(223 days)
Not Found
No
The document describes in vitro diagnostic reagents and calibrators for use on specific analyzers. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance data presented is standard for chemical assays (precision and method comparison).
No
The device is described as an "in vitro diagnostic" device, specifically for the quantitative determination of triglycerides and cholesterol in human serum and plasma, which is used for diagnosis and monitoring, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are for "quantitative in vitro diagnostic determination" and that the measurements are "used in the diagnosis and treatment of patients".
No
The device description explicitly states it is a "kit only" consisting of reagents and calibrators/controls, which are physical components, not software.
Yes, based on the provided text, these devices are In Vitro Diagnostics (IVDs).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section for both TRIGLYCERIDES SL and CHOLESTEROL SL explicitly states they are "intended for the quantitative in vitro diagnostic determination of triglycerides/cholesterol in human serum and plasma".
- Explicit Statement for Calibrator and Controls: The "Intended Use / Indications for Use" section for ELICAL 2 and ELITROL I & ELITROL II also explicitly states they are for "in vitro diagnostic use".
- Purpose of Measurements: The intended use describes how the measurements are used in the "diagnosis and treatment of patients" with various conditions related to lipid metabolism and endocrine disorders. This is a key characteristic of IVDs.
- Analysis of Human Specimens: The devices are intended for use with "human serum and plasma," which are biological specimens.
- Use in a Laboratory Setting: The devices are intended for use on specific laboratory analyzers (ELITech Vital Scientific Selectra/Flexor analyzers) and are explicitly stated as "not intended for use in Point of Care settings," further indicating a laboratory-based diagnostic use.
Therefore, the text clearly identifies these devices as intended for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
ELITech Clinical Systems TRIGLYCERIDES SL:
ELITech Clinical Systems TRIGLYCERIDES SL is intