(463 days)
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.
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.
The device for this submission is available as kit only. It consists of 2 reagents: Reagent 1 contains Tris buffer (pH 7.60), Adenosine diphosphate potassium salt (ADP), alpha-Ketoglutarate, Urease (jack bean), Glutamate dehydrogenase (GIDH) (bovine liver) and sodium azide. Reagent 2 contains NADH and sodium azide
The device for this submission is available as kit only. It consists of 1 reagent R. Reagent R consists of sulfuric acid and ammonium molybdate.
The device for this submission is available as kit only. It consists of 1 reagent R. Reagent R consists of Phosphate buffer (pH 7.0), N-Ethyl-N-(2-Hydroxy-3-Sulfopropyl) m-Toluidine (EHSPT), Ferrocyanide, Amino-4-antipyrine (4-AAP), Uricase (microorganisms), Peroxidase (horseradich) and sodium azide.
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.
The provided text describes several in vitro diagnostic (IVD) devices: ELITech Clinical Systems ELICAL 2 (calibrator), ELITech Clinical Systems UREA UV SL (reagent), ELITech Clinical Systems PHOSPHORUS (reagent), ELITech Clinical Systems URIC ACID MONO SL (reagent), and ELITech Clinical Systems ELITROL I and ELITROL II (controls).
The studies performed for these devices are primarily method comparison and precision studies, focusing on demonstrating substantial equivalence to predicate devices rather than proving a specific clinical utility through a multi-reader multi-case study or a standalone algorithm performance study.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate devices. The performance metrics presented are directly compared.
For ELITech Clinical Systems UREA UV SL (K100263):
| Performance Metric | Acceptance Criteria (Predicate: ABX PENTRA UREA CP) | Reported Device Performance (ELITech Clinical Systems UREA UV SL) |
|---|---|---|
| Measuring Range | 1.03 to 140.3 mg/dL (Automatic post-dilution: 701.5 mg/dL) | 4.7 to 140.0 mg/dL (Extended measuring range: 140.0 to 670.0 mg/dL) |
| Limit of Detection (LoD) | Not explicitly stated | 0.3 mg/dL |
| Limit of Quantification (LoQ) | 0.9 mg/dL | 2.3 mg/dL |
| Precision | ||
| Within Run (Level 7.3 mg/dL) | 2.27% (for 18.7 mg/dL) | CV=2.1% |
| Within Run (Level 29.2 mg/dL) | 1.66% (for 72.8 mg/dL) | CV=0.8% |
| Within Run (Level 72.4 mg/dL) | 2.76% (for 6.0 mg/dL) etc. | CV=0.7% |
| Total (Level 7.3 mg/dL) | 2.14% (for 18.5 mg/dL) | CV=2.8% |
| Total (Level 29.2 mg/dL) | 1.93% (for 71.7 mg/dL) | CV=1.3% |
| Total (Level 72.4 mg/dL) | 2.14% (for 19.2 mg/dL) etc. | CV=1.6% |
| Method Comparison | y=0.99 x - 0.06 mg/dL, r²=0.996, range: 1.03 to 138.89 mg/dL | y=0.991 x + 0.6 mg/dL, r=0.999, range: 4.4 to 139.8 mg/dL |
| Interference (Hemoglobin) | No significant influence up to 460 mg/dL | No significant interference up to 500 mg/dL |
| Interference (Triglycerides) | No significant influence up to 612.5 mg/dL | No significant interference up to 614 mg/dL triglyceride equivalent |
| Interference (Total Bilirubin) | No significant influence up to 22.23 mg/dL | No significant interference up to 30 mg/dL (unconjugated) / 29.5 mg/dL (conjugated) |
| Calibration Frequency | 8 days | 7 days |
| On-board Stability | 70 days | 14 days |
For ELITech Clinical Systems PHOSPHORUS (K100263):
| Performance Metric | Acceptance Criteria (Predicate: ABX PENTRA PHOSPHORUS CP) | Reported Device Performance (ELITech Clinical Systems PHOSPHORUS) |
|---|---|---|
| Measuring Range | 0.30 to 24.18 mg/dL (Automatic post-dilution: 96.72 mg/dL) | 2.0 to 20.0 mg/dL |
| Limit of Detection (LoD) | 0.28 mg/dL | 0.02 mg/dL |
| Limit of Quantification (LoQ) | Not explicitly stated | 1.00 mg/dL |
| Precision | ||
| Within Run (Level 2.37 mg/dL) | 1.25% (for 4.08 mg/dL) | CV=1.1% |
| Within Run (Level 4.80 mg/dL) | 0.77% (for 6.34 mg/dL) | CV=1.5% |
| Within Run (Level 9.55 mg/dL) | 2.48% (for 2.39 mg/dL) etc. | CV=1.7% |
| Total (Level 2.37 mg/dL) | 2.50% (for 4.01 mg/dL) | CV=1.9% |
| Total (Level 4.80 mg/dL) | 1.82% (for 6.35 mg/dL) | CV=1.7% |
| Total (Level 9.55 mg/dL) | 3.56% (for 2.50 mg/dL) etc. | CV=2.2% |
