(200 days)
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems BILIRUBIN TOTAL 4+1: The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains sulfanilic acid, Hydrochloric acid and cetrimide. Reagent R2 contains sodium nitrite.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1: The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains sulfanilic acid and Hydrochloric acid. Reagent R2 contains sodium nitrite.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the ELITech Clinical Systems Bilirubin devices.
Important Note: The provided text is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, independent study seeking to establish the device's absolute performance against a
predefined, absolute acceptance criteria. The "acceptance criteria" in this context refer to the performance benchmarks the new device needs to meet to be considered "substantially equivalent" to an already cleared device, typically by showing similar or better performance in key metrics. The study described is a comparison study against the predicate, not a study to prove meeting absolute acceptance criteria in the same way a de novo or PMA device would.
Acceptance Criteria and Device Performance for ELITech Clinical Systems BILIRUBIN TOTAL 4+1
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | ELITech Clinical Systems BILIRUBIN TOTAL 4+1 (New Device) Performance | Predicate Device (ABX PENTRA BILIRUBIN, TOTAL CP) Performance | Substantial Equivalence Criteria (Implied) |
|---|---|---|---|
| Measuring Range | 0.28 to 20.22 mg/dL | 0.2 to 26.3 mg/dL | Comparable measuring range (within clinically acceptable limits) |
| Limit of Detection | 0.06 mg/dL | 0.09 mg/dL | Comparable or better LoD |
| Limit of Quant. | 0.17 mg/dL | 0.14 mg/dL | Comparable or better LoQ |
| Precision (Within Run) | Level 1.04 mg/dL: CV=2.7% | Level 0.97 mg/dL: CV=2.14% | Comparable or better precision |
| Level 3.67 mg/dL: CV=0.8% | Level 5.13 mg/dL: CV=0.99% | ||
| Level 14.90 mg/dL: CV=0.5% | Level 0.61 mg/dL: CV=3.09% | ||
| Level 0.85 mg/dL: CV=2.23% | |||
| Level 2.20 mg/dL: CV=1.33% | |||
| Precision (Total) | Level 1.04 mg/dL: CV=4.0% | Level 1.0 mg/dL: CV=4.04% | Comparable or better precision |
| Level 3.67 mg/dL: CV=2.0% | Level 5.5 mg/dL: CV=1.70% | ||
| Level 14.90 mg/dL: CV=1.8% | Level 0.8 mg/dL: CV=5.97% | ||
| Level 2.9 mg/dL: CV=2.78% | |||
| Level 9.1 mg/dL: CV=2.20% | |||
| Method Comparison (Correlation) | y=0.924x + 0.02 mg/dL, r² = 0.998 | y=1.03x - 0.14 mg/dL, r² = 0.9965 | High correlation (r² close to 1) indicating agreement with predicate. Equation slope and intercept should demonstrate clinical equivalence. |
| (Range) | 0.25 to 22.00 mg/dL | 0.3 to 25.8 mg/dL | Consistent measurement range for method comparison. |
| Limitations (Interference) | Triglycerides: No significant interference up to 2779 mg/dL | Triglycerides: No significant influence up to 612.5 mg/dL | Comparable or better interference profile, especially for common interferents. |
| Hemoglobin: No significant interference up to 500 mg/dL | Hemoglobin: No significant influence up to 500 mg/dL | ||
| Acetaminophen: No significant interference up to 30 mg/dL | (Not reported for predicate in summary) | ||
| Ascorbic acid: Interference > 2.0 mg/dL | (Not reported for predicate in summary) | ||
| Acetylsalicylic acid: No significant interference up to 200 mg/dL | (Not reported for predicate in summary) | ||
| Calibration Freq. | 28 days | 10 days | Device performance maintained over specified calibration period. (Better is generally preferred) |
| On-board Stability | 28 days (refrigerated area) | 25 days (refrigerated area) | Device performance maintained over specified on-board stability. (Better is generally preferred) |
Study Details for ELITech Clinical Systems BILIRUBIN TOTAL 4+1
The information provided is a 510(k) Summary, which typically presents a comparison between a new device and a legally marketed predicate device to establish "substantial equivalence." It doesn't detail a standalone study with pre-defined, absolute acceptance criteria in the same way a full clinical trial would. Instead, the "study" is a series of in-vitro analytical performance tests comparing the new device against the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the total number of patient samples used for the method comparison or interference studies. For precision, specific levels are tested, but the number of replicates/runs is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's an in-vitro diagnostic, the samples would likely be human serum and plasma, possibly from a clinical lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is an in-vitro diagnostic device for quantitative measurement. The "ground truth" for the test set is established by the measurements obtained from the predicate device (ABX PENTRA BILIRUBIN, TOTAL CP) and potentially reference methods or characterized materials for analytical performance studies (e.g., linearity, LoD, LoQ).
