(366 days)
ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.
The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: MOPS buffer (pH 7.50), EHSPT (N-Ethyl-N-2(-Hydroxy-3-Sulfopropyl)- m -Toluidine), Creatinase (microoganism), Sarcosine oxidase (microoganism), Ascorbate oxidase (vegetal). Reagent R2 contains: MOPS buffer (pH 7.50), Amino-4-antipyrine (4-AAP), Creatininase (bacterial), Peroxidase (horseradish), and Sodium azide.
The provided text describes the ELITech Clinical Systems CREATININE PAP SL device, its calibrator (ELICAL 2), and controls (ELITROL I and ELITROL II). It details their intended use, composition, and performance characteristics, comparing them to predicate devices. The document essentially serves as a summary for a 510(k) premarket notification to the FDA, demonstrating substantial equivalence.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance data for the ELITech Clinical Systems CREATININE PAP SL and compares it directly to a predicate device (Roche Diagnostics Creatinine plus ver.2). The implication is that performance comparable to or better than the predicate device satisfies the acceptance criteria for substantial equivalence.
Here's a table summarizing the performance metrics and their comparison to the predicate device:
| Performance Characteristic | ELITech Clinical Systems CREATININE PAP SL (Reported Performance) | Predicate Device (Roche Diagnostics Creatinine plus ver.2) | Implied Acceptance Criteria (Demonstrates Substantial Equivalence) |
|---|---|---|---|
| Measuring Range | 0.28 - 22.30 mg/dL | 0.06 - 30.5 mg/dL | Range should cover clinically relevant levels and be comparable to predicate. (ELITech's range is narrower on both ends than the predicate). |
| Limit of Detection (LoD) | 0.006 mg/dL | Serum/plasma: 0.06 mg/dL | LoD should be sufficiently low for clinical utility and comparable to predicate. (ELITech's LoD is lower/better than the predicate for serum/plasma). |
| Limit of Quantification (LoQ) | 0.28 mg/dL | Not explicitly stated for LoQ, but LoD provides a lower bound. | LoQ should be clinically acceptable. (Compared to predicate's LoD, ELITech's LoQ is higher, but this is a different metric). |
| Precision (Within Run) | Level 0.59 mg/dL: CV=1.3%Level 1.62 mg/dL: CV=0.8%Level 6.93 mg/dL: CV=1.4% | Level 0.97 mg/dL: CV=2.29%Level 3.95 mg/dL: CV=1.16%Level 0.77 mg/dL: CV=2.86%Level 12.7 mg/dL: CV=1.26% | Coefficient of Variation (CV) should indicate acceptable reproducibility and be comparable to predicate. (ELITech's within-run CVs generally appear better at comparable levels). |
| Precision (Total) | Level 0.59 mg/dL: CV=3.2%Level 1.62 mg/dL: CV=1.6%Level 6.93 mg/dL: CV=2.8% | Level 0.97 mg/dL: CV=2.35%Level 3.95 mg/dL: CV=0.91%Level 0.75 mg/dL: CV=1.87%Level 13.2 mg/dL: CV=0.60% | CV should indicate acceptable reproducibility over time and be comparable to predicate. (ELITech's total CVs are mixed; some better, some worse than predicate at comparable levels). |
| Method Comparison (Regression) | y = 1.045x - 0.01 mg/dLr = 0.999Range: 0.30 to 20.30 mg/dL | y = 1.006x - 0.013 mg/dLr = 0.9998Range: 0.52 to 18.9 mg/dL | Regression analysis (slope, intercept, correlation coefficient) should demonstrate strong agreement with the predicate method. (Both devices show excellent correlation (r close to 1) and similar regression equations). |
| Interferences (Limitations) | Hemoglobin: No interference up to 500 mg/dL.Triglycerides: No interference up to 3198 mg/dL.Unconjugated bilirubin: No interference up to 30.0 mg/dL.Conjugated bilirubin: No interference up to 14.8 mg/dL.Uric acid: No interference up to 24 mg/dL.Glucose: No interference up to 550 mg/dL.Ascorbic acid: No interference up to 20 mg/dL.Methyl-dopa, L-dopa, Calcium dobesilate: Falsely low results at therapeutic conc.Creatine: Positive bias from 5 mg/dL. | Hemoglobin: No interference up to 800 mg/dL.Lipemia (Intralipid): No influence up to L index of 1000.Icterus: No influence up to I Index of 20 (20 mg/dL bilirubin).Ascorbic acid: < 300 mg/L (30 mg/dL) does not interfere.Drugs: No interference with common drug panels.Exceptions: Levodopa and calcium dobesilate cause artificially low creatinine levels.Other: Monoclonal gammopathy can lead to incorrect results.Creatine: No significant interference up to 20 mg/dL. | Interference profile should be understood and comparable or better, with identified limitations. (ELITech shows similar interference patterns for some substances, but different thresholds for others, and similar specific drug interferences. Creatine interference is noted at a lower level for ELITech). |