| Method Comparison | y=1.04x + 0.15 mg/dL, r²=0.998, range: 0.30 to 24.08 mg/dL | y=0.999 - 0.09 mg/dL, r=0.999, range: 2.02 to 20.08 mg/dL |
| Interference (Hemoglobin) | No significant influence up to 125 mg/dL | No significant interference up to 50 mg/dL |
| Interference (Triglycerides) | No significant influence up to 262.5 mg/dL | No significant interference up to 732 mg/dL |
| Interference (Total Bilirubin) | No significant influence up to 6 mg/dL | No significant interference up to 15 mg/dL (unconjugated) / 1.5 mg/dL (conjugated) |
| Calibration Frequency | 34 days | 28 days |
| On-board Stability | 70 days | 28 days |
For ELITech Clinical Systems URIC ACID MONO SL (K100263):
| Performance Metric | Acceptance Criteria (Predicate: ABX PENTRA URIC ACID CP) | Reported Device Performance (ELITech Clinical Systems URIC ACID MONO SL) |
|---|---|---|
| Measuring Range | 0.18 to 25.00 mg/dL (Automatic post-dilution: 75.00 mg/dL) | 1.5 to 25.0 mg/dL (Extended measuring range: 25 to 78 mg/dL) |
| Limit of Detection (LoD) | 0.19 mg/dL | 0.02 mg/dL |
| Limit of Quantification (LoQ) | Not explicitly stated | 0.50 mg/dL |
| Precision | ||
| Within Run (Level 2.49 mg/dL) | 0.45% (for 4.62 mg/dL) | CV=0.8% |
| Within Run (Level 5.19 mg/dL) | 0.34% (for 11.63 mg/dL) | CV=1.3% |
| Within Run (Level 7.63 mg/dL) | 1.24% (for 2.53 mg/dL) etc. | CV=1.1% |
| Total (Level 2.49 mg/dL) | 2.81% (for 4.64 mg/dL) | CV=2.6% |
| Total (Level 5.19 mg/dL) | 1.39% (for 11.73 mg/dL) | CV=2.0% |
| Total (Level 7.63 mg/dL) | 2.64% (for 4.67 mg/dL) etc. | CV=2.1% |
| Method Comparison | y=0.95 x + 0.09 mg/dL, r²=0.996, range: 0.18 to 23.59 mg/dL | y=1.015 x + 0.03 mg/dL, r=0.999, range: 1.49 to 24.40 mg/dL |
| Interference (Hemoglobin) | No significant influence up to 500 mg/dL | No significant interference up to 50 mg/dL |
| Interference (Triglycerides) | No significant influence up to 612.5 mg/dL | No significant interference up to 1070 mg/dL |
| Interference (Total Bilirubin) | No significant influence up to 36 mg/dL | No significant interference up to 30 mg/dL (unconjugated) / 14.8 mg/dL (conjugated) |
| Calibration Frequency | 15 days | 28 days |
| On-board Stability | 41 days | 28 days |
2. Sample size used for the test set and the data provenance
- UREA UV SL: The method comparison study gives a range of 4.4 to 139.8 mg/dL for the device. The R-value of 0.999 implies a good correlation across the study range. While a specific number of samples isn't explicitly stated, the R-value is usually calculated from a sufficiently large set of patient samples spanning the analytical range. The data provenance is not stated (e.g., country of origin, retrospective/prospective), but it is implied to be clinical samples used for method comparison.
- PHOSPHORUS: The method comparison study gives a range of 2.02 to 20.08 mg/dL for the device. The R-value of 0.999 implies a good correlation. Similar to UREA UV SL, the number of samples is not explicitly stated, and data provenance is not provided but implied to be clinical samples.
- URIC ACID MONO SL: The method comparison study gives a range of 1.49 to 24.40 mg/dL for the device. The R-value of 0.999 implies a good correlation. The number of samples is not explicitly stated, and data provenance is not provided but implied to be clinical samples.
For ELICAL 2, ELITROL I, ELITROL II: These are calibrators and controls; their performance is validated through stability studies and their intended use in calibrating and controlling assays. No "test set" in the sense of patient samples for diagnostic performance is applicable here. The device description for ELICAL 2, ELITROL I, and ELITROL II mentions they 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." This suggests human-derived materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are in vitro diagnostic devices for quantitative measurements, not imaging or subjective diagnostic interpretations requiring expert consensus for ground truth. "Ground truth" in this context refers to the measured values obtained by the predicate device or a reference method for the method comparison studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication.
