ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS

K100263 · Seppim S.A.S. · CEO · May 6, 2011 · Clinical Chemistry

Device Facts

• Record ID: K100263
• Device Name: ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
• Applicant: Seppim S.A.S.
• Product Code: CEO · Clinical Chemistry
• Decision Date: May 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1580
• Device Class: Class 1

Intended Use

ELITech Clinical Systems PHOSPHORUS reagent is for the quantitative in vitro diagnostic determination of inorganic phosphorus in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. ELITech Clinical Systems URIC ACID MONO SL reagent is for the quantitative in vitro diagnostic determination of uric acid in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. ELITech Clinical Systems UREA UV SL reagent is for the quantitative in vitro diagnostic determination of urea nitrogen in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. 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 Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.

Device Story

System includes three clinical chemistry reagents (Phosphorus, Uric Acid, Urea) plus calibrator (ELICAL 2) and controls (ELITROL I & II). Reagents are liquid, ready-to-use. Phosphorus assay uses phosphomolybdate UV method; Uric Acid uses enzymatic Trinder method (uricase/peroxidase); Urea uses enzymatic UV method (urease/glutamate dehydrogenase). Device operates on Vital Scientific Selectra/Flexor Junior analyzers in clinical laboratory settings. Input: human serum or lithium heparin plasma. Output: quantitative concentration values displayed to laboratory personnel. Results assist clinicians in diagnosing/monitoring renal, metabolic, and parathyroid conditions. System requires professional operation; not for point-of-care use.

Clinical Evidence

Bench testing only. Performance validated via precision (CLSI EP5-A2), linearity (CLSI EP6-A), and method comparison (CLSI EP9-A2) against predicate devices using 100 patient samples per analyte. Results showed high correlation (r > 0.99) and acceptable precision (CVs < 3%). Interference studies defined limitations for turbidity, hemolysis, and specific drugs.

Technological Characteristics

Lyophilized human serum calibrators/controls; liquid, ready-to-use reagents. Urea: Urease/GIDH enzymatic UV. Phosphorus: Phosphomolybdate colorimetric. Uric Acid: Uricase/Peroxidase enzymatic (Trinder). Analyzers: Vital Scientific Selectra/Flexor. Storage: 2-8°C.

Indications for Use

Indicated for: 1) ELICAL 2: Calibration of quantitative ELITech Clinical Systems methods. 2) UREA UV SL: Measurement of urea nitrogen in human serum/plasma for diagnosis/treatment of renal and metabolic diseases. 3) PHOSPHORUS: Measurement of inorganic phosphorus in human serum/plasma for diagnosis/treatment of parathyroid/kidney diseases and vitamin D imbalance. 4) URIC ACID MONO SL: Measurement of uric acid in human serum/plasma for diagnosis/treatment of renal/metabolic disorders (e.g., gout, leukemia, renal failure). 5) ELITROL I/II: Accuracy control for quantitative ELITech Clinical Systems methods. All devices are for prescription use only; not for Point of Care.

Regulatory Classification

Identification

A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Predicate Devices

• Roche Calibrator f.a.s. (K033501)
• ABX PENTRA UREA CP (K060205, K070146)
• ABX PENTRA PHOSPHORUS CP (K060205, K070249)
• ABX PENTRA Uric acid CP (K060205, K081276)
• Roche Diagnostics Precinorm U (K041227)
• Roche Diagnostics Precipath U (K041227)

Submission Summary (Full Text)