- No human experts (e.g., radiologists, pathologists) are explicitly mentioned as establishing ground truth in this context, as the output is a quantitative biochemical measurement, not an interpretive one.
4. Adjudication Method for the Test Set
- Not applicable as this is an analytical performance study comparing quantitative measurements, not an interpretive study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC study was not done. This type of study is relevant for interpretive tasks where human readers (e.g., radiologists) provide diagnoses, and AI assistance is evaluated. This device is an automated in-vitro diagnostic assay.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
- Yes, the performance metrics reported (Measuring range, LoD, LoQ, Precision, Method Comparison, Limitations) are for the standalone algorithm/device as an automated assay. There is no human intervention in the measurement process other than preparing samples and operating the analyzer.
7. Type of Ground Truth Used
- The "ground truth" for comparative purposes against the predicate device is implied to be the measurements obtained from the predicate device itself for method comparison studies. For other analytical performance elements (LoD, LoQ, precision), validated reference materials or spiked samples are typically used.
8. Sample Size for the Training Set
- The document does not specify a "training set" size. This is an analytical device where performance is characterized rather than a machine learning algorithm that is "trained" on a dataset in the conventional sense. The device's components (reagents, analyzer settings) are developed and optimized, but the concept of a "training set" as used in AI/ML is not directly applicable here.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there's no conventional "training set" for a machine learning algorithm. The development and optimization of the reagent formulation and instrument parameters would be based on established chemical and analytical principles and potentially internal validation studies with characterized samples.
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・
OCT -
7 2011
SECTION 5 - 510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | |
|---|---|---|
| The assigned 510(k) number is: K110780 | ||
| 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)Debra K. Hutson (email: d.hutson@elitechgroup.com) | |
| Date of Preparation | Sept 9, 2011 | |
| Device names | ||
| REAGENT:Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems BILIRUBIN TOTAL 4+1Bilirubin total, "BILIRUBIN TOTAL 4+1"Class IIBilirubin (Total or Direct) test System (Sec.862.1110)CIG - Diazo Colorimetry, Bilirubin | |
| Predicate device | ABX PENTRA BILIRUBIN, TOTAL CP (K060325) | |
| Device description | The device for this submission is available as kit only. It consists of 2reagents, "R1" and "R2".Reagent R1 contains sulfanilic acid, Hydrochloric acid and cetrimide.Reagent R2 contains sodium nitrite. | |
| Intended Use | ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for thequantitative in vitro diagnostic determination of total bilirubin in human serumand plasma on ELITech Clinical Systems Selectra analyzers.It is not intended for use in Point of Care settings. | |
| Indication for use | Measurements of the levels of bilirubin, an organic compound formed duringthe normal and abnormal destruction of red blood cells, are used in thediagnosis and treatment of liver, hemolytic hematological, and metabolicdisorders, including hepatitis and gall bladder block | |
| ELITech Clinical Systems DeviceBILIRUBIN TOTAL 4+1 | Predicate device(ABX PENTRA BILIRUBIN, TOTAL CPK060325) | |
| Intended use | Intended for the quantitative in vitrodiagnostic determination of totalbilirubin in human serum andplasma on ELITech ClinicalSystems Selectra analyzers.It is not intended for use in Point ofCare settings. | Intended for use with associatedcalibrators and controls for quantitativein vitro diagnostic determination of totalbilirubin in human serum and plasmaon ABX PENTRA 400 ClinicalChemistry Analyzer. |