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 is an in vitro diagnostic device, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is an IVD reagent and calibrator kit, not an algorithm. The performance data presented (e.g., precision, method comparison, LoD, LoQ) represents the "standalone" analytical performance of the device on the specified analyzer (Selectra Junior/Flexor Junior).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the method comparison studies is the quantitative result obtained from the predicate device (ABX PENTRA UREA CP, ABX PENTRA PHOSPHORUS CP, ABX PENTRA URIC ACID CP) or a reference method assumed to be the "truth" for those studies. For precision studies, there isn't an external "ground truth" but rather a measure of the device's own reproducibility.
8. The sample size for the training set
Not applicable. These are traditional IVD reagents and calibrators, not machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set for a machine learning algorithm is involved.
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SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELICAL 2 MAY - 6 2011
| Introduction | According to the requirements of 21 CFR 807.92, the followinginformation provides sufficient detail to understand the basis for adetermination of substantial equivalence. | ELITech Clinical Systems Device(ELICAL 2) | Predicate device(Roche Calibrator f.a.s.) | |
|---|---|---|---|---|
| The assigned 510(k) number is: K100263 | Intended use | ELITech Clinical Systems ELICAL2 is a multi-parametric calibratorfor in vitro diagnostic use in thecalibration of quantitative ELITechClinical Systems methods on theVital Scientific Selectra JuniorAnalyzer and the Vital ScientificFlexor Junior Analyzer. | For in vitro diagnostic use in thecalibration of quantitative Rochemethods on Roche clinicalchemistry analysers as specified inthe value sheets. | |
| SubmitterAddressPhone numberFax number | SEPPIM S.A.S.Zone Industrielle, 61500 SEES, FRANCE+ 33 (0)2 33 81 21 00+ 33 (0)2 33 28 77 51 | 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 |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Level | Single level | Single level |
| Date of Preparation | Friday, January 22nd 2010 | Handling | Carefully open the vial, avoiding theloss of lyophilate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam. | Carefully open one bottle, avoidingthe loss of lyophilate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation offoam. |
| Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems ELICAL 2Calibrator, multi-analyte mixture, "ELICAL 2"Class IICalibrator (21 CFR 862.1150)JIX- Calibrator, multi-analyte mixture | 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. |
| Predicate device | Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)(K033501) | Stability | Lyophilized:To store at 2-8°C and protectedfrom light until the expiry date | Lyophilized:Stable at 2-8°C up to expirationdate. |
| Device description | ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on humanserum containing constituents to ensure optimal calibration.ELICAL 2 is prepared exclusively from the blood of donors tested individually andfound to be negative for HbsAg and to antibodies to HCV and HIV according toFDA-approved methods or methods in compliance with the European Directive98/79/EC, Annex II, List A. | After reconstitution, the stabilitiesare:- 8 hours between 15-25 °C.- 2 days between 2-8 °C.- 4 weeks between -25 and -15 °C(when frozen once) | After reconstitution, the stabilities*are:- 8 hours at 15-25 °C.- 2 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once) | |
| Intended Use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitrodiagnostic use in the calibration of quantitative ELITech Clinical Systemsmethods on the Vital Scientific Selectra Junior Analyzer and the Vital ScientificFlexor Junior Analyzer. | *Exception for bilirubin total & directas noted in package insert |
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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.
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SECTION 5 - 510(k) Summary ELITech Clinical Systems UREA UV SL reagent
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | ELITech Clinical Systems DeviceUREA UV SL | Predicate device(ABX PENTRA UREA CP) | |
|---|---|---|---|---|
| The assigned 510(k) number is: K100263 | Intended Use | Intended for use with ELITechClinical Systems ELICAL 2 andELITech Clinical Systems ELITROL Iand ELITROL II on Vital ScientificSelectra/Flexor analyzers for thequantitative in vitro diagnosticdetermination of urea nitrogen inhuman serum and plasma.It is not intended for use in Point ofCare settings. | For in vitro diagnostic use in thequantitative determination ofurea/urea nitrogen in serum, plasmaand urine. | |
| SubmitterAddressPhone numberFax number | SEPPIM S.A.S.Zone Industrielle, 61500 SEES, FRANCE+ 33 (0)2 33 81 21 00+ 33 (0)2 33 28 77 51 | Indication(s) for Use | Intended to measure urea nitrogenin human serum and plasma. Ureanitrogen measurements are used inthe diagnosis and treatment ofcertain renal and metabolicdiseases. | Urea nitrogen measurements areused in the diagnosis and treatmentof certain renal and metabolicdiseases. |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Assay protocol | Enzymatic UV method using Ureaseand Glutamate dehydrogenase | Enzymatic UV method using Ureaseand Glutamate dehydrogenase |
| Date of Preparation | Friday, January 22nd 2010 | Composition | Reagent R1:Tris buffer, pH 7.60 125 mmol/L;ADP 1 mmol/L;α-Ketoglutarate 9 mmol/L;Urease ≥ 8 100 U/L;GIDH ≥ 1 350 U/L;Sodium azide < 0.1%;Reagent R2:NADH 1.5 mmol/L;Sodium azide < 0.1%; | Reagent 1:Tris buffer, pH 7.8 150 mmol/L;2-Oxoglutarate 8.75 mmol/L;ADP 0.75 mmol/L;Urease ≥ 7 500 U/L;GIDH ≥ 1 250 U/L;Sodium azide < 1 g/L;Reagent 2:NADH 1.32 mmol/L;Sodium azide < 1 g/L; |
| Device names | Appearance of reagent | Liquid form, ready to use | Liquid form, ready to use | |
| REAGENT :Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems UREA UV SLUrea nitrogen, "UREA UV SL"Class IIUrea nitrogen test system (Sec.862.1770)CDQ - Urease And Glutamic Dehydrogenase, Urea Nitrogen | Sample type | SerumPlasma in lithium heparin | SerumPlasma in lithium heparinUrine |
| Predicate device | ABX PENTRA UREA CP (K060205, K070146) | Reagent storage | Store at 2-8 °C and protected fromlight. The reagents are stable untilthe expiry date stated on the label. | Reagents, in unopened cassette, arestable up to expiry date on the labelif stored at 2-8 °C and contaminationavoided. |
| Device description | The device for this submission is available as kit only. It consists of 2 reagents:Reagent 1 contains Tris buffer (pH 7.60), Adenosine diphosphate potassium salt(ADP), α-Ketoglutarate, Urease (jack bean), Glutamate dehydrogenase (GIDH)(bovine liver) and sodium azide.Reagent 2 contains NADH and sodium azide | Expected values | Serum, plasma:Urea nitrogen (BUN)Adults (21-60 years) 6-20 mg/dLAdults (60-90 years) 8-23 mg/dLAdults (> 90 years) 10-31 mg/dL | Serum, plasma:Urea nitrogen (BUN)Adults:Global : 7.9-20.2 mg/dLWomen < 50 years 7.3-18.8 mg/dLWomen > 50 years 9.8-20.2 mg/dLMen < 50 years 9.0-20.5 mg/dLMen > 50 years 8.4-25.8 mg/dLChildren:1-3 years 5.1-16.8 mg/dL |
| Intended Use | ELITech Clinical Systems UREA UV SL is intended for use with ELITech ClinicalSystems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II onVital Scientific Selectra/Flexor analyzers for the quantitative in vitro diagnosticdetermination of urea nitrogen in human serum and plasma.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 inhuman serum and plasma. Urea nitrogen measurements are used in thediagnosis and treatment of certain renal and metabolic diseases. |
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Comparison to Predicate device
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| ELITech Clinical Systems DeviceUREA UV SL | Predicate device(ABX PENTRA UREA CP) | |
|---|---|---|
| 14-19 years8.1-21.1 mg/dL | ||
| Instrument | SELECTRA JUNIOR | ABX PENTRA 400 |
| Measuring range* | 4.7 to 140.0 mg/dLExtended measuring range : 140.0 to 670.0 mg/dL | 1.03 to 140.3 mg/dLAutomatic 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 runLevel 7.3 mg/dL CV=2.1%Level 29.2 mg/dL CV=0.8%Level 72.4 mg/dL CV=0.7%TotalLevel 7.3 mg/dL CV=2.8%Level 29.2 mg/dL CV=1.3%Level 72.4 mg/dL CV=1.6% | Within runLevel 18.7 mg/dL CV=2.27%Level 72.8 mg/dL CV=1.66%Level 6.0 mg/dL CV=2.76%Level 20.9 mg/dL CV=1.58%Level 85.5 mg/dL CV=1.80%TotalLevel 18.5 mg/dL CV=2.14%Level 71.7 mg/dL CV=1.93%Level 19.2 mg/dL CV=2.14%Level 70.1 mg/dL CV=1.97% |
| Method comparison* | y=0.991 x + 0.6 mg/dLr= 0.999range: 4.4 to 139.8 mg/dL | y=0.99 x - 0.06 mg/dLr²= 0.996range: 1.03 to 138.89 mg/dL |
| Limitations | Hemoglobin: No significant interference up to 500 mg/dL.Turbidity: No significant interference up to 614 mg/dL triglyceride equivalent.Unconjugated bilirubin: No significant interference up to 30 mg/dL.Conjugated bilirubin: No significant interference up to 29.5 mg/dL.Ascorbic acid: No significant interference up to 20 mg/dL.Methyldopa: No significant interference up to 1 mg/dL. | Hemoglobin: No significant influence is observed up to 460 mg/dL.Triglycerides: No significant influence is observed up to 612.5 mg/dL.Total bilirubin: No significant influence is observed up to 22.23 mg/dL.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):ELITech Clinical Systems Elical 2 | Recommended calibration material (not included):ABX Pentra Multical |
| Controls | Recommended quality control material (not included):ELITech Clinical Systems Elitrol I | Recommended quality control material (not included):ABX Pentra N Control |
| ELITech Clinical Systems DeviceUREA UV SL | Predicate device:(ABX PENTRA UREA CP) | |
| (Normal control) | (Normal control) | |
| ELITech Clinical Systems Elitrol II(Pathologic control) | ABX Pentra P Control (Pathologiccontrol) |
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- : 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.
