(200 days)
Not Found
No
The device description and performance studies focus on chemical reagents and their analytical performance, with no mention of AI or ML.
No.
Explanation: The device is intended for in vitro diagnostic determination of bilirubin levels, used in the diagnosis and treatment of conditions, not for direct therapeutic intervention. It is an analytical tool, not a treatment device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "intended for the quantitative in vitro diagnostic determination" of bilirubin and that measurements are "used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders".
No
The device description clearly states that the device consists of reagent kits (R1 and R2) and lyophilized calibrators and control sera, which are physical components, not software.
Yes, based on the provided text, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section for all listed devices (BILIRUBIN TOTAL 4+1, BILIRUBIN DIRECT 4+1, ELICAL 2, ELITROL I & ELITROL II) explicitly states that they are intended for "in vitro diagnostic" use.
- Purpose of the Devices: The descriptions clearly indicate that these devices are used to analyze human samples (serum and plasma) to provide information for the diagnosis and treatment of medical conditions (liver, hemolytic hematological, and metabolic disorders). This is the core function of an IVD.
- Device Description: The description of the reagents, calibrator, and control sera aligns with the components typically found in IVD kits used for clinical chemistry analysis.
- Performance Studies: The mention of performance studies like precision and method comparison are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The listed predicate devices are also IVDs (indicated by their names and K numbers, which are associated with FDA clearances for medical devices, including IVDs).
N/A
Intended Use / Indications for Use
ELITech Clinical Systems BILIRUBIN TOTAL 4+1: 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: 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: 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: 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.
Product codes
CIG, JIX, JJY
Device Description
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: 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: 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ELITech Clinical Systems BILIRUBIN TOTAL 4+1:
Limit of detection (LoD): 0.06 mg/dL
Limit of quantification (LoQ): 0.17 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/dL CV=0.5%
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%
Method comparison: y=0.924x + 0.02 mg/dL, r Squared = 0.998, range: 0.25 to 22.00 mg/dL
ELITech Clinical Systems BILIRUBIN DIRECT 4+1:
Limit of detection (LoD): 0.06 mg/dL
Limit of quantification (LoQ): 0.17 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%
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%
Method comparison: y=0.988x + 0.07 mg/dL, r squared= 0.974, range: 0.10 to 6.23 mg/dL
Predicate Device(s)
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 (K041227), Roche Diagnostics Precipath U (K041227)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 | 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).
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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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