| Indication for Use | Measurements of the levels ofbilirubin, an organic compoundformed during the normal andabnormal destruction of red bloodcells, are used in the diagnosis andtreatment of liver, hemolytichematological, and metabolicdisorders, including hepatitis andgall bladder block. | Measurements of the levels of bilirubin,an organic compound formed duringthe normal and abnormal destruction ofred blood cells, are used in thediagnosis and treatment of liver,hemolytic hematological, and metabolicdisorders, including hepatitis and gallbladder block. |
| Assay protocol | Malloy-Evelyn modified method | Photometric test using 2,4-dichloroaniline (DCA) and a specificmixture of detergents |
| Composition | Reagent 1 :Sulfanilic acid 29 mmol/LHydrochloric acid 67 mmol/LCetrimide 37 mmol/L | Reagent 1 :Phosphate buffer 50 mmol/LNaCl 150 mmol/LDetergents , Stabilizers |
| Reagent 2 :Sodium nitrite 5.8 mmol/L | Reagent 2 :2,4-Dichlorophenyl -diazonium salt 5 mmol/LHCI 130 mmol/LDetergent | |
| Appearance of reagent | Liquid form, ready to use | Liquid form, ready to use |
| Sample type | SerumLithium heparin plasma | SerumPlasma in lithium heparin |
| Reagent storage | Store at 2-8 °C and protect fromlight. The reagent is stable until theexpiry date stated on the label. | Reagents, in unopened cassette, arestable up to expiry date on the label ifstored at 2-8°C and contamination isavoided. |
| Expected values | Adults: 0.3 - 1.2 mg/dL | Adults : 0.1 - 1.2 mg/dL |
| Instrument | Selectra ProM | ABX PENTRA 400 |
| Measuring range | 0.28 to 20.22 mg/dL | 0.2 to 26.3 mg/dL |
| Limit of detection (LoD) | 0.06 mg/dL | 0.09 mg/dL |
| Limit of quantification (LoQ) | 0.17 mg/dL | 0.14 mg/dL |
| Precision | Within runLevel 1.04 mg/dL CV=2.7%Level 3.67 mg/dL CV=0.8%Level 14.90 mg/dLCV=0.5% | Within runLevel 0.97 mg/dL CV=2.14%Level 5.13 mg/dL CV=0.99%Level 0.61 mg/dL CV=3.09%Level 0.85 mg/dL CV=2.23%Level 2.20 mg/dL CV=1.33% |
| ELITech Clinical Systems DeviceBILIRUBIN TOTAL 4+1 | Predicate device(ABX PENTRA BILIRUBIN, TOTAL CPK060325) | |
| TotalLevel 1.04 mg/dL CV=4.0%Level 3.67 mg/dL CV=2.0%Level 14.90 mg/dL CV=1.8% | TotalLevel 1.0 mg/dL CV=4.04%Level 5.5 mg/dL CV=1.70%Level 0.8 mg/dL CV=5.97%Level 2.9 mg/dL CV=2.78%Level 9.1 mg/dL CV=2.20% | |
| Method comparison | y=0.924x + 0.02 mg/dL$r^2$ = 0.998range: 0.25 to 22.00 mg/dL | y=1.03x - 0.14 mg/dL$r^2$ = 0.9965range: 0.3 to 25.8 mg/dL |
| Limitations | Triglycerides: No significantinterference up to 2779 mg/dLHemoglobin:No significant interference up to500 mg/dL.Acetaminophen: No significantinterference up to 30 mg/dL.Ascorbic acid:Concentrations greater than 2.0mg/dL will interfere and causeerroneous results.Acetylsalicylic acid:No significant interference up to200 mg/dL | Hemoglobin: No significant influenceis observed up to 500 mg/dL.Triglycerides: No significant influenceis observed up to 612.5 mg/dL (asIntralipid®, representative of lipemia). |
| Calibration Frequency | 28 days | 10 days |
| On board stability | refrigerated area : 28 days | refrigerated area: 25 days |
| Calibrator | Recommended calibration material(not included):ELITech Clinical Systems ELICAL 2 | Recommended calibration material (notincluded):ABX Pentra Multical |
| Controls | Recommended quality controlmaterial (not included):ELITech Clinical Systems ELITROLI (Normal control)ELITech Clinical Systems ELITROLII (Pathologic control) | Recommended quality control material(not included):ABX Pentra N Control(Normal control)ABX Pentra P Control (Pathologiccontrol) |
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| Device names | |
|---|---|
| REAGENT:Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems BILIRUBIN DIRECT 4+1Bilirubin direct, "BILIRUBIN DIRECT 4+1"Class IIBilirubin (Total or Direct) test System (Sec.862.1110)CIG - Diazo Colorimetry, Bilirubin |
| Predicate device | ABX PENTRA BILIRUBIN, DIRECT CP (K060325) |