| Calibration Frequency | 14 days | Each lot and as required | Clinically acceptable calibration stability. (ELITech's 14-day calibration is a defined period). |
| On-board Stability | 28 days (refrigerated area) | 4 weeks (refrigerated area) | Stability should be sufficient for practical lab use. (Comparable at 28 days vs 4 weeks). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the sample sizes used for each performance study (e.g., precision, method comparison). For method comparison, it mentions a range of 0.30 to 20.30 mg/dL, implying multiple samples across this range were tested, but no specific number of samples (N) is given.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective. It only states the submitter is SEPPIM S.A.S. from France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts/Qualifications: Not applicable for this type of in vitro diagnostic device (IVD). For IVDs like creatinine assays, "ground truth" is typically established by reference methods or validated comparative methods, not by human expert interpretation of images or other subjective data. The predicate device itself (Roche Diagnostics Creatinine plus ver.2) serves as the primary "ground truth" for method comparison, which is a common approach for demonstrating substantial equivalence for clinical chemistry assays.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. As described above, this is an IVD assay where performance is determined by analytical measurements against established methods, not by expert adjudication of subjective results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No. MRMC studies are typically used for medical imaging devices where human readers interpret results. This is a clinical chemistry assay, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, implicitly. The performance data presented (measuring range, LoD, LoQ, precision, method comparison, limitations) are for the device (reagent and instrument) operating in a standalone analytical capacity, without direct human cognitive interpretation or intervention required for each result once the assay is set up. The performance metrics reflect the algorithm's (assay's) ability to quantify creatinine directly.
7. The Type of Ground Truth Used:
- Ground Truth Type:
- Method Comparison: The predicate device itself (Roche Diagnostics Creatinine plus ver.2) serves as the "ground truth" or reference for comparison in the method comparison study. The agreement (regression analysis) between the new device and the predicate is the primary evidence of performance.
- Analytical Performance: For parameters like LoD, LoQ, and precision, the "ground truth" is derived from established analytical methods and statistical calculations following laboratory guidelines for assay validation. While not explicitly stated, this would typically involve using known concentration samples or highly characterized materials.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This document is for an IVD reagent system, not a machine learning or AI model that requires a distinct "training set" for development in the typical sense. The assay chemistry and instrument parameters are developed through conventional analytical chemistry and engineering processes.
9. How the Ground Truth for the Training Set was Established:
- Training Set Ground Truth: Not applicable for the reasons stated above. The development of the assay chemistry involves extensive R&D and optimization, but not a "training set" with ground truth in the context of AI/ML.
In Conclusion:
The ELITech Clinical Systems CREATININE PAP SL's acceptance criteria are implicitly defined by the analytical performance of its legally marketed predicate device. The study demonstrates that the new device exhibits comparable analytical performance across various metrics (precision, method comparison, detection limits, and interference profiles), thereby meeting the requirements for substantial equivalence. The studies conducted are typical analytical validation studies for IVD assays, focusing on the device's standalone performance in quantifying creatinine.
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/S2
SECTION 5 - 510(k) Summary
ELITech Clinical Systems CREATININE PAP SL
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination of sub-stantial equivalence. | ELITech Clinical Systems DeviceCREATININE PAP SL | Predicate device(Roche Diagnostics Creatinine plusver.2) | |
|---|---|---|---|---|
| The assigned 510(k) number is: K103376 | Intended use | Intended for the quantitative in vitrodiagnostic determination of creatininein human serum or plasma on VitalScientific Selectra/Flexor analyzers.It is not intended for use in Point ofCare settings. | For in vitro diagnostic use in the quan-titative determination of creatinine inserum, plasma and urine on the cobasc111 system. | |
| 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 for Use | Creatinine measurements are used inthe diagnosis and treatment of renaldiseases, and in monitoring renaldialysis. | Creatinine measurements are used inthe diagnosis and treatment renaldiseases, in monitoring renal dialysisand as a calculation basis for measur-ing other urine analytes. |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Assay protocol | Enzymatic colorimetric test | Enzymatic colorimetric test |
| Date of Preparation | November 8th, 2010 | Composition | Reagent R1:MOPS buffer (pH 7.50)EHSPT$0.4 ormal{mmol/L};$Creatinase$\ge 10 000 ormal{U/L};$Sarcosine oxidase$\ge 3 250 ormal{U/L};$Ascorbate oxidase$\ge 1 000 ormal{U/L};$Reagent R2: | Reagent R1:TAPS buffer$30 ormal{mmol/L};$Creatinase$\ge 332 \mu ormal{kat/L};$Sarcosine oxidase$\ge 132 \mu ormal{kat/L};$Ascorbate oxidase$\ge 33 \mu ormal{kat/L};$HITB$1.2 ormal{g/L};$DetergentsPreservative |
| Device names | MOPS buffer (pH 7.50)4-Aminoantipyrine$2.95 ormal{mmol/L};$Creatininase$\ge 150 000 ormal{U/L};$Peroxidase$\ge 4 000 ormal{U/L};$Sodium azide$< 0.1 %;$ | Reagent R2:TAPS buffer$50 ormal{mmol/L};$Creatininase$\ge 498 \mu ormal{kat/L};$4-Aminophenazone$0.5 ormal{g/L};$Peroxidase$\ge 16.6 \mu ormal{kat/L};$Potassium hexacyanoferrate(II)$60 ormal{mg/L};$DetergentsPreservative | ||
| REAGENTTrade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems CREATININE PAP SLCreatinine, "CREATININE PAP SL"Class IICreatinine test system (Sec.862.1225)JFY- Enzymatic method, Creatinine | Appearance of re-agents | Liquid form, ready to use | Same |
| Predicate device | Roche Diagnostics Creatinine plus ver.2 (K024098) | Sample type | Serum .Plasma | SerumPlasmaUrine |
| Device description | The device for this submission is available as kit only. It consists of 2reagents, "R1" and "R2".Reagent R1 contains: MOPS buffer (pH 7.50), EHSPT (N-Ethyl-N-2(-Hydroxy-3-Sulfopropyl)- m -Toluidine), Creatinase (microoganism), Sarcosineoxidase (microoganism), Ascorbate oxidase (vegetal).Reagent R2 contains: MOPS buffer (pH 7.50), Amino-4-antipyrine (4-AAP),Creatininase (bacterial), Peroxidase (horseradish), and Sodium azide. | Reagent storage | Store at 2-8 °C and protect from light.The reagent is stable until the expirydate stated on the label. | Stored at 2-8 °C.Reagents are stable until the expirydate stated on the label. |
| Intended Use | ELITech Clinical Systems CREATININE PAP SL is intended for the quantita-tive in vitro diagnostic determination of CREATININE in human serum andplasma on Vital Scientific Selectra/Flexor analyzers. It is not intended foruse in Point of Care settings. | Expected values | Serum/plasma:Adults :Females 0.55 - 1.02 mg/dLMales 0.72 - 1.18 mg/dL | Serum/plasma:Adults :Females 0.51 - 0.95 mg/dLMales 0.67 - 1.17 mg/dLChildren:Neonates(premat.) 0.33-0.98 mg/dLNeonates(full term) 0.31-0.88 mg/dL2-12 m0.16-0.39 mg/dL1-< 3 y0.18-0.35 mg/dL3-< 5 y0.26-0.42 mg/dL5-< 7 y0.29-0.47 mg/dL7-< 9 y0.34-0.53 mg/dL9-< 11 y0.33-0.64 mg/dL |
| Indication for use | ELITech Clinical Systems CREATININE PAP SL is intended to measurecreatinine in human serum and plasma. Creatinine measurements are usedin the diagnosis and treatment of renal diseases and in monitoring renal di-alysis. |
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Comparison to Predicate device
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| ELITech Clinical Systems DeviceCREATININE PAP SL | Predicate device(Roche Diagnostics Creatinine plusver.2) | |
|---|---|---|
| 13-< 15 y0.46-0.77 mg/dL | ||
| Instrument | Vital Scientific SELECTRA JUNIOR | Cobas c111 |
| Measuring range | 0.28 - 22.30 mg/dL | 0.06 - 30.5 mg/dL |
| Limit of detection(LoD) | 0.006 mg/dL | Serum/plasma: 0.06 mg/dL |
| Limit of quantification(LoQ) | 0.28 mg/dL | |
| Precision | Within run | Serum/plasma:Within run |
| Level 0.59 mg/dL CV=1.3% | Level 0.97 mg/dL CV=2.29% | |
| Level 1.62 mg/dL CV=0.8% | Level 3.95 mg/dL CV=1.16% | |
| Level 6.93 mg/dL CV=1.4% | Level 0.77 mg/dL CV=2.86% | |
| Level 12.7 mg/dL CV=1.26% | ||
| Total | Total | |
| Level 0.59 mg/dL CV=3.2% | Level 0.97 mg/dL CV=2.35% | |
| Level 1.62 mg/dL CV=1.6% | Level 3.95 mg/dL CV=0.91% | |
| Level 6.93 mg/dL CV=2.8% | Level 0.75 mg/dL CV=1.87% | |
| Level 13.2 mg/dL CV=0.60% | ||
| Method comparison | $y=1.045x - 0.01 mg/dL$ | Serum/plasma: |
| r= 0.999 | $y=1.006x - 1.11899 µmol/L (0.013 mg/dL)$ | |
| range: 0.30 to 20.30 mg/dL | r= 0.9998 | |
| range: 45.9 to 1674 µmol/L (0.52 to 18.9 mg/dL) | ||
| Limitations | Hemoglobin: No significant interfer-ence up to 500 mg/dL. | Hemoglobin: No significant interfer-ence up to an H Index of 800 (approximate 800 mg/dL). |
| Triglycerides: No significant interfer-ence up to 3198 mg/dL . | Lipemia (Intralipid): No significantinfluence up to an L index of 1000.There is poor correlation between theL index (corresponds to turbidity) andtriglycerides concentration. | |
| Unconjugated bilirubin: No signifi-cant interference up to 30.0 mg/dL. | Icterus: No significant influence up toI Index of 20 (approximate conjugated and unconjugated bilirubin concentration of 20 mg/dL (342 µmol/L)). | |
| Conjugated bilirubin: No significantinterference up 14.8 mg/dL. | Ascorbic acid: < 300 mg/L does not interfere. | |
| Uric acid: No significant interferenceup to 24 mg/dL. | Drugs: No interference was found at therapeutic concentrations using common drug panels. | |
| Glucose: No significant interferenceup to 550 mg/dL. | Exceptions: Levodopa and calcium dobesilate cause artificially low creatinine levels at the tested drug level | |
| Ascorbic acid: No significant interfer-ence up to 20 mg/dL. | Other: In very rare cases monoclonal gammopathy can lead to incorrect results. | |
| Methyl-dopa: Induce falsely low results at therapeutic concentrations. | No significant interference up to a creatine level of 20 mg/dL. | |
| L-dopa: Induce falsely low results at therapeutic concentrations. | ||
| Calcium dobesilate: Induce falselylow results at therapeutic concentrations. | ||
| Creatine: Positive bias from 5 mg/dL. | ||
| Calibration Frequency | 14 days | Each lot and as required following quality control procedures. |
| ELITech Clinical Systems DeviceCREATININE PAP SL | Predicate device(Roche Diagnostics Creatinine plusver.2) | |
| On board stability | refrigerated area : 28 days | refrigerated area: 4 weeks |
| Calibrator | Recommended calibration material(not included):ELITech Clinical Systems ELICAL 2 | Recommended calibration material(not included):Roche Calibrator f.a.s. |
| Controls | Recommended quality control material(not included):ELITech Clinical Systems ELITROL I(Normal control)ELITech Clinical Systems ELITROL II(Pathologic control) | Recommended quality control material(not included):Roche Precinorm URoche Precipath U |
'
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Device names
| CALIBRATOR : | |
|---|---|
| Trade/proprietary Name: | ELITech Clinical Systems ELICAL 2 |
| Common or Usual Name: | Calibrator, multi-analyte mixture, "ELICAL 2" |
| Device Class | Class II |
| Classification name | Calibrator (21 CFR 862.1150) |
| Product code | JIX- Calibrator, multi-analyte mixture |
·
| Predicate device | Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)(K033501) | |
|---|---|---|
| Device description | ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based onhuman serum containing constituents to ensure optimal calibration.ELICAL 2 is prepared exclusively from the blood of donors tested individuallyand found to be negative for HbsAg and to antibodies to HCV and HIV ac-cording to FDA-approved methods or methods in compliance with the Euro-pean Directive 98/79/EC, Annex II, List A. | |
| Intended Use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for invitro diagnostic use in the calibration of quantitative ELITech Clinical Sys-tems methods on Vital Scientific Selectra Junior Analyzer and Vital ScientificFlexor Junior Analyzer. | |
| ELITech Clinical Systems Device(ELICAL 2) | Predicate device(Roche Calibrator f.a.s.) | |
| Intended use | ELITech Clinical Systems ELICAL2 is a multi-parametric calibratorfor in vitro diagnostic use in thecalibration of quantitative ELITechClinical Systems methods on VitalScientific Selectra Junior Analyzerand Vital Scientific Flexor JuniorAnalyzer. | For in vitro diagnostic use in thecalibration of quantitative Rochemethods on Roche clinical chemis-try analysers as specified in thevalue sheets. |
| Format | Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels | Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding theloss of lyophilate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely 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. |
| Traceability | Traceability information is given inthe value sheet included in the box. | Traceability of the target value isgiven in the respective instructionfor use of the system reagents. |