{0}------------------------------------------------

### SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELICAL 2 MAY - 6 2011

| Introduction | According to the requirements of 21 CFR 807.92, the following<br>information provides sufficient detail to understand the basis for a<br>determination of substantial equivalence. | | ELITech Clinical Systems Device<br>(ELICAL 2) | Predicate device<br>(Roche Calibrator f.a.s.) |
|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The assigned 510(k) number is: K100263 | Intended use | ELITech Clinical Systems ELICAL<br>2 is a multi-parametric calibrator<br>for <i>in vitro</i> diagnostic use in the<br>calibration of quantitative ELITech<br>Clinical Systems methods on the<br>Vital Scientific Selectra Junior<br>Analyzer and the Vital Scientific<br>Flexor Junior Analyzer. | For <i>in vitro</i> diagnostic use in the<br>calibration of quantitative Roche<br>methods on Roche clinical<br>chemistry analysers as specified in<br>the value sheets. |
| Submitter<br>Address<br>Phone number<br>Fax number | SEPPIM S.A.S.<br>Zone Industrielle, 61500 SEES, FRANCE<br>+ 33 (0)2 33 81 21 00<br>+ 33 (0)2 33 28 77 51 | Format | Lyophilized calibrator based on<br>human serum with constituents<br>added as required to obtain desired<br>components levels | Lyophilized calibrator based on<br>human serum with constituents<br>added as required to obtain desired<br>components levels |
| Contact | Valérie GOURDON (Email: [e-mail]) | Level | Single level | Single level |
| Date of Preparation | Friday, January 22nd 2010 | Handling | Carefully open the vial, avoiding the<br>loss of lyophilate, and pipette in<br>exactly 3 mL of distilled/deionized<br>water. Carefully close the vial and<br>dissolve the contents completely by<br>occasional gentle swirling within 30<br>minutes avoiding the formation of<br>foam. | Carefully open one bottle, avoiding<br>the loss of lyophilate, and pipette in<br>exactly 3 mL of distilled/deionized<br>water. Carefully close the bottle and<br>dissolve the contents completely by<br>occasional gentle swirling within 30<br>minutes. Avoid the formation of<br>foam. |
| Trade/proprietary Name:<br>Common or Usual Name:<br>Device Class<br>Classification name<br>Product code | ELITech Clinical Systems ELICAL 2<br>Calibrator, multi-analyte mixture, "ELICAL 2"<br>Class II<br>Calibrator (21 CFR 862.1150)<br>JIX- Calibrator, multi-analyte mixture | Traceability | Traceability information is given in<br>the value sheet included in the box. | Traceability of the target value is<br>given in the respective instruction<br>for use of the system reagents. |
| Predicate device | Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)<br>(K033501) | Stability | Lyophilized:<br>To store at 2-8°C and protected<br>from light until the expiry date | Lyophilized:<br>Stable at 2-8°C up to expiration<br>date. |
| Device description | ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human<br>serum containing constituents to ensure optimal calibration.<br>ELICAL 2 is prepared exclusively from the blood of donors tested individually and<br>found to be negative for HbsAg and to antibodies to HCV and HIV according to<br>FDA-approved methods or methods in compliance with the European Directive<br>98/79/EC, Annex II, List A. | | After reconstitution, the stabilities<br>are:<br>- 8 hours between 15-25 °C.<br>- 2 days between 2-8 °C.<br>- 4 weeks between -25 and -15 °C<br>(when frozen once) | After reconstitution, the stabilities*<br>are:<br>- 8 hours at 15-25 °C.<br>- 2 days at 2-8 °C.<br>- 4 weeks at (-25)-(-15) °C (when<br>frozen once) |
| Intended Use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for <i>in vitro</i><br>diagnostic use in the calibration of quantitative ELITech Clinical Systems<br>methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific<br>Flexor Junior Analyzer. | | | *Exception for bilirubin total & direct<br>as noted in package insert |

