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

K110830 · Elitechgroup · CIX · Jun 21, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110830
• Device Name: ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
• Applicant: Elitechgroup
• Product Code: CIX · Clinical Chemistry
• Decision Date: Jun 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended 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. 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. 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 and 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 Story

The ELITech Clinical Systems suite includes colorimetric reagents for calcium and albumin, a lyophilized multi-analyte calibrator (ELICAL 2), and two-level lyophilized controls (ELITROL I/II). These are intended for use on ELITech Clinical Systems Selectra analyzers in clinical laboratory settings. The calcium assay uses Arsenazo III dye-binding; the albumin assay uses Bromocresol green dye-binding. The system processes human serum or plasma samples. Healthcare providers use the quantitative results to diagnose and monitor parathyroid, bone, renal, and liver/kidney conditions. The calibrator and controls ensure assay accuracy and precision. The device is not for point-of-care use.

Clinical Evidence

Bench testing only. Performance validated per CLSI guidelines (EP5-A2, EP6-A, EP7-A2, EP9-A2, EP17-A). Precision studies showed total CVs of 1.9-2.3%. Linearity confirmed across 1.6-6.0 g/dL (Albumin) and 5.0-15.0 mg/dL (Calcium). Method comparison against predicates yielded R² values ≥ 0.972. Interference testing identified positive bias for Calcium with triglycerides > 1119 mg/dL.

Technological Characteristics

Colorimetric assays using Arsenazo III (calcium) and Bromocresol green (albumin). Reagents are liquid, ready-to-use. Calibrator and controls are lyophilized human serum-based. Analyzers: Selectra ProM. Calibration frequency: 28 days. Storage: 2-8°C (reagents/calibrator/controls).

Indications for Use

Indicated for: Calcium measurements used in diagnosis/treatment of parathyroid disease, bone diseases, chronic renal disease, and tetany. Albumin measurements used in diagnosis/treatment of liver or kidney diseases. Calibrator and controls used for calibration and quality control of quantitative assays on Selectra analyzers.

Regulatory Classification

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.

Predicate Devices

• Stanbio Calcium LiquiColor (Arsenazo III) (k921625)
• Roche Diagnostics Albumin Gen.2 (k063744)
• Roche Diagnostics Calibrator for Automated Systems (k033501)
• Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera (k041227)

Submission Summary (Full Text)

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## SECTION 5 - 510(k) Summary