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SECTION 5 - 510(k) Summary ELITech Clinical Systems PHOSPHORUS reagent
| ELITech Clinical Systems DevicePHOSPHORUS | Predicate device(ABX PENTRA PHOSPHORUS CP) | |||
|---|---|---|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | Intended use | Intended for use with ELITechClinical Systems ELICAL 2 andELITech Clinical Systems ELITROL Iand ELITROL II on Vital ScientificSelectra/Flexor analyzers for thequantitative in vitro diagnosticdetermination of inorganicphosphorus in human serum andplasma. It is not intended for use inPoint of Care settings. | For in vitro diagnostic use in thequantitative determination ofphosphorus in serum, plasma andurine. |
| The assigned 510(k) number is: K100263 | Indication for Use | Intended to measure inorganicphosphorus in human serum andplasma. (Inorganic) phosphorusmeasurements are used in thediagnosis and treatment of variousdisorders, including parathyroidgland and kidney diseases, andvitamin D imbalance. | Measurements of phosphorus(inorganic) are used in the diagnosisand treatment of various disorders,including parathyroid gland andkidney diseases, and vitamin Dimbalance. | |
| SubmitterAddressPhone numberFax number | SEPPIM S.A.S.Zone Industrielle, 61500 SEES, FRANCE+ 33 (0)2 33 81 21 00+ 33 (0)2 33 28 77 51 | Assay protocol | UV method usingphosphomolybdate | UV method usingphosphomolybdate |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Composition | Reagent R:Sulfuric acid 210 mmol/L;Ammonium molybdate 650 µmol/L : | Reagent:Sulfuric acid 210 mmol/L;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 | SerumPlasma in lithium heparin | SerumPlasma in lithium heparinUrine | |
| REAGENT :Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems PHOSPHORUSInorganic phosphorus, "PHOSPHORUS"Class IPhosphorus (inorganic) test system (Sec.862.1580)CEO - Phosphomolybdate (colorimetric), inorganic phosphorus | Reagent storage | Store at 2-25 °C and protected fromlight. The reagent is stable until theexpiry date stated on the label. | Reagents, in unopened cassette, arestable up to expiry date on the labelif 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.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 ELITechClinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I andELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitative invitro diagnostic determination of inorganic phosphorus in human serum andplasma. 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/dLAutomatic post-dilution: 96.72 mg/dL |
| Indication(s) for Use | ELITech Clinical Systems PHOSPHORUS is intended to measure inorganicphosphorus in human serum and plasma. (Inorganic) phosphorusmeasurements are used in the diagnosis and treatment of various disorders,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 runLevel 2.37 mg/dL CV=1.1%Level 4.80 mg/dL CV=1.5%Level 9.55 mg/dL CV=1.7% | Within runLevel 4.08 mg/dL CV=1.25%Level 6.34 mg/dL CV=0.77%Level 2.39 mg/dL CV=2.48%Level 3.48 mg/dL CV=1.61%Level 9.19 mg/dL CV=1.38% |
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Comparison to Predicate device
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| ELITech Clinical Systems DevicePHOSPHORUS | Predicate device(ABX PENTRA PHOSPHORUS CP) | |
|---|---|---|
| Total | Level 2.37 mg/dL CV=1.9%Level 4.80 mg/dL CV=1.7%Level 9.55 mg/dL CV=2.2% | TotalLevel 4.01 mg/dL CV=2.50%Level 6.35 mg/dL CV=1.82%Level 2.50 mg/dL CV=3.56%Level 11.44 mg/dL CV=1.38% |
| Method comparison | y=0.999 - 0.09 mg/dLr= 0.999range: 2.02 to 20.08 mg/dL | y=1.04x + 0.15 mg/dLr2= 0.998range: 0.30 to 24.08 mg/dL |
| Limitations | Hemoglobin: No significantinterference is observed up to 50mg/dL. Unconjugated bilirubin: Nosignificant interference is observedup to 15 mg/dLConjugated bilirubin: No significantinterference is observed up to 1.5mg/dL.Glucose: No significant interferenceis observed up to 500 mg/dL.Triglycerides: No significantinterference is observed up to 732mg/dL. | Hemoglobin: No significantinfluence is observed up to 125mg/dL.Triglycerides: No significantinfluence is observed up to 262.5mg/dL.Total bilirubin: No significantinfluence is observed up to 6 mg/dL.Direct bilirubin: No significantinfluence is observed up to 25mg/dL. |
| Calibration Frequency | 28 days | 34 days |
| On board stability | refrigerated area : 28 days | refrigerated area: 70 days |
| Calibrator | Recommended calibration material(not included):ELITech Clinical Systems Elical 2 | Recommended calibration material(not included):ABX Pentra Multical |
| Controls | Recommended quality controlmaterial (not included):ELITech Clinical Systems Elitrol I(Normal control)ELITech Clinical Systems Elitrol II(Pathologic control) | Recommended quality controlmaterial (not included):ABX Pentra N Control(Normal control)ABX Pentra P Control (Pathologiccontrol) |
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.
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SECTION 5 - 510(k) Summary ELITech Clinical Systems URIC ACID MONO SL reagent
| ELITech Clinical Systems Device.URIC ACID MONO SL | Predicate device :(ABX PENTRA URIC ACID CP) | ||||
|---|---|---|---|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | Intended use | Intended for use with ELITechClinical Systems ELICAL 2 andELITech Clinical Systems ELITROL Iand ELITROL II on Vital ScientificSelectra/Flexor analyzers for thequantitative in vitro diagnosticdetermination of uric acid in humanserum and plasma.It is not intended for use in Point ofCare settings. | For in vitro diagnostic use in thequantitative determination of uricacid in serum, plasma and urine. | |
| The assigned 510(k) number is: K100263 | Indication(s) for Use | Intended to measure uric acid inhuman serum and plasma. Uric acidmeasurements are used in thediagnosis and treatment ofnumerous renal and metabolicdisorders, including renal failure,gout, leukemia, psoriasis, starvationor other wasting conditions, and ofpatients receiving cytotoxic drugs. | Uric acid measurements are used in thediagnosis and treatment ofnumerous renal and metabolicdisorders, including renal failure,gout, leukemia, psoriasis, starvationor other wasting conditions, and ofpatients receiving cytotoxic drugs. | ||
| SubmitterAddressPhone numberFax number | SEPPIM S.A.S.Zone Industrielle, 61500 SEES, FRANCE+ 33 (0)2 33 81 21 00+ 33 (0)2 33 28 77 51 | Assay protocol | Enzymatic determination using achromgenic system in the presenceof peroxidase and uricase (Trindermethod). | Enzymatic determination using achromgenic system in the presenceof peroxidase and uricase (Trindermethod). | |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Composition | Reagent R:Phosphate buffer; pH 7.0 $100 mmol/L$ ;EHSPT $0.72 mmol/L$ ;Ferrocyanide $0.03 mmol/L$ ;Amino-4-antipyrine $0.37 mmol/L$ ;Uricase $\geq 150 U/L$ ;Peroxidase $\geq 12 000 U/L$ ;Sodium azide $< 0.1%$ ; | Reagent 1:Phosphate buffer, pH 7.0 $125 mmol/L$ ;EHSPT $1.38 mmol/L$ ;Ascorbate oxidase $\geq 1 100 U/L$ ;Bovine albumin $0.2 %$ ;Sodium azide $< 0.1%$ ;Reagent 2:4-Aminoantipyrine $1.8 mmol/L$ ;Uricase $\geq 700 U/L$ ;Peroxidase $\geq 7 500 U/L$Ferrocyanide $250 \mu mol/L$ ;Bovine albumin $0.2%$ :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 | SerumPlasma in lithium heparin | SerumPlasma in lithium heparinUrine | ||
| REAGENT :Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems URIC ACID MONO SLUric acid, "URIC ACID MONO SL"Class IUric acid test system (Sec.862.1775)KNK - Acid, Uric, Uricase (colorimetric) | Reagent storage | Store at 2-8 °C and protected fromlight. The reagent is stable until theexpiry date stated on the label. | Reagents, in unopened cassette, arestable up to expiry date on the labelif stored at 2-8 °C. | |
| Predicate device | ABX PENTRA Uric acid CP (K060205, K081276) | Expected values | Serum, plasmaWomen: 2.6 - 6.0 mg/dLMen: 3.5 - 7.2 mg/dL | Serum, plasmaWomen: 2.6 - 6.0 mg/dLMen: 3.5 - 7.2 mg/dL | |
| Device description | The device for this submission is available as kit only. It consists of 1 reagent R.Reagent R consists of Phosphate buffer (pH 7.0), N-Ethyl-N-(2-Hydroxy-3-Sulfopropyl) m-Toluidine (EHSPT), Ferrocyanide, Amino-4-antipyrine (4-AAP),Uricase (microorganisms), Peroxidase (horseradich) and sodium azide. | ||||