{1}------------------------------------------------

### Comparison to Predicate device

### 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 device.

{2}------------------------------------------------

## SECTION 5 - 510(k) Summary ELITech Clinical Systems UREA UV SL reagent

| 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<br>substantial equivalence. | | ELITech Clinical Systems Device<br>UREA UV SL | Predicate device<br>(ABX PENTRA UREA CP) |
|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The assigned 510(k) number is: K100263 | Intended Use | Intended for use with ELITech<br>Clinical Systems ELICAL 2 and<br>ELITech Clinical Systems ELITROL I<br>and ELITROL II on Vital Scientific<br>Selectra/Flexor analyzers for the<br>quantitative <i>in vitro</i> diagnostic<br>determination of urea nitrogen in<br>human serum and plasma.<br>It is not intended for use in Point of<br>Care settings. | For <i>in vitro</i> diagnostic use in the<br>quantitative determination of<br>urea/urea nitrogen in serum, plasma<br>and urine. |
| Submitter<br>Address<br>Phone number<br>Fax number | SEPPIM S.A.S.<br>Zone Industrielle, 61500 SEES, FRANCE<br>+ 33 (0)2 33 81 21 00<br>+ 33 (0)2 33 28 77 51 | Indication(s) for Use | Intended to measure urea nitrogen<br>in human serum and plasma. Urea<br>nitrogen measurements are used in<br>the diagnosis and treatment of<br>certain renal and metabolic<br>diseases. | Urea nitrogen measurements are<br>used in the diagnosis and treatment<br>of certain renal and metabolic<br>diseases. |
| Contact | Valérie GOURDON (Email: [e-mail]) | Assay protocol | Enzymatic UV method using Urease<br>and Glutamate dehydrogenase | Enzymatic UV method using Urease<br>and Glutamate dehydrogenase |
| Date of Preparation | Friday, January 22nd 2010 | Composition | Reagent R1:<br>Tris buffer, pH 7.60 125 mmol/L;<br>ADP 1 mmol/L;<br>α-Ketoglutarate 9 mmol/L;<br>Urease ≥ 8 100 U/L;<br>GIDH ≥ 1 350 U/L;<br>Sodium azide < 0.1%;<br><br>Reagent R2:<br>NADH 1.5 mmol/L;<br>Sodium azide < 0.1%; | Reagent 1:<br>Tris buffer, pH 7.8 150 mmol/L;<br>2-Oxoglutarate 8.75 mmol/L;<br>ADP 0.75 mmol/L;<br>Urease ≥ 7 500 U/L;<br>GIDH ≥ 1 250 U/L;<br>Sodium azide < 1 g/L;<br><br>Reagent 2:<br>NADH 1.32 mmol/L;<br>Sodium azide < 1 g/L; |
| Device names | | Appearance of reagent | Liquid form, ready to use | Liquid form, ready to use |
| REAGENT :<br>Trade/proprietary Name:<br>Common or Usual Name:<br>Device Class<br>Classification name<br>Product code | ELITech Clinical Systems UREA UV SL<br>Urea nitrogen, "UREA UV SL"<br>Class II<br>Urea nitrogen test system (Sec.862.1770)<br>CDQ - Urease And Glutamic Dehydrogenase, Urea Nitrogen | Sample type | Serum<br>Plasma in lithium heparin | Serum<br>Plasma in lithium heparin<br>Urine |
| Predicate device | ABX PENTRA UREA CP (K060205, K070146) | Reagent storage | Store at 2-8 °C and protected from<br>light. The reagents are stable until<br>the expiry date stated on the label. | Reagents, in unopened cassette, are<br>stable up to expiry date on the label<br>if stored at 2-8 °C and contamination<br>avoided. |
| Device description | The device for this submission is available as kit only. It consists of 2 reagents:<br>Reagent 1 contains Tris buffer (pH 7.60), Adenosine diphosphate potassium salt<br>(ADP), α-Ketoglutarate, Urease (jack bean), Glutamate dehydrogenase (GIDH)<br>(bovine liver) and sodium azide.<br>Reagent 2 contains NADH and sodium azide | Expected values | Serum, plasma:<br><b>Urea nitrogen (BUN)</b><br>Adults (21-60 years) 6-20 mg/dL<br>Adults (60-90 years) 8-23 mg/dL<br>Adults (> 90 years) 10-31 mg/dL | Serum, plasma:<br><b>Urea nitrogen (BUN)</b><br>Adults:<br>Global : 7.9-20.2 mg/dL<br>Women < 50 years 7.3-18.8 mg/dL<br>Women > 50 years 9.8-20.2 mg/dL<br>Men < 50 years 9.0-20.5 mg/dL<br>Men > 50 years 8.4-25.8 mg/dL<br>Children:<br>1-3 years 5.1-16.8 mg/dL |
| Intended Use | ELITech Clinical Systems UREA UV SL is intended for use with ELITech Clinical<br>Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II on<br>Vital Scientific Selectra/Flexor analyzers for the quantitative <i>in vitro</i> diagnostic<br>determination of urea nitrogen in human serum and plasma.<br>It is not intended for use in Point of Care settings. | | | |
| Indication(s) for Use | ELITech Clinical Systems UREA UV SL is intended to measure urea nitrogen in<br>human serum and plasma. Urea nitrogen measurements are used in the<br>diagnosis and treatment of certain renal and metabolic diseases. | | | |