| Device description | The device for this submission is available as kit only. It consists of 2reagents, "R1" and "R2".Reagent R1 contains sulfanilic acid and Hydrochloric acid.Reagent R2 contains sodium nitrite. |
| Intended Use | ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended thequantitative in vitro diagnostic determination of direct bilirubin in humanserum and plasma on ELITech Clinical Systems Selectra analyzers.It is not intended for use in Point of Care settings. |
| Indication for use | Measurements of the levels of bilirubin, an organic compound formed duringthe normal and abnormal destruction of red blood cells, are used in thediagnosis and treatment of liver, hemolytic hematological, and metabolicdisorders, including hepatitis and gall bladder block |
| ELITech Clinical Systems DeviceBILIRUBIN DIRECT 4+1 | Predicate device(ABX PENTRA BILIRUBIN, DIRECT CPK060325) | |
|---|---|---|
| Intended use | Intended for the quantitative invitro diagnostic determination ofdirect bilirubin in human serum andplasma on ELITech ClinicalSystems Selectra analyzers.It is not intended for use in Point ofCare settings. | Intended for use with associated calibratorsand controls for quantitative in vitro diagnosticdetermination of direct bilirubin in humanserum and plasma on ABX PENTRA 400Clinical Chemistry Analyzer. |
| Indication for Use | Measurements of the levels ofbilirubin, an organic compoundformed during the normal andabnormal destruction of red bloodcells, are used in the diagnosisand treatment of liver, hemolytichematological, andmetabolicdisorders, including hepatitis andgall bladder block | Measurements of the levels of bilirubin, anorganic compound formed during the normaland abnormal destruction of red blood cells,are used in the diagnosis and treatment ofliver, hemolytic hematological, and metabolicdisorders, including hepatitis and gall bladderblock |
| Assay protocol | Malloy-Evelyn modified method | Photometric test using2,4-dichloroaniline(DCA) |
| Composition | Reagent 1:Sulfanilic acid$29$ mmol/LHydrochloric acid$67$ mmol/L | Reagent 1:Sulfamic acid$100$ mmol/LEDTA-Na2$0.1$ mmol/LNaCl$150$ mmol/L |
| ELITech Clinical Systems DeviceBILIRUBIN DIRECT 4+1 | Predicate device(ABX PENTRA BILIRUBIN, DIRECT CPK060325) | |
| Reagent 2 :Sodium nitrite 5.8 mmol/L | Reagent 2 :2,4-Dichlorophenyl -diazonium salt 0.5 mmol/LHCI 900 mmol/LEDTA-Na2 0.13 mmol/L | |
| Appearance of reagent | Liquid form, ready to use | Liquid form, ready to use |
| Sample type | SerumLithium heparin plasma | SerumPlasma in lithium heparin |
| Reagent storage | Store at 2-8 °C and protect fromlight. The reagent is stable until theexpiry date stated on the label. | Reagents, in unopened cassette, are stable upto expiry date on the label if stored at 2-8°Cand contamination is avoided. |
| Expected values | < 0.2 mg/dL | ≤ 0.2 mg/dL |
| Instrument | Selectra ProM | ABX PENTRA 400 |
| Measuring range | 0.18 to 6.82 mg/dL | 0.09 to 6.71 mg/dL |
| Limit of detection (LoD) | 0.06 mg/dL | 0.04 mg/dL |
| Limit of quantification (LoQ) | 0.17 mg/dL | 0.04 mg/dL |
| Precision | Within runLevel 0.49 mg/dL CV=2.0%Level 1.89 mg/dL CV=0.6%Level 4.96 mg/dL CV=0.5% | Within runLevel 0.90 mg/dL CV=0.67%Level 1.85 mg/dL CV=0.44%Level 0.23 mg/dL CV=3.23%Level 1.52 mg/dL CV=0.59%Level 7.88 mg/dL CV=2.69% |
| TotalLevel 0.49 mg/dL CV=4.7%Level 1.89 mg/dL CV=3.3%Level 4.96 mg/dL CV=3.2% | TotalLevel 0.94 mg/dL CV=4.26%Level 2.02 mg/dL CV=4.22%Level 0.69 mg/dL CV=3.27%Level 3.83 mg/dL CV=2.98% | |
| Method comparison | y=0.988x + 0.07 mg/dLr²= 0.974range: 0.10 to 6.23 mg/dL | y=1.06x + 0.04 mg/dLr²= 0.9928range: 0.09 to 6.71 mg/dL |
| Limitations | TriglyceridesNo significant interference up to2106 mg/dLHemoglobin:No significant interference up to125 mg/dL .Acetaminophen: No significantinterference up to 30 mg/dL.Ascorbic acid:Concentrations greater than 0.3mg/dL will interfere and causeerroneous results. | Hemoglobin: do not use hemolyzed samplesTriglycerides: No significant influence isobserved up to 612.5 mg/dL (As Intralipid®,representative of lipemia) |
