurements are used in the diagnosis and treatment of numer-ous diseases involving primarily the liver or kidneys.

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	ELITech Clinical Systems Device(ALBUMIN)	Predicate device(Roche Diagnostics Albumin Gen.2K063744)
Intended use	Intended for the quantitative in vitrodiagnostic determination of albumin inhuman serum and plasma on ELITechClinical Systems Selectra analyzers.It is not intended for use in Point ofCare settings.	For in vitro diagnostic use in the quan-titative determination of albumin inhuman serum and plasma on the co-bas c111 system.
Indication for Use	Albumin measurements are used inthe diagnosis and treatment of numer-ous diseases involving primarily theliver or kidneys.	Albumin measurements are used inthe diagnosis and treatment of numer-ous diseases involving primarily theliver or kidneys.
Assay protocol	Colorimetric test	Colorimetric test
Composition	Reagent R:Succinate buffer (pH 4.20) 87 mmol/L;Bromocresol green 0.2 mmol/L;Brij 35 7.35 mL/L;	Reagent R1:Citrate (pH 4.1) 95 mmol/L;PreservativeReagent R2:Citrate (pH 4.1) 95 mmol/L;Bromocresol green 0.66 mmol/L;Preservative
Appearance of reagents	Liquid form, ready to use	Liquid form, ready for use
Sample type	SerumPlasma	SerumPlasma
Reagent storage	Store at 2-25 °C and protect from light.The reagent is stable until the expirydate stated on the label.	Stored at 15-25 °C.Reagents are stable until the expirydate stated on the label.
Expected values	Serum, plasma:Adults: 3.5-5.2 g/dL60-90 years : 3.2-4.6 g/dL> 90 years: 2.9-4.5 g/dLIn ambulatory patients, values aver-age ~0.3 g/dL higher.	Serum/plasma:Adults (reference range study) : 3.97-4.94 g/dLAdults (consensus values) : 3.5-5.2g/dLTietz:0-4 days : 2.8-4.4 g/dL4 days-14 years: 3.8-5.4 g/dL14 -18 years: 3.2-4.5 g/dL
Instrument	Selectra ProM Analyzer	Cobas c111
Measuring range	1.6 - 6.0 g/dL	0.2 to 6.0 g/dL
Limit of detection(LoD)	0.003 g/dL	0.2 g/dL
Limit of quantification(LoQ)	0.50 g/dL
Precision	Within run	Within run
	Level 2.54 g/dL CV= 0.9%Level 3.53 g/dL CV= 0.5%Level 4.98 g/dL CV= 0.8%	Level 4.67 g/dL CV=0.52%Level 2.99 g/dL CV=0.76%Level 3.01 g/dL CV=0.56%Level 5.48 g/dL CV=0.61%
	Total	Run to run
	ELITech Clinical Systems Device(ALBUMIN)	Predicate device(Roche Diagnostics Albumin Gen.2K063744)
	Level 2.54 g/dL CV= 2.3%Level 3.53 g/dL CV=2.1%Level 4.98 mg/dL CV=2.1%	Level 4.62 g/dL CV=1.87%Level 2.97 g/dL CV=1.45%Level 2.98 g/dL CV=1.83%Level 5.40 g/dL CV=1.24%
Method comparison	y= 0.961x + 0.12 g/dLr= 0.997range: 1.43 to 5.89 g/dL.	y= 1.017 x + 0.0164 g/dLr= 0.9997range: 0.26 to 5.93 g/dL
Limitations	Hemoglobin: No significant interfer-ence up to 500 mg/dL.Triglyceride: No significant interfer-ence up to 3000 mg/dL.Unconjugated bilirubin: No signifi-cant interference up to 30.0 mg/dL(513 µmol/L).Conjugated bilirubin: No significantinterference up to 29.5 mg/dL (504µmol/L).Ascorbic acid: No significant interfer-ence up to 20 mg/dL.Acetaminophen: No significant inter-ference up to 30 mg/dL.Acetylsalicylic acid: No significantinterference up to 200 mg/dL.γ-globulin: No significant interferenceup to 1500 mg/dL.	Hemoglobin: No significant interfer-ence up to an H Index of 420 (ap-proximate 420 mg/dL).Lipemia (Intralipid): No significantinfluence up to an L index of 900.There is poor correlation between theL index (corresponds to turbidity) andtriglycerides concentration.Icterus: No significant influence up toI Index of 60 (approximate conju-gated and unconjugated bilirubin con-centration of 60 mg/dL (1026 µmol/L)).γ-globulin: No significant interference.
Calibration Frequency	28 days	Each lot and as required followingquality control procedures.
On board stability	refrigerated area : 28 days	4 weeks
Calibrator	Recommended calibration material(not included):ELITech Clinical Systems ELICAL 2	Recommended calibration material(not included):Roche Calibrator f.a.s.
Controls	Recommended quality control material(not included):ELITech Clinical Systems ELITROL I(Normal control)ELITech Clinical Systems ELITROL II(Pathologic control)	Recommended quality control material(not included):Roche Precinorm URoche Precipath U

