ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II

Q: Who is the manufacturer of ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II?

Elitechgroup filed the 510(k) submission for ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II (K110780).

Q: What is the FDA product code for ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II?

CIG. It is classified under 21 CFR 862.1110 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II?

ABX PENTRA BILIRUBIN, TOTAL CP (k060325); ABX PENTRA BILIRUBIN, DIRECT CP (k060325); Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k033501); Roche Diagnostics Precinorm U and Precipath U (k041227).

Q: Who can help prepare an FDA 510(k) submission like ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K110780 · Elitechgroup · CIG · Oct 7, 2011 · Clinical Chemistry

Device Facts

Record ID	K110780
Device Name	ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
Applicant	Elitechgroup
Product Code	CIG · Clinical Chemistry
Decision Date	Oct 7, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1110
Device Class	Class 2

Intended 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. 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. 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.

Device Story

ELITech Clinical Systems Bilirubin Total 4+1 and Bilirubin Direct 4+1 are in vitro diagnostic reagent kits used on Selectra analyzers. The system utilizes a modified Malloy-Evelyn method (diazo colorimetry) to measure bilirubin levels in human serum or plasma. Reagents (R1 and R2) are mixed with the patient sample; the resulting colorimetric change is measured photometrically by the analyzer. The output is a quantitative bilirubin concentration (mg/dL). These results assist clinicians in diagnosing and monitoring liver, hemolytic, and metabolic conditions. The system includes ELICAL 2 (lyophilized human serum calibrator) and ELITROL I/II (lyophilized human serum quality controls) to ensure measurement accuracy and precision. The device is intended for professional use in clinical laboratory settings, not for point-of-care.

Clinical Evidence

Bench testing only. Performance validated via precision (Total CV < 4.7%), linearity (Total: 0.28-20.22 mg/dL; Direct: 0.18-6.82 mg/dL), and interference studies (CLSI EP07-A2). Method comparison against predicate (n=100) showed high correlation (Total R²=0.998; Direct R²=0.974). Matrix comparison confirmed suitability of lithium heparin plasma.

Technological Characteristics

Diazo colorimetry (Malloy-Evelyn modified method). Reagents are liquid, ready-to-use. Calibrator and controls are lyophilized human serum-based. Analyzers: Selectra ProM. Connectivity: Standalone clinical chemistry analyzer. Storage: 2-8°C, protected from light.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of total and direct bilirubin in human serum and plasma to aid in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders (e.g., hepatitis, gall bladder blockage). For prescription use only; not for Point of Care settings.

Regulatory Classification

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.

Predicate Devices

ABX PENTRA BILIRUBIN, TOTAL CP (k060325)
ABX PENTRA BILIRUBIN, DIRECT CP (k060325)
Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k033501)
Roche Diagnostics Precinorm U and Precipath U (k041227)