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| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of sub-<br>stantial equivalence. | |
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| | 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: [e-mail]) | |
| Date of Preparation | March 24th, 2011 | |
| Device names | | |
| REAGENT<br>Trade/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 1<br>reagent "R".<br>Reagent R contains: MES buffer (pH 6.50), Arsenazo III [2,7-(bis(2-<br>arsonophenylazo))-1,8-dihydronaphtalene-3,6-disulphonic acid]. | |
| Intended Use | ELITech Clinical Systems CALCIUM ARSENAZO is intended for the<br>quantitative <i>in vitro</i> diagnostic determination of total calcium in human serum<br>and plasma on ELITech Clinical Systems Selectra analyzers.<br>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-<br>roid disease, a variety of bone diseases, chronic renal disease and tetany<br>(intermittent muscular contractions or spasms). | |
| | ELITech Clinical Systems Device<br>(CALCIUM ARSENAZO) | Predicate device<br>(Stanbio Calcium LiquiColor®<br>(Arsenazo III) K921625) |
| Intended use | Intended for the quantitative <i>in vitro</i><br>diagnostic determination of total cal-<br>cium in human serum and plasma on<br>ELITech Clinical Systems Selectra<br>analyzers.<br>It is not intended for use in Point of<br>Care settings. | For the quantitative colorimetric de-<br>termination of calcium in human serum<br>and plasma on Stanbio Laboratory<br>Sirrus Chemistry Analyzer. |
| Indication for Use | Calcium measurements are used in<br>the diagnosis and treatment of para-<br>thyroid disease, a variety of bone<br>diseases, chronic renal disease and<br>tetany (intermittent muscular contrac-<br>tions or spasms). | Calcium measurements are used in<br>the diagnosis and treatment of para-<br>thyroid disease, a variety of bone dis-<br>eases, chronic renal disease and teta-<br>ny (intermittent muscular contractions<br>or spasms). |
| Assay protocol | Colorimetric test | Colorimetric test |
| Composition | Reagent R:<br>MES buffer (pH 6.50) 100 mmol/L ;<br>Arsenazo III 200 µmol/L ; | Reagent :<br>Buffer :<br>Arsenazo III > 0.15 mmol/L ;<br>8-Hydroxyquinoline sulfonate 5.0 mM;<br>Surfactant |
| Appearance of re-agents | Liquid form, ready to use | Liquid form, ready to use |
| Sample type | Serum<br>Plasma | Serum<br>Plasma |
| Reagent storage | Store at 2-8 °C and protect from light.<br>The reagent is stable until the expiry<br>date stated on the label. | Store at 2-30 °C the reagent is stable<br>until the expiry date stated on the la-<br>bel. |
| Expected values | Serum/plasma:<br>8.6 - 10.3 mg/dL | Serum/plasma:<br>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<br>(LoD) | 0.36 mg/dL | |
| Limit of quantification<br>(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/dL<br>r= 0.996<br>range: 4.90 to 14.37 mg/dL | y= 0.99 x + 0.10 mg/dL<br>r= 0.989<br>range: 4.7 to 15.9 mg/dL |
| Limitations | Hemoglobin: No significant interfer-<br>ence up to 500 mg/dL. | Bilirubin: No interference up to 20<br>mg/dL. |
| | ELITech Clinical Systems Device<br>(CALCIUM ARSENAZO) | Predicate device<br>(Stanbio Calcium LiquiColor®<br>(Arsenazo III) K921625) |
| | <b>Triglycerides:</b> No significant interference up to 1119 mg/dL. A positive<br>bias is observed with triglycerides<br>concentratsion above 1119 mg/dL.<br><b>Unconjugated bilirubin:</b> No signifi-<br>cant interference up to 30.0 mg/dL<br>(513 µmol/L).<br><b>Conjugated bilirubin:</b> No significant<br>interference up to 29.5 mg/dL (504<br>µmol/L).<br><b>Magnesium:</b> No significant interfer-<br>ence up to 10.91 mg/dL.<br><b>Ascorbic acid:</b> No significant interfer-<br>ence up to 20 mg/dL.<br><b>Acetaminophen:</b> No significant inter-<br>ference up to 30 mg/dL.<br><b>Acetylsalicylic acid:</b> No significant<br>interference up to 200 mg/dL. | <b>Hemoglobin:</b> No interference up to<br>500 mg/dL.<br><b>Lipemia:</b> May cause elevated results. |
| Calibration Frequency | 28 days | 30 days |
| On board stability | refrigerated area : 28 days | 30 days |
| Calibrator | Recommended calibration material<br>(not included):<br>ELITech Clinical Systems ELICAL 2 | Recommended calibration material<br>(not included):<br>Ser-T-Cal® MultiCalibrator |
| Controls | Recommended quality control material<br>(not included):<br>ELITech Clinical Systems ELITROL I<br>(Normal control)<br>ELITech Clinical Systems ELITROL II<br>(Pathologic control) | Recommended quality control material<br>(not included):<br>Ser-T-Fy® I (Normal control)<br>Ser-T-Fy® II (Abnormal control) |

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| Device names<br>REAGENT | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 1<br>reagent "R".<br>Reagent R contains: Succinate buffer (pH 4.20), Bromocresol green, Brij 35. |
| Intended Use | ELITech Clinical Systems ALBUMIN is intended for the quantitative <i>in vitro</i><br>diagnostic determination of albumin in human serum and plasma on ELI-<br>Tech Clinical Systems Selectra analyzers. It is not intended for use in Point<br>of Care settings. |
| Indication for use | Albumin measurements are used in the diagnosis and treatment of numer-<br>ous diseases involving primarily the liver or kidneys. |