| Intended Use | ELITech Clinical Systems URIC ACID MONO SL is intended for use withELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL Iand ELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitativein vitro diagnostic determination of uric acid in human serum and plasma.It is not intended for use in Point of Care settings. | ||||
| Indication(s) for Use | ELITech Clinical Systems URIC ACID MONO SL is intended to measure uricacid in human serum and plasma. Uric acid measurements are used in thediagnosis and treatment of numerous renal and metabolic disorders, includingrenal failure, gout, leukemia, psoriasis, starvation or other wasting conditions,and of patients receiving cytotoxic drugs. |
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Comparison to Predicate device
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| ELITech Clinical Systems DeviceURIC ACID MONO SL | Predicate device(ABX PENTRA URIC ACID CP) | |
|---|---|---|
| Instrument | SELECTRA JUNIOR | ABX PENTRA 400 |
| Measuring range | 1.5 to 25.0 mg/dLExtended measuring range : 25 to 78 mg/dL | 0.18 to 25.00 mg/dLAutomatic post-dilution: 75.00 mg/dL |
| Limit of detection (LoD) | 0.02 mg/dL | 0.19 mg/dL |
| Limit of quantification (LoQ) | 0.50 mg/dL | |
| Precision | Within runLevel 2.49 mg/dL CV=0.8%Level 5.19 mg/dL CV=1.3%Level 7.63 mg/dL CV=1.1%TotalLevel 2.49 mg/dL CV=2.6%Level 5.19 mg/dL CV=2.0%Level 7.63 mg/dL CV=2.1% | Within runLevel 4.62 mg/dL CV=0.45%Level 11.63 mg/dLCV=0.34%Level 2.53 mg/dL CV=1.24%Level 4.58 mg/dL CV=0.91%Level 7.19 mg/dL CV=1.02%TotalLevel 4.64 mg/dL CV=2.81%Level 11.73 mg/dLCV=1.39%Level 4.67 mg/dL CV=2.64%Level 6.74 mg/dL CV=2.51% |
| Method comparison | y=1.015 x + 0.03 mg/dLr= 0.999range: 1.49 to 24.40 mg/dL | y=0.95 x + 0.09 mg/dLr2= 0.996range: 0.18 to 23.59 mg/dL |
| Limitations | Hemoglobin: No significantinterference up to 50 mg/dL.Unconjugated bilirubin: Nosignificant interference up to 30mg/dLConjugated bilirubin: Nosignificant interference up to 14.8mg/dL.Glucose: No significant interferenceup to 500 mg/dL.Ascorbic acid: Significantinterference on samples containingascorbic acid.Triglycerides:. No significantinterference up to 1070 mg/dL.Methyldopa: No significantinterference up to 1 mg/dL.Calcium dobesilate: Induces falselylow results on individuals takingcalcium dobesilate. | Hemoglobin: No significantinfluence is observed up to 500mg/dL.Triglycerides: No significantinfluence is observed up to 612.5mg/dL.Total bilirubin: No significantinfluence is observed up to 36mg/dL.Direct bilirubin: No significantinfluence is observed up to 30mg/dL. |
| Calibration Frequency | 28 days | 15 days |
| ELITech Clinical Systems DeviceURIC ACID MONO SL | Predicate device(ABX PENTRA URIC ACID CP) | |
| On board stability | refrigerated area : 28 days | refrigerated area: 41 days |
| Calibrator | Recommended calibration material(not included):ELITech Clinical Systems Elical 2 | Recommended calibration material(not included):ABX Pentra Multical |
| Controls | Recommended quality controlmaterial (not included):ELITech Clinical Systems Elitrol I(Normal control)ELITech Clinical Systems Elitrol II(Pathologic control) | Recommended quality controlmaterial (not included):ABX Pentra N Control(Normal control)ABX Pentra P Control (Pathologiccontrol) |
.