Related Devices

K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 · Elitechgroup · Jul 11, 2017
K040631 — VITALAB DIRECT BILIRUBIN REAGENT · Clinical Data, Inc. · Mar 18, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ ﻟﺴﻴﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ・ - OCT - 7 2011 ## SECTION 5 - 510(k) Summary | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | | |---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The assigned 510(k) number is: K110780 | | | Submitter Address Phone number Fax 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 Class Classification name Product code | ELITech Clinical Systems BILIRUBIN TOTAL 4+1 Bilirubin total, "BILIRUBIN TOTAL 4+1" Class II Bilirubin (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 2 reagents, "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 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. | | | Indication for use | 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 block | | | | ELITech Clinical Systems Device BILIRUBIN TOTAL 4+1 | Predicate device (ABX PENTRA BILIRUBIN, TOTAL CP K060325) | | Intended use | 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. | Intended for use with associated calibrators and controls for quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ABX PENTRA 400 Clinical Chemistry Analyzer. | | Indication for Use | 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 block. | 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 block. | | Assay protocol | Malloy-Evelyn modified method | Photometric test using 2,4- dichloroaniline (DCA) and a specific mixture of detergents | | Composition | Reagent 1 : Sulfanilic acid 29 mmol/L Hydrochloric acid 67 mmol/L Cetrimide 37 mmol/L | Reagent 1 : Phosphate buffer 50 mmol/L NaCl 150 mmol/L Detergents , Stabilizers | | | Reagent 2 : Sodium nitrite 5.8 mmol/L | Reagent 2 : 2,4-Dichlorophenyl - diazonium salt 5 mmol/L HCI 130 mmol/L Detergent | | Appearance of reagent | Liquid form, ready to use | Liquid form, ready to use | | Sample type | Serum Lithium heparin plasma | Serum Plasma in lithium heparin | | Reagent storage | Store at 2-8 °C and protect from light. The reagent is stable until the expiry date stated on the label. | Reagents, in unopened cassette, are stable up to expiry date on the label if stored at 2-8°C and contamination is avoided. | | 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 run Level 1.04 mg/dL CV=2.7% Level 3.67 mg/dL CV=0.8% Level 14.90 mg/dLCV=0.5% | Within run Level 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 Device BILIRUBIN TOTAL 4+1 | Predicate device (ABX PENTRA BILIRUBIN, TOTAL CP K060325) | | | Total Level 1.04 mg/dL CV=4.0% Level 3.67 mg/dL CV=2.0% Level 14.90 mg/dL CV=1.8% | Total Level 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 $r^2$ = 0.998 range: 0.25 to 22.00 mg/dL | y=1.03x - 0.14 mg/dL $r^2$ = 0.9965 range: 0.3 to 25.8 mg/dL | | Limitations | Triglycerides: No significant interference up to 2779 mg/dL Hemoglobin: No significant interference up to 500 mg/dL. Acetaminophen: No significant interference up to 30 mg/dL. Ascorbic acid: Concentrations greater than 2.0 mg/dL will interfere and cause erroneous results. Acetylsalicylic acid: No significant interference up to 200 mg/dL | Hemoglobin: No significant influence is observed up to 500 mg/dL. Triglycerides: No significant influence is observed up to 612.5 mg/dL (as Intralipid®, 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 (not included): ABX Pentra Multical | | 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): ABX Pentra N Control (Normal control) ABX Pentra P Control (Pathologic control) | :: .. {1}------------------------------------------------ {2}------------------------------------------------ {3}------------------------------------------------ | Device names | | |---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | REAGENT: Trade/proprietary Name: Common or Usual Name: Device Class Classification name Product code | ELITech Clinical Systems BILIRUBIN DIRECT 4+1 Bilirubin direct, "BILIRUBIN DIRECT 4+1" Class II Bilirubin (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 2 reagents, "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 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. | | Indication for use | 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 block | | | ELITech Clinical Systems Device BILIRUBIN DIRECT 4+1 | Predicate device (ABX PENTRA BILIRUBIN, DIRECT CP K060325) | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | 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. | Intended for use with associated calibrators and controls for quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ABX PENTRA 400 Clinical Chemistry Analyzer. | | Indication for Use | 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 block | 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 block | | Assay protocol | Malloy-Evelyn modified method | Photometric test using 2,4-dichloroaniline (DCA) | | Composition | Reagent 1: Sulfanilic acid $29$ mmol/L Hydrochloric acid $67$ mmol/L | Reagent 1: Sulfamic acid $100$ mmol/L EDTA-Na2 $0.1$ mmol/L NaCl $150$ mmol/L | | | ELITech Clinical Systems Device BILIRUBIN DIRECT 4+1 | Predicate device (ABX PENTRA BILIRUBIN, DIRECT CP K060325) | | | Reagent 2 : Sodium nitrite 5.8 mmol/L | Reagent 2 : 2,4-Dichlorophenyl - diazonium salt 0.5 mmol/L HCI 900 mmol/L EDTA-Na2 0.13 mmol/L | | Appearance of reagent | Liquid form, ready to use | Liquid form, ready to use | | Sample type | Serum Lithium heparin plasma | Serum Plasma in lithium heparin | | Reagent storage | Store at 2-8 °C and protect from light. The reagent is stable until the expiry date stated on the label. | Reagents, in unopened cassette, are stable up to expiry date on the label if stored at 2-8°C and 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 run Level 0.49 mg/dL CV=2.0% Level 1.89 mg/dL CV=0.6% Level 4.96 mg/dL CV=0.5% | Within run Level 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% | | | Total Level 0.49 mg/dL CV=4.7% Level 1.89 mg/dL CV=3.3% Level 4.96 mg/dL CV=3.2% | Total Level 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/dL r²= 0.974 range: 0.10 to 6.23 mg/dL | y=1.06x + 0.04 mg/dL r²= 0.9928 range: 0.09 to 6.71 mg/dL | | Limitations | Triglycerides No significant interference up to 2106 mg/dL Hemoglobin: No significant interference up to 125 mg/dL . Acetaminophen: No significant interference up to 30 mg/dL. Ascorbic acid: Concentrations greater than 0.3 mg/dL will interfere and cause erroneous results. | Hemoglobin: do not use hemolyzed samples Triglycerides: No significant influence is observed up to 612.5 mg/dL (As Intralipid®, representative of lipemia) | | | ELITech Clinical Systems Device BILIRUBIN DIRECT 4+1 | Predicate device (ABX PENTRA BILIRUBIN, DIRECT CP K060325) | | | No significant interference up to 200 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 ELICAL 2 | Recommended calibration material (not included): ABX Pentra Multical | | 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): ABX Pentra N Control (Normal control) ABX Pentra P Control (Pathologic control) | {4}------------------------------------------------ {5}------------------------------------------------ #### 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. | {6}------------------------------------------------ | | ELITech Clinical Systems Device (ELICAL 2) | Predicate device (Roche Calibrator f.a.s. K033501) | |--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 the ELITech Clinical Systems Selectra analyzers. | For in vitro diagnostic use in the calibration of quantitative Roche methods on Roche clinical chemistry analysers as specified in the value sheets. | | Format | Lyophilized calibrator based on human serum with constituents added as required to obtain desired components levels | Lyophilized calibrator based on human serum with constituents added as required to obtain desired components levels | | Level | Single level | Single level | | Handling | Carefully open the vial, avoiding the loss of lyophilizate, and pipette in exactly 3 mL of distilled/deionized water. Carefully close the vial and dissolve the contents completely by occasional gentle swirling within 30 minutes avoiding the formation of foam. | Carefully open one bottle, avoiding the loss of lyophilizate, and pipette in exactly 3 mL of distilled/deionized water. Carefully close the bottle and dissolve the contents completely by occasional gentle swirling within 30 minutes. Avoid the formation of foam. | | Traceability | Traceability information is given in the value sheet included in the box. | Traceability of the target value is given in the respective instruction for use of the system reagents. | | Stability | Lyophilized: To store at 2-8℃ and protected from light until the expiry date After reconstitution, the stabilities are : - Stability of direct bilirubin (when stored protected from light): | Lyophilized: Stable at 2-8℃ up to expiration date. After reconstitution, the stabilities* are : - Stability of direct bilirubin (when stored protected from light): | | | Between 15-25 ℃: 3 hours | Between 15-25 ℃: 3 hours | | | Between 2-8 ℃: 8 hours Between -25 and -15 ℃: 2 weeks (when frozen once) | Between 2-8 ℃ 8 hours Between (-25)-(-15) ℃: 2 weeks (when frozen once) | | | - Stability of total bilirubin (when stored protected from light): | - Stability of total bilirubin (when stored protected from light): | | | Between 15-25 ℃: 6 hours | Between 15-25 ℃: 6 hours | | | Between 2-8 ℃: 1 day Between -25 and -15 ℃: 2 weeks (when frozen once) | Between 2-8 ℃: 1 day Between (-25)-(-15) ℃: 2 weeks (when frozen once) | {7}------------------------------------------------ #### Device names · | CONTROLS: Trade/proprietary Name: Common or Usual Name: Device Class Classification name Product code | ELITech Clinical Systems ELITROL I and ELITROL II Multi-analyte controls - all kinds, "ELITROL I"- "ELITROL II" Class I Quality 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 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. | | 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 Device ELITROL I/ELITROL II | Predicate Device Roche Precinorm U/ Precipath U K041227 | |--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Format | Lyophilized human sera with constituents added as required to obtain desired components levels | Lyophilized human sera with constituents added as required to obtain desired components levels | | Levels | Two levels | Two levels | | Handling | Carefully open the vial, avoiding the loss of lyophilizate, and pipette in exactly 5 mL of distilled/deionized water. Carefully close the vial and dissolve the contents completely by occasional gentle swirling within 30 minutes avoiding the formation of foam. | For in vitro diagnostic use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheet. | {8}------------------------------------------------ | Stability | Lyophilized: To store at 2-8°C and protected from light until the expiry date After reconstitution, the stabilities are : | Lyophilized: Stable at 2-8°C up to expiration date. - Stability of direct bilirubin (when stored protected from light): | |-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | - Stability of direct bilirubin (when stored protected from light): Between 15-25 °C: 4 hours Between 2-8 °C: 8 hours Between -25 and -15 °C: 2 weeks (when frozen once) | Between 15-25 °C: 4 hours Between 2-8 °C: 8 hours Between (-25)-(-15) °C: 2 weeks (when frozen once) - Stability of total bilirubin (when stored protected from light): | | | - Stability of total bilirubin (when stored protected from light): Between 15-25 °C: 8 hours Between 2-8 °C: 24 hours Between -25 and -15 °C: 2 weeks (when frozen once) | Between 15-25 °C: 8 hours Between 2-8 °C: 24 hours Between (-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. . {9}------------------------------------------------ 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). {10}------------------------------------------------ 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 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 {11}------------------------------------------------ 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 {12}------------------------------------------------ 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 {13}------------------------------------------------ 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) {14}------------------------------------------------ 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) Page of of 4

ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II

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ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II

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