{3}------------------------------------------------

### Comparison to Predicate device

{4}------------------------------------------------

------

| | ELITech Clinical Systems Device<br>UREA UV SL | Predicate device<br>(ABX PENTRA UREA CP) |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | 14-19 years<br>8.1-21.1 mg/dL |
| Instrument | SELECTRA JUNIOR | ABX PENTRA 400 |
| Measuring range* | 4.7 to 140.0 mg/dL<br>Extended measuring range : 140.0 to 670.0 mg/dL | 1.03 to 140.3 mg/dL<br>Automatic post-dilution: 701.5 mg/dL |
| Limit of detection (LoD)* | 0.3 mg/dL | |
| Limit of quantification (LoQ)* | 2.3 mg/dL | 0.9 mg/dL |
| Precision* | Within run<br>Level 7.3 mg/dL CV=2.1%<br>Level 29.2 mg/dL CV=0.8%<br>Level 72.4 mg/dL CV=0.7%<br><br>Total<br>Level 7.3 mg/dL CV=2.8%<br>Level 29.2 mg/dL CV=1.3%<br>Level 72.4 mg/dL CV=1.6% | Within run<br>Level 18.7 mg/dL CV=2.27%<br>Level 72.8 mg/dL CV=1.66%<br>Level 6.0 mg/dL CV=2.76%<br>Level 20.9 mg/dL CV=1.58%<br>Level 85.5 mg/dL CV=1.80%<br><br>Total<br>Level 18.5 mg/dL CV=2.14%<br>Level 71.7 mg/dL CV=1.93%<br>Level 19.2 mg/dL CV=2.14%<br>Level 70.1 mg/dL CV=1.97% |
| Method comparison* | y=0.991 x + 0.6 mg/dL<br>r= 0.999<br>range: 4.4 to 139.8 mg/dL | y=0.99 x - 0.06 mg/dL<br>r²= 0.996<br>range: 1.03 to 138.89 mg/dL |
| Limitations | Hemoglobin: No significant interference up to 500 mg/dL.<br>Turbidity: No significant interference up to 614 mg/dL triglyceride equivalent.<br>Unconjugated bilirubin: No significant interference up to 30 mg/dL.<br>Conjugated bilirubin: No significant interference up to 29.5 mg/dL.<br>Ascorbic acid: No significant interference up to 20 mg/dL.<br>Methyldopa: No significant interference up to 1 mg/dL. | Hemoglobin: No significant influence is observed up to 460 mg/dL.<br>Triglycerides: No significant influence is observed up to 612.5 mg/dL.<br>Total bilirubin: No significant influence is observed up to 22.23 mg/dL.<br>Direct bilirubin: No significant influence is observed up to 23.40 mg/dL. |
| Calibration Frequency | 7 days | 8 days |
| On board stability | refrigerated area : 14 days | refrigerated area: 70 days |
| Calibrator | Recommended calibration material (not included):<br>ELITech Clinical Systems Elical 2 | Recommended calibration material (not included):<br>ABX Pentra Multical |
| Controls | Recommended quality control material (not included):<br>ELITech Clinical Systems Elitrol I | Recommended quality control material (not included):<br>ABX Pentra N Control |
| ELITech Clinical Systems Device<br>UREA UV SL | Predicate device:<br>(ABX PENTRA UREA CP) | |
| (Normal control) | (Normal control) | |
| ELITech Clinical Systems Elitrol II<br>(Pathologic control) | ABX Pentra P Control (Pathologic<br>control) | |

{5}------------------------------------------------

* : values expressed in BUN

#### The performance data and other information demonstrate that the safety and Conclusion 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 device.