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Conclusion
The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
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SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELITROL I and ELITROL II
| Introduction | According to the requirements of 21 CFR 807.92, the followinginformation provides sufficient detail to understand the basis for adetermination of substantial equivalence. | |
|---|---|---|
| The assigned 510(k) number is: K100263 | ||
| SubmitterAddressPhone numberFax number | SEPPIM S.A.S.Zone Industrielle, 61500 SEES, FRANCE+ 33 (0)2 33 81 21 00+ 33 (0)2 33 28 77 51 | |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | |
| Date of Preparation | Friday, January 22nd 2010 | |
| Device names | ||
| CONTROLS:Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems ELITROL I and ELITROL IIMulti-analyte controls - all kinds, "ELITROL I"- "ELITROL II"Class IQuality control material (assayed and unassayed). (21 CFR 862.1660)JJX- Multi-analyte controls - all kinds | |
| Predicate device | Roche Diagnostics Precinorm U (K041227)Roche Diagnostics Precipath U (K041227) | |
| Device description | ELITech Clinical Systems ELITROL I and ELITROL II are two level quality controlproducts consisting of lyophilized human serum containing constituents at desiredlevels.Elitrol I and Elitrol II are prepared exclusively from the blood of donors testedindividually and found to be negative for HbsAg and to antibodies to HCV and HIVaccording to FDA-approved methods or methods in compliance with the EuropeanDirective 98/79/EC, Annex II, List A. | |
| Intended Use | ELITech Clinical Systems ELITROL I is a multi-parametric control serum for invitro diagnostic use in accuracy control of quantitative ELITech Clinical Systemsmethods on the Vital Scientific Selectra Junior Analyzer and the Vital ScientificFlexor Junior Analyzer. |
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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 Analyzer.
Comparison to Predicate device
| ELITech Clinical Systems DeviceELITROL I / ELITROL II | Predicate DeviceRoche Precinorm U / Precipath U | ||
|---|---|---|---|
| Intended use | ELITech Clinical Systems ELITROL I is amulti-parametric control serum for in vitrodiagnostic use in accuracy control ofquantitative ELITech Clinical Systemsmethods on the Vital Scientific SelectraJunior Analyzer and the Vital ScientificFlexor Junior Analyzer.ELITech Clinical Systems ELITROL II isa multi-parametric control serum for in vitro diagnostic use in accuracy controlof quantitative ELITech Clinical Systemsmethods on the Vital Scientific SelectraJunior Analyzer and the Vital ScientificFlexor Junior Analyzer. | For in vitro diagnostic use in qualitycontrol by monitoring accuracy andprecision for the quantitative methodsas specified in the value sheet. | |
| Format | Lyophilized human sera with constituentsadded as required to obtain desiredcomponents levels | Lyophilized human sera withconstituents added as required toobtain desired components levels | |
| Levels | Two levels | Two levels | |
| Handling | Carefully open the vial, avoiding the lossof lyophilate, and pipette in exactly 5 mLof distilled/deionized water. Carefullyclose the vial and dissolve the contentscompletely by occasional gentle swirlingwithin 30 minutes avoiding the formationof foam. | Carefully open the bottle, avoiding theloss of lyophilate, and pipette in exactly5 mL of distilled/deionized water.Carefully close the bottle and dissolvethe contents completely by occasionalgentle swirling within 30 minutes.Avoid the formation of foam. | |
| Stability | Lyophilized:To store at 2-8°C and protected fromlight until the expiry dateAfter reconstitution, the stabilities are :- 12 hours between 15-25 °C.- 5 days between 2-8 °C.- 4 weeks between -25 and -15 °C (whenfrozen once) | Lyophilized:Stable at 2-8°C up to expiration date.After reconstitution, the stabilities* are :- 12 hours at 15-25 °C.- 5 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once)*Exception for bilirubin total & direct asnoted in package insert | |
| Conclusion | The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not |
ess 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
Image /page/15/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
ELITech Group Epoch Biosciences c/o Debra Hutson 21720 23rd Dr., SE, Suite 150 Bothell. WA 98021
Re: K100263
Trade/Device Name: ELITech Clinical Systems Urea UV SL Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDQ, KNK, CEO, JIX, JJY Dated: 30 March 2011 MAY -6 2011 Received: 04 April 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
Courtney C. 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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Image /page/17/Picture/0 description: The image is a simple black and white image with a few small, dark spots scattered across the white background. The spots are irregularly shaped and vary slightly in size. The overall impression is one of sparseness and simplicity, with the dark spots providing a minimal contrast against the bright white backdrop.
510(k) Number (if known): K100263
Device Name:
Indications for 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
RA
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100263
Page 1 of J
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510(k) Number (if known): K100263
Device Name:
Indications for Use:
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.
X Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100263
Page 2 of J
ﺮ ﺍ
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510(k) Number (if known): K100263
Device Name:
Indications for Use:
!
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.
x 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) K100263
Page of J
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510(k) Number (if known): K100263
ELITech Clinical Systems ELICAL 2__________________________ Device Name:
Indications for Use:
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
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) K100263
Page + of 5
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510(k) Number (if known): K100263_________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
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.
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) K/00263
Page of of J
§ 862.1580 Phosphorus (inorganic) test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.