| Stability | Lyophilized:To store at 2-8°C and protectedfrom light until the expiry dateAfter 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) | Lyophilized:Stable at 2-8°C up to expirationdate.After reconstitution, the stabilities*are :- 8 hours at 15-25 °C.- 2 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once)*Exception for bilirubin total & directas noted in package insert |
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Comparison to Predicate device
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،
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 CFR862.1660) |
|---|---|
| JJY- Multi-analyte controls - all kinds | |
| Predicate device | Roche Diagnostics Precinorm U (K041227)Roche Diagnostics Precipath U (K041227) |
| Device description | ELITech Clinical Systems ELITROL I and ELITROL II are two level qualitycontrol products consisting of lyophilized human serum containing constituentsat desired levels.Elitrol I and Elitrol II are prepared exclusively from the blood of donors testedindividually and found to be negative for HbsAg and to antibodies to HCV andHIV according to FDA-approved methods or methods in compliance with theEuropean Directive 98/79/EC, Annex II, List A. |
| Intended Use | ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametriccontrol sera for in vitro diagnostic use in accuracy control of quantitativeELITech Clinical Systems methods on Vital Scientific Selectra Junior Analyzerand Vital Scientific Flexor Junior Analyzer. |
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Comparison to Predicate device
| ELITech Clinical Systems Device | Predicate Device | |
|---|---|---|
| ELITROL I / ELITROL II | Roche Precinorm U / Precipath U | |
| Intended use | ELITech Clinical Systems ELITROLI and ELITROL II are multi-parametric control sera for in vitrodiagnostic use in accuracy controlof quantitative ELITech ClinicalSystems methods on Vital ScientificSelectra Junior Analyzer and VitalScientific Flexor Junior Analyzer. | For in vitro diagnostic use in qualitycontrol by monitoring accuracy andprecision for the quantitative meth-ods as specified in the value sheet |
| Format | Lyophilized human sera with con-stituents added as required to ob-tain desired components levels | Lyophilized human sera with con-stituents added as required to ob-tain desired components levels |
| Levels | Two levels | Two levels |
| Handling | Carefully open the vial, avoiding theloss of lyophilate, and pipette inexactly 5 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam. | Carefully open the bottle, avoidingthe loss of lyophilate, and pipette inexactly 5 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation offoam. |
| Stability | Lyophilized:To store at 2-8°C and protectedfrom light until the expiry dateAfter reconstitution, the stabilitiesare :- 12 hours between 15-25 °C.- 5 days between 2-8 °C.- 4 weeks between -25 and -15 °C(when frozen once) | Lyophilized:Stable at 2-8°C up to expirationdate.After reconstitution, the stabilities*are :- 12 hours at 15-25 °C.- 5 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once)*Exception for bilirubin total & directas noted in package insert |
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Seppim S.A.S. C/O Debra Hutson Elitechgroup Epoch Biosciences 21720 23td Dr, SE Suite 150 Bothell, Washington 98021
NOV 1 8 2011
Re: K103376
Trade Name: Elitech Clinical Systems Creatinne PAP SL Regulation Number: 21 CFR §862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Codes: JFY, JJY, JIX Dated: October 26, 2011 Received: October 27, 2011
Dear Ms. Hutson
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR 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/Medical Devices/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/ResourcesforYou/Industry/default.htm
Sincerely yours,
N.
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): K103376
Device Name:
Indications for Use:
ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103376
Page 1 of 3
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Indications for Use Form
510(k) Number (if known): _k103376 __________________________________________________________________________________________________________________________________________
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 Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzers.
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)
CARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_k103376
{11}------------------------------------------------
Indications for Use Form
510(k) Number (if known): _k103376 ___________________________________________________________________________________________________________________________________________
ELITech Clinical Systems ELITROL I Device Name: ELITech Clinical Systems ELITROL 11
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 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)
C. A. Z.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103376
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.