{6}------------------------------------------------

## SECTION 5 - 510(k) Summary ELITech Clinical Systems PHOSPHORUS reagent

| | | | ELITech Clinical Systems Device<br>PHOSPHORUS | Predicate device<br>(ABX PENTRA PHOSPHORUS CP) |
|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>substantial equivalence. | Intended use | Intended for use with ELITech<br>Clinical Systems ELICAL 2 and<br>ELITech Clinical Systems ELITROL I<br>and ELITROL II on Vital Scientific<br>Selectra/Flexor analyzers for the<br>quantitative <i>in vitro</i> diagnostic<br>determination of inorganic<br>phosphorus in human serum and<br>plasma. It is not intended for use in<br>Point of Care settings. | For <i>in vitro</i> diagnostic use in the<br>quantitative determination of<br>phosphorus in serum, plasma and<br>urine. |
| | The assigned 510(k) number is: K100263 | Indication for Use | Intended to measure inorganic<br>phosphorus in human serum and<br>plasma. (Inorganic) phosphorus<br>measurements are used in the<br>diagnosis and treatment of various<br>disorders, including parathyroid<br>gland and kidney diseases, and<br>vitamin D imbalance. | Measurements of phosphorus<br>(inorganic) are used in the diagnosis<br>and treatment of various disorders,<br>including parathyroid gland and<br>kidney diseases, and vitamin D<br>imbalance. |
| Submitter<br>Address<br>Phone number<br>Fax number | SEPPIM S.A.S.<br>Zone Industrielle, 61500 SEES, FRANCE<br>+ 33 (0)2 33 81 21 00<br>+ 33 (0)2 33 28 77 51 | Assay protocol | UV method using<br>phosphomolybdate | UV method using<br>phosphomolybdate |
| Contact | Valérie GOURDON (Email: [e-mail]) | Composition | Reagent R:<br>Sulfuric acid 210 mmol/L;<br>Ammonium molybdate 650 µmol/L : | Reagent:<br>Sulfuric acid 210 mmol/L;<br>Ammonium molybdate 650 µmol/L; |
| Date of Preparation | Friday, January 22nd 2010 | Appearance of reagent | Liquid form, ready to use | Liquid form, ready to use |
| Device names | | Sample type | Serum<br>Plasma in lithium heparin | Serum<br>Plasma in lithium heparin<br>Urine |
| REAGENT :<br>Trade/proprietary Name:<br>Common or Usual Name:<br>Device Class<br>Classification name<br>Product code | ELITech Clinical Systems PHOSPHORUS<br>Inorganic phosphorus, "PHOSPHORUS"<br>Class I<br>Phosphorus (inorganic) test system (Sec.862.1580)<br>CEO - Phosphomolybdate (colorimetric), inorganic phosphorus | Reagent storage | Store at 2-25 °C and protected from<br>light. The reagent is stable until the<br>expiry date stated on the label. | Reagents, in unopened cassette, are<br>stable up to expiry date on the label<br>if stored at 2-8 °С. |
| Predicate device | ABX PENTRA PHOSPHORUS CP (K060205, K070249) | Expected values | Serum, plasma : 2.7 - 4.5 mg/dL | Serum, plasma : 2.7 - 4.5 mg/dL |
| Device description | The device for this submission is available as kit only. It consists of 1 reagent R.<br>Reagent R consists of sulfuric acid and ammonium molybdate. | Instrument | SELECTRA JUNIOR | ABX PENTRA 400 |
| Intended Use | ELITech Clinical Systems PHOSPHORUS is intended for use with ELITech<br>Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and<br>ELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitative <i>in</i><br><i>vitro</i> diagnostic determination of inorganic phosphorus in human serum and<br>plasma. It is not intended for use in Point of Care settings. | Measuring range | 2.0 to 20.0 mg/dL | 0.30 to 24.18 mg/dL<br>Automatic post-dilution: 96.72 mg/dL |
| Indication(s) for Use | ELITech Clinical Systems PHOSPHORUS is intended to measure inorganic<br>phosphorus in human serum and plasma. (Inorganic) phosphorus<br>measurements are used in the diagnosis and treatment of various disorders,<br>including parathyroid gland and kidney diseases, and vitamin D imbalance. | Limit of detection (LoD) | 0.02 mg/dL | 0.28 mg/dL |
| Limit of quantification (LoQ) | 1.00 mg/dL | | | |
| Precision | Within run<br>Level 2.37 mg/dL CV=1.1%<br>Level 4.80 mg/dL CV=1.5%<br>Level 9.55 mg/dL CV=1.7% | Within run<br>Level 4.08 mg/dL CV=1.25%<br>Level 6.34 mg/dL CV=0.77%<br>Level 2.39 mg/dL CV=2.48%<br>Level 3.48 mg/dL CV=1.61%<br>Level 9.19 mg/dL CV=1.38% | | |