| ELITech Clinical Systems DeviceBILIRUBIN DIRECT 4+1 | Predicate device(ABX PENTRA BILIRUBIN, DIRECT CPK060325) | |
| No significant interference up to200 mg/dL | ||
| Calibration Frequency | 28 days | 10 days |
| On board stability | refrigerated area : 28 days | refrigerated area: 30 days |
| Calibrator | Recommended calibration material(not included):ELITech Clinical Systems ELICAL2 | Recommended calibration material (notincluded):ABX Pentra Multical |
| Controls | Recommended quality controlmaterial (not included):ELITech Clinical SystemsELITROL I (Normal control)ELITech Clinical SystemsELITROL II (Pathologic control) | Recommended quality control material (notincluded):ABX Pentra N Control(Normal control)ABX Pentra P Control (Pathologic control) |
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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 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. |
| Intended 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 ELITech Clinical Systems Selectra analyzers. |
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| ELITech Clinical Systems Device(ELICAL 2) | Predicate device(Roche Calibrator f.a.s. K033501) | |
|---|---|---|
| Intended use | ELITech Clinical Systems ELICAL 2is a multi-parametric calibrator for in vitro diagnostic use in the calibrationof quantitative ELITech ClinicalSystems methods on the ELITechClinical Systems Selectra analyzers. | For in vitro diagnostic use in thecalibration of quantitative Rochemethods on Roche clinical chemistryanalysers as specified in the valuesheets. |
| Format | Lyophilized calibrator based on humanserum with constituents added asrequired to obtain desired componentslevels | Lyophilized calibrator based on humanserum with constituents added asrequired to obtain desired componentslevels |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding theloss of lyophilizate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam. | Carefully open one bottle, avoiding theloss of lyophilizate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation of foam. |
| Traceability | Traceability information is given in thevalue sheet included in the box. | Traceability of the target value is givenin the respective instruction for use ofthe system reagents. |
| Stability | Lyophilized:To store at 2-8℃ and protected fromlight until the expiry dateAfter reconstitution, the stabilities are :- Stability of direct bilirubin (whenstored protected from light): | Lyophilized:Stable at 2-8℃ up to expiration date.After reconstitution, the stabilities* are :- Stability of direct bilirubin (whenstored protected from light): |
| Between 15-25 ℃:3 hours | Between 15-25 ℃:3 hours | |
| Between 2-8 ℃:8 hoursBetween -25 and -15 ℃: 2 weeks(when frozen once) | Between 2-8 ℃8 hoursBetween (-25)-(-15) ℃: 2 weeks (whenfrozen once) | |
| - Stability of total bilirubin (when storedprotected from light): | - Stability of total bilirubin (when storedprotected from light): | |
| Between 15-25 ℃:6 hours | Between 15-25 ℃:6 hours | |
| Between 2-8 ℃:1 dayBetween -25 and -15 ℃: 2 weeks(when frozen once) | Between 2-8 ℃:1 dayBetween (-25)-(-15) ℃: 2 weeks(when frozen once) |
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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 CFR 862.1660)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 & ELITROL II are multi parametric |
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric intended Use control sera for in vitro diagnostic use in quality control of ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
| Intended use | ELITech Clinical Systems DeviceELITROL I/ELITROL II | Predicate DeviceRoche Precinorm U/ Precipath UK041227 |
|---|---|---|
| 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 lyophilizate, and pipette in exactly 5mL of distilled/deionized water. Carefullyclose the vial and dissolve the contentscompletely by occasional gentle swirlingwithin 30 minutes avoiding the formationof foam. | For in vitro diagnostic use in qualitycontrol by monitoring accuracy andprecision for the quantitative methodsas specified in the value sheet. |