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Device name

CALIBRATOR :
Trade/proprietary Name:	ELITech Clinical Systems ELICAL 2
Common or Usual Name:	Calibrator, multi-analyte mixture, "ELICAL 2"
Device Class	Class II
Classification name	Calibrator (21 CFR 862.1150)
Product code	JIX- Calibrator, multi-analyte mixture

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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 onhuman serum containing constituents to ensure optimal calibration.ELICAL 2 is prepared exclusively from the blood of donors tested individuallyand found to be negative for HbsAg and to antibodies to HCV and HIV ac-cording to FDA-approved methods or methods in compliance with the Euro-pean Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for invitro diagnostic use in the calibration of quantitative ELITech Clinical Sys-tems methods on ELITech Clinical Systems Selectra Analyzers.

Comparison to Predicate device

	ELITech Clinical Systems Device(ELICAL 2)	Predicate device(Roche Calibrator f.a.s. K033501)
Intended use	ELITech Clinical Systems ELICAL2 is a multi-parametric calibratorfor in vitro diagnostic use in thecalibration of quantitative ELITechClinical Systems methods onELITech Clinical Systems Selec-tra Analyzers.	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 lyophilizate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam.	Carefully open one bottle, avoidingthe loss of lyophilizate, and pipettein exactly 3 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional 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 :	After reconstitution, the stabilities*are :
	Between 15-25 °C :8 hours	- 8 hours at 15-25 °C.

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Between 2-8 °C :Between (-25)-(-15) °C : 4 weeks(when frozen once)	2 days	- 2 days at 2-8 °C.- 4 weeks at Between (-25)-(-15) °C(when frozen once)
Exceptions :- Stability of direct bilirubin (whenstored protected from light):		Exception for bilirubin total & direct- Stability of direct bilirubin (whenstored protected from light):
Between 15-25 °C:	3 hours	Between 15-25 °C:	3 hours
Between 2-8 °C:Between (-25)-(-15) °C: 2 weeks(when frozen once)	8 hours	Between 2-8 °CBetween (-25)-(-15) °C: 2 weeks(when frozen once)	8 hours
- Stability of total bilirubin (whenstored protected from light):		- Stability of total bilirubin (whenstored protected from light):
Between 15-25 °C:	6 hours	Between 15-25 °C:	6 hours
Between 2-8 °C:Between (-25)-(-15) °C: 2 weeks(when frozen once)	1 day	Between 2-8 °C:Between (-25)-(-15) °C: 2 weeks(when frozen once)	1 day

Device names

CONTROLS:Trade/proprietary Name:	ELITech Clinical Systems ELITROL I and ELITROL II
Common or Usual Name:	Multi-analyte controls - all kinds, "ELITROL I"- "ELITROL II"
Device Class	Class I
Classification name	Quality control material (assayed and unassayed). (21 CFR 862.1660)
Product code	JJY- 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 qualitycontrol products consisting of lyophilized human serum containing constitu-ents at desired levels.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 andHIV according to FDA-approved methods or methods in compliance with theEuropean Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametriccontrol sera for in vitro diagnostic use in quality control of quantitative ELITechClinical Systems methods on ELITech Clinical Systems Selectra Analyzers.

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	ELITech Clinical Systems Device(ELITROL I / ELITROL II)	Predicate Device(Roche Precinorm U / Precipath UK041227)
Intended use	ELITech Clinical Systems ELITROL I and ELITROL II are multi- parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Sys- tems methods on ELITech Clinical Systems Selectra Analyzers.	For in vitro diagnostic use in quality control by monitoring accuracy and precision for the quantitative.meth- ods as specified in the value sheet
Format	Lyophilized human sera with con- stituents added as required to ob- tain desired components levels	Lyophilized human sera with con- stituents added as required to ob- tain desired components levels
Levels	Two levels	Two levels
Handling	Carefully open the vial, avoiding the loss of lyophilizate, 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 lyophilizate, and pipette in exactly 5 mL of distilled/deionized water. Carefully 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 dateAfter reconstitution, the stabilities are :Between 15-25 °C : 12 hoursBetween 2-8 °C : 5 daysBetween (-25)-(-15) °C : 4 weeks (when frozen once)Exceptions:- Stability of direct bilirubin (when stored protected from light):Between 15-25 °C: 4 hoursBetween 2-8 °C: 8 hoursBetween (-25)-(-15) °C: 2 weeks (when frozen once)- Stability of total bilirubin (when stored protected from light):Between 15-25 °C: 8 hoursBetween 2-8 °C: 1 dayBetween (-25)-(-15) °C: 2 weeks (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 frozen once)*Exception for bilirubin total & direct as noted in package insert:- Stability of direct bilirubin (when stored protected from light):Between 15-25 °C: 4 hoursBetween 2-8 °C: 8 hoursBetween (-25)-(-15) °C: 2 weeks (when frozen once)- Stability of total bilirubin (when stored protected from light):Between 15-25 °C: 8 hoursBetween 2-8 °C: 24 hoursBetween (-25)-(-15) °C: 2 weeks (when frozen once)