{7}------------------------------------------------

### Comparison to Predicate device

{8}------------------------------------------------

| | ELITech Clinical Systems Device<br>PHOSPHORUS | Predicate device<br>(ABX PENTRA PHOSPHORUS CP) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Total | Level 2.37 mg/dL CV=1.9%<br>Level 4.80 mg/dL CV=1.7%<br>Level 9.55 mg/dL CV=2.2% | Total<br>Level 4.01 mg/dL CV=2.50%<br>Level 6.35 mg/dL CV=1.82%<br>Level 2.50 mg/dL CV=3.56%<br>Level 11.44 mg/dL CV=1.38% |
| Method comparison | y=0.999 - 0.09 mg/dL<br>r= 0.999<br>range: 2.02 to 20.08 mg/dL | y=1.04x + 0.15 mg/dL<br>r2= 0.998<br>range: 0.30 to 24.08 mg/dL |
| Limitations | Hemoglobin: No significant<br>interference is observed up to 50<br>mg/dL. Unconjugated bilirubin: No<br>significant interference is observed<br>up to 15 mg/dL<br>Conjugated bilirubin: No significant<br>interference is observed up to 1.5<br>mg/dL.<br>Glucose: No significant interference<br>is observed up to 500 mg/dL.<br>Triglycerides: No significant<br>interference is observed up to 732<br>mg/dL. | Hemoglobin: No significant<br>influence is observed up to 125<br>mg/dL.<br>Triglycerides: No significant<br>influence is observed up to 262.5<br>mg/dL.<br>Total bilirubin: No significant<br>influence is observed up to 6 mg/dL.<br>Direct bilirubin: No significant<br>influence is observed up to 25<br>mg/dL. |
| Calibration Frequency | 28 days | 34 days |
| On board stability | refrigerated area : 28 days | refrigerated area: 70 days |
| Calibrator | Recommended calibration material<br>(not included):<br>ELITech Clinical Systems Elical 2 | Recommended calibration material<br>(not included):<br>ABX Pentra Multical |
| Controls | Recommended quality control<br>material (not included):<br>ELITech Clinical Systems Elitrol I<br>(Normal control)<br>ELITech Clinical Systems Elitrol II<br>(Pathologic control) | Recommended quality control<br>material (not included):<br>ABX Pentra N Control<br>(Normal control)<br>ABX Pentra P Control (Pathologic<br>control) |

#### 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 device.

{9}------------------------------------------------

## SECTION 5 - 510(k) Summary ELITech Clinical Systems URIC ACID MONO SL reagent

| | | | ELITech Clinical Systems Device.<br>URIC ACID MONO SL | Predicate device :<br>(ABX PENTRA URIC ACID CP) | |
|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| 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<br>substantial equivalence. | | Intended use | Intended for use with ELITech<br>Clinical Systems ELICAL 2 and<br>ELITech Clinical Systems ELITROL I<br>and ELITROL II on Vital Scientific<br>Selectra/Flexor analyzers for the<br>quantitative <i>in vitro</i> diagnostic<br>determination of uric acid in human<br>serum and plasma.<br>It is not intended for use in Point of<br>Care settings. | For <i>in vitro</i> diagnostic use in the<br>quantitative determination of uric<br>acid in serum, plasma and urine. |
| | The assigned 510(k) number is: K100263 | Indication(s) for Use | Intended to measure uric acid in<br>human serum and plasma. Uric acid<br>measurements are used in the<br>diagnosis and treatment of<br>numerous renal and metabolic<br>disorders, including renal failure,<br>gout, leukemia, psoriasis, starvation<br>or other wasting conditions, and of<br>patients receiving cytotoxic drugs. | Uric acid measurements are used in the<br>diagnosis and treatment of<br>numerous renal and metabolic<br>disorders, including renal failure,<br>gout, leukemia, psoriasis, starvation<br>or other wasting conditions, and of<br>patients receiving cytotoxic drugs. | |
| Submitter<br>Address<br>Phone number<br>Fax number | SEPPIM S.A.S.<br>Zone Industrielle, 61500 SEES, FRANCE<br>+ 33 (0)2 33 81 21 00<br>+ 33 (0)2 33 28 77 51 | Assay protocol | Enzymatic determination using a<br>chromgenic system in the presence<br>of peroxidase and uricase (Trinder<br>method). | Enzymatic determination using a<br>chromgenic system in the presence<br>of peroxidase and uricase (Trinder<br>method). | |
| Contact | Valérie GOURDON (Email: [e-mail]) | Composition | Reagent R:<br>Phosphate buffer; pH 7.0 $100 mmol/L$ ;<br>EHSPT $0.72 mmol/L$ ;<br>Ferrocyanide $0.03 mmol/L$ ;<br>Amino-4-antipyrine $0.37 mmol/L$ ;<br>Uricase $\geq 150 U/L$ ;<br>Peroxidase $\geq 12 000 U/L$ ;<br>Sodium azide $< 0.1%$ ; | Reagent 1:<br>Phosphate buffer, pH 7.0 $125 mmol/L$ ;<br>EHSPT $1.38 mmol/L$ ;<br>Ascorbate oxidase $\geq 1 100 U/L$ ;<br>Bovine albumin $0.2 %$ ;<br>Sodium azide $< 0.1%$ ;<br>Reagent 2:<br>4-Aminoantipyrine $1.8 mmol/L$ ;<br>Uricase $\geq 700 U/L$ ;<br>Peroxidase $\geq 7 500 U/L$<br>Ferrocyanide $250 \mu mol/L$ ;<br>Bovine albumin $0.2%$ :<br>Sodium azide $< 0.1%$ : | |
| Date of Preparation | Friday, January 22nd 2010 | | Appearance of reagent | Liquid form, ready to use | Liquid form, ready to use |
| Device names | | Sample type | Serum<br>Plasma in lithium heparin | Serum<br>Plasma in lithium heparin<br>Urine | |
| REAGENT :<br>Trade/proprietary Name:<br>Common or Usual Name:<br>Device Class<br>Classification name<br>Product code | ELITech Clinical Systems URIC ACID MONO SL<br>Uric acid, "URIC ACID MONO SL"<br>Class I<br>Uric acid test system (Sec.862.1775)<br>KNK - Acid, Uric, Uricase (colorimetric) | Reagent storage | Store at 2-8 °C and protected from<br>light. The reagent is stable until the<br>expiry date stated on the label. | Reagents, in unopened cassette, are<br>stable up to expiry date on the label<br>if stored at 2-8 °C. | |
| Predicate device | ABX PENTRA Uric acid CP (K060205, K081276) | Expected values | Serum, plasma<br>Women: 2.6 - 6.0 mg/dL<br>Men: 3.5 - 7.2 mg/dL | Serum, plasma<br>Women: 2.6 - 6.0 mg/dL<br>Men: 3.5 - 7.2 mg/dL | |
| Device description | The device for this submission is available as kit only. It consists of 1 reagent R.<br>Reagent R consists of Phosphate buffer (pH 7.0), N-Ethyl-N-(2-Hydroxy-3-<br>Sulfopropyl) m-Toluidine (EHSPT), Ferrocyanide, Amino-4-antipyrine (4-AAP),<br>Uricase (microorganisms), Peroxidase (horseradich) and sodium azide. | | | | |
| Intended Use | ELITech Clinical Systems URIC ACID MONO SL is intended for use with<br>ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I<br>and ELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitative<br><i>in vitro</i> diagnostic determination of uric acid in human serum and plasma.<br>It is not intended for use in Point of Care settings. | | |…