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| | ELITech Clinical Systems Device<br>(ALBUMIN) | Predicate device<br>(Roche Diagnostics Albumin Gen.2<br>K063744) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Intended for the quantitative <i>in vitro</i><br>diagnostic determination of albumin in<br>human serum and plasma on ELITech<br>Clinical Systems Selectra analyzers.<br>It is not intended for use in Point of<br>Care settings. | For <i>in vitro</i> diagnostic use in the quan-<br>titative determination of albumin in<br>human serum and plasma on the co-<br>bas c111 system. |
| Indication for Use | Albumin measurements are used in<br>the diagnosis and treatment of numer-<br>ous diseases involving primarily the<br>liver or kidneys. | Albumin measurements are used in<br>the diagnosis and treatment of numer-<br>ous diseases involving primarily the<br>liver or kidneys. |
| Assay protocol | Colorimetric test | Colorimetric test |
| Composition | Reagent R:<br>Succinate buffer (pH 4.20) 87 mmol/L;<br>Bromocresol green 0.2 mmol/L;<br>Brij 35 7.35 mL/L; | Reagent R1:<br>Citrate (pH 4.1) 95 mmol/L;<br>Preservative<br><br>Reagent R2:<br>Citrate (pH 4.1) 95 mmol/L;<br>Bromocresol green 0.66 mmol/L;<br>Preservative |
| Appearance of reagents | Liquid form, ready to use | Liquid form, ready for use |
| Sample type | Serum<br>Plasma | Serum<br>Plasma |
| Reagent storage | Store at 2-25 °C and protect from light.<br>The reagent is stable until the expiry<br>date stated on the label. | Stored at 15-25 °C.<br>Reagents are stable until the expiry<br>date stated on the label. |
| Expected values | Serum, plasma:<br>Adults: 3.5-5.2 g/dL<br>60-90 years : 3.2-4.6 g/dL<br>> 90 years: 2.9-4.5 g/dL<br>In ambulatory patients, values aver-<br>age ~0.3 g/dL higher. | Serum/plasma:<br>Adults (reference range study) : 3.97-<br>4.94 g/dL<br>Adults (consensus values) : 3.5-5.2<br>g/dL<br>Tietz:<br>0-4 days : 2.8-4.4 g/dL<br>4 days-14 years: 3.8-5.4 g/dL<br>14 -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<br>(LoD) | 0.003 g/dL | 0.2 g/dL |
| Limit of quantification<br>(LoQ) | 0.50 g/dL | |
| Precision | Within run | Within run |
| | Level 2.54 g/dL CV= 0.9%<br>Level 3.53 g/dL CV= 0.5%<br>Level 4.98 g/dL CV= 0.8% | Level 4.67 g/dL CV=0.52%<br>Level 2.99 g/dL CV=0.76%<br>Level 3.01 g/dL CV=0.56%<br>Level 5.48 g/dL CV=0.61% |
| | Total | Run to run |
| | ELITech Clinical Systems Device<br>(ALBUMIN) | Predicate device<br>(Roche Diagnostics Albumin Gen.2<br>K063744) |
| | Level 2.54 g/dL CV= 2.3%<br>Level 3.53 g/dL CV=2.1%<br>Level 4.98 mg/dL CV=2.1% | Level 4.62 g/dL CV=1.87%<br>Level 2.97 g/dL CV=1.45%<br>Level 2.98 g/dL CV=1.83%<br>Level 5.40 g/dL CV=1.24% |
| Method comparison | y= 0.961x + 0.12 g/dL<br>r= 0.997<br>range: 1.43 to 5.89 g/dL. | y= 1.017 x + 0.0164 g/dL<br>r= 0.9997<br>range: 0.26 to 5.93 g/dL |
| Limitations | <b>Hemoglobin:</b> No significant interfer-<br>ence up to 500 mg/dL.<br><b>Triglyceride:</b> No significant interfer-<br>ence up to 3000 mg/dL.<br><b>Unconjugated bilirubin:</b> No signifi-<br>cant interference up to 30.0 mg/dL<br>(513 µmol/L).<br><b>Conjugated bilirubin:</b> No significant<br>interference up to 29.5 mg/dL (504<br>µmol/L).<br><b>Ascorbic acid:</b> No significant interfer-<br>ence up to 20 mg/dL.<br><b>Acetaminophen:</b> No significant inter-<br>ference up to 30 mg/dL.<br><b>Acetylsalicylic acid:</b> No significant<br>interference up to 200 mg/dL.<br><b>γ-globulin:</b> No significant interference<br>up to 1500 mg/dL. | <b>Hemoglobin:</b> No significant interfer-<br>ence up to an H Index of 420 (ap-<br>proximate 420 mg/dL).<br><b>Lipemia (Intralipid):</b> No significant<br>influence up to an L index of 900.<br>There is poor correlation between the<br>L index (corresponds to turbidity) and<br>triglycerides concentration.<br><b>Icterus:</b> No significant influence up to<br>I Index of 60 (approximate conju-<br>gated and unconjugated bilirubin con-<br>centration of 60 mg/dL (1026 µmol/L)).<br><b>γ-globulin:</b> No significant interference. |
| Calibration Frequency | 28 days | Each lot and as required following<br>quality control procedures. |
| On board stability | refrigerated area : 28 days | 4 weeks |
| Calibrator | Recommended calibration material<br>(not included):<br>ELITech Clinical Systems ELICAL 2 | Recommended calibration material<br>(not included):<br>Roche Calibrator f.a.s. |
| Controls | Recommended quality control material<br>(not included):<br>ELITech Clinical Systems ELITROL I<br>(Normal control)<br>ELITech Clinical Systems ELITROL II<br>(Pathologic control) | Recommended quality control material<br>(not included):<br>Roche Precinorm U<br>Roche 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 on<br>human serum containing constituents to ensure optimal calibration.<br>ELICAL 2 is prepared exclusively from the blood of donors tested individually<br>and found to be negative for HbsAg and to antibodies to HCV and HIV ac-<br>cording to FDA-approved methods or methods in compliance with the Euro-<br>pean Directive 98/79/EC, Annex II, List A. |
| Intended Use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in<br>vitro diagnostic use in the calibration of quantitative ELITech Clinical Sys-<br>tems methods on ELITech Clinical Systems Selectra Analyzers. |

### Comparison to Predicate device…