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Conclusion The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.

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Device name

CALIBRATOR :Trade/proprietary Name:	ELITech Clinical Systems ELICAL 2
Common or Usual Name:	Calibrator, multi-analyte mixture, "ELICAL 2"
Device Class	Class II
Classification name	Calibrator (21 CFR 862.1150)
Product code	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 onhuman serum containing constituents to ensure optimal calibration.ELICAL 2 is prepared exclusively from the blood of donors tested individuallyand found to be negative for HbsAg and to antibodies to HCV and HIVaccording to FDA-approved methods or methods in compliance with theEuropean Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for invitro diagnostic use in the calibration of quantitative ELITech ClinicalSystems methods on ELITech Clinical Systems Selectra Analyzers.

	ELITech Clinical Systems Device(ELICAL 2)	Predicate device(Roche Calibrator f.a.s. K033501)
Intended use	ELITech Clinical Systems ELICAL2 is a multi-parametric calibratorfor in vitro diagnostic use in thecalibration of quantitative ELITechClinical Systems methods onELITech Clinical SystemsSelectra Analyzers.	For in vitro diagnostic use in thecalibration of quantitative Rochemethods on Roche clinicalchemistry analysers as specified inthe value 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 lyophilizate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam.	Carefully open one bottle, avoidingthe loss of lyophilizate, and pipettein exactly 3 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional 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

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. •

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 :	After reconstitution, the stabilities*are :
	Between 15-25 °C :8 hours	- 8 hours at 15-25 °C.
	Between 2-8 °C :2 daysBetween (-25)-(-15) °C : 4 weeks(when frozen once)	- 2 days at 2-8 °C.- 4 weeks at Between (-25)-(-15) °C(when frozen once)
	Exceptions :- Stability of direct bilirubin (whenstored protected from light):	Exception for bilirubin total & direct- Stability of direct bilirubin (whenstored protected from light):
	Between 15-25 °C:3 hours	Between 15-25 °C:3 hours
	Between 2-8 °C:8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)	Between 2-8 °C8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)
	- Stability of total bilirubin (whenstored protected from light):	- Stability of total bilirubin (whenstored protected from light):
	Between 15-25 °C:6 hours	Between 15-25 °C:6 hours
	Between 2-8 °C:1 dayBetween (-25)-(-15) °C: 2 weeks(when frozen once)	Between 2-8 °C:1 dayBetween (-25)-(-15) °C: 2 weeks(when frozen once)

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Device names

CONTROLS:Trade/proprietary Name:	ELITech Clinical Systems ELITROL I and ELITROL II
Common or Usual Name:	Multi-analyte controls - all kinds, "ELITROL I"- "ELITROL II"
Device Class	Class I
Classification name	Quality control material (assayed and unassayed). (21 CFR 862.1660)
Product code	JJY- 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 qualitycontrol products consisting of lyophilized human serum containingconstituents at desired levels.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 andHIV according to FDA-approved methods or methods in compliance with theEuropean Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametriccontrol sera for in vitro diagnostic use in quality control of quantitative ELITechClinical Systems methods on ELITech Clinical Systems Selectra Analyzers.

	ELITech Clinical Systems Device(ELITROL I / ELITROL II)	Predicate Device(Roche Precinorm U / Precipath UK041227)
Intended use	ELITech Clinical Systems ELITROLI and ELITROL II are multi-parametric control sera for in vitrodiagnostic use in quality control ofquantitative ELITech ClinicalSystems methods on ELITechClinical Systems SelectraAnalyzers.	For in vitro diagnostic use in qualitycontrol by monitoring accuracy andprecision for the quantitativemethods as specified in the valuesheet
Format	Lyophilized human sera withconstituents added as required toobtain desired components levels	Lyophilized human sera withconstituents added as required toobtain desired components levels
Levels	Two levels	Two levels
Handling	Carefully open the vial, avoiding theloss of lyophilizate, and pipette inexactly 5 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam.	Carefully open the bottle, avoidingthe loss of lyophilizate, and pipettein exactly 5 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation offoam.
Stability	Lyophilized:To store at 2-8°C and protectedfrom light until the expiry date	Lyophilized:Stable at 2-8°C up to expirationdate

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ELITech Clinical Systems Device(ELITROL I/ ELITROL II)	Predicate Device(Roche Precinorm U/ Precipath UK041227)
After reconstitution, the stabilitiesare:Between 15-25 °C:12 hoursBetween 2-8 °C:5 daysBetween (-25)-(-15) °C: 4 weeks(when frozen once)Exceptions:- Stability of direct bilirubin (whenstored protected from light):Between 15-25 °C:4 hoursBetween 2-8 °C:8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)- Stability of total bilirubin (whenstored protected from light):Between 15-25 °C:8 hoursBetween 2-8 °C:1 dayBetween (-25)-(-15) °C: 2 weeks(when frozen once)	After reconstitution, the stabilitiesare:- 12 hours at 15-25 °C.- 5 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once)Exception for bilirubin total & directas noted in package insert:- Stability of direct bilirubin (whenstored protected from light):Between 15-25 °C:4 hoursBetween 2-8 °C:8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)- Stability of total bilirubin (whenstored protected from light):Between 15-25 °C:8 hoursBetween 2-8 °C:24 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)

ELITech Clinical Systems Device(ELITROL I/ ELITROL II)

Predicate Device(Roche Precinorm U/ Precipath UK041227)

After reconstitution, the stabilitiesare:Between 15-25 °C:12 hoursBetween 2-8 °C:5 daysBetween (-25)-(-15) °C: 4 weeks(when frozen once)Exceptions:- Stability of direct bilirubin (whenstored protected from light):Between 15-25 °C:4 hoursBetween 2-8 °C:8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)- Stability of total bilirubin (whenstored protected from light):Between 15-25 °C:8 hoursBetween 2-8 °C:1 dayBetween (-25)-(-15) °C: 2 weeks(when frozen once)

After reconstitution, the stabilities*are:- 12 hours at 15-25 °C.- 5 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once)*Exception for bilirubin total & directas noted in package insert:- Stability of direct bilirubin (whenstored protected from light):Between 15-25 °C:4 hoursBetween 2-8 °C:8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)- Stability of total bilirubin (whenstored protected from light):Between 15-25 °C:8 hoursBetween 2-8 °C:24 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)

Conclusion

The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/13/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

SEPPIM S.A.S. Elitech Group Epoch Biosciences c/o Ms. Debra Hutson Director, Quality Assurance/Regulatory Affairs 21720 23rd Drive, S.E., Suite 150 Bothell, Washington 98021

Food & Drug Administration 10903 New Hampshire Avenue Building 66 · Silver Spring, MD 20993

JAN 21 2011

K110830 Re:

Trade Name: ELITech Clinical Systems Albumin, ELITech Clinical Systems Calcium Arsenazo, ELITech Clinical Systems Elical 2, ELITech Clinical Systems Elitrol I and II Regulation Number: 21 CFR §862.1035

Regulation Name: Albumin Test System

Regulatory Class: Class II Product Codes: CIX, CJY, JIX, JJY Dated: May 18, 2011 Received: May 19, 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 III (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

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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 and Safety at (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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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): KIIO 830

ELITech Clinical Systems CALCIUM ARSENAZO Device Name:

Indications for Use:

ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra analyzers.

It is not intended for use in Point of Care settings.

Calcium measurements are used in the diagnosis and treatment of parathyroid disease. a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

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)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110830

Page 1 of 4

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510(k) Number (if known): K ||0830

ELITech Clinical Systems ALBUMIN Device Name:

Indications for Use:

ELITech Clinical Systems ALBUMIN is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma on ELITech Clinical Systems Selectra analyzers.

It is not intended for use in Point of Care settings.

Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

P.i.i.g. on

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 1<-110830

Pag

{17}------------------------------------------------

510(k) Number (if known): KID830

ELITech Clinical Systems ELICAL 2 Device Name:

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

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) |<110 & 30

Page 3 of 4

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510(k) Number (if known): KI|0830

ELITech Clinical Systems ELITROL I & ELITROL II Device Name:

Indications for Use:

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

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)

CARLOS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 110830

Page4 of 4

Regulation Number and Section

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.