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| Stability | Lyophilized:To store at 2-8°C and protected fromlight until the expiry dateAfter reconstitution, the stabilities are : | Lyophilized:Stable at 2-8°C up to expiration date.- Stability of direct bilirubin (whenstored protected from light): |
|---|---|---|
| - Stability of direct bilirubin (when storedprotected from light):Between 15-25 °C: 4 hoursBetween 2-8 °C: 8 hoursBetween -25 and -15 °C: 2 weeks(when frozen once) | Between 15-25 °C: 4 hoursBetween 2-8 °C: 8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)- Stability of total bilirubin (when storedprotected from light): | |
| - Stability of total bilirubin (when storedprotected from light):Between 15-25 °C: 8 hoursBetween 2-8 °C: 24 hoursBetween -25 and -15 °C: 2 weeks(when frozen once) | Between 15-25 °C: 8 hoursBetween 2-8 °C: 24 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once) |
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
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Image /page/9/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of several curved lines. The overall design is simple and monochromatic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
ELITech Group c/o Debra Hutson 21720 23td Dr. SE. Suite 150 Bothell. Washington 98021
Food and Druq Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Re: K110780 Trade Name: ELITech Clinical Systems Bilirubin Total 4+1, ELITech Clinical Systems Bilirubin Direct 4+1. ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL. I and ELITROL H Regulation Number: 21 CFR §862.1110 Regulation Name: Bilirubin Test System Regulatory Class: Class H Product Codes: CIG. JIX and JJY Dated: September 12, 2011 Received: September 14, 2011
OCT - 7 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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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 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/ResourcesSorYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K110780
Device Name: _________________________________________________________________________________________________________________________________________________________________ ELITech Clinical Systems BILIRUBIN TOTAL 4+1
Indications for Use:
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELITech Clinical Systems Selectra analyzers.
It is not intended for use in Point of Care settings.
Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
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)
Rate Chen
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 110780
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510(k) Number (if known):
ELITech Clinical Systems BILIRUBIN DIRECT 4+1 Device Name:
Indications for Use:
ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra analyzers.
It is not intended for use in Point of Care settings.
Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
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 (OVD)
Ruta Cime
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
11 2780 510(k)
Page Zof 4
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510(k) Number (if known): _ _ K | 10780
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 ELITech Clinical Systems Selectra analyzers.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rutul Chosler
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
いいつでない 510(k)
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510(k) Number (if known): _ K 110780
ELITech Clinical Systems ELITROL I & ELITROL II Device Name:
Indications for Use:
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Rute chere
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
11 07 8 0 510(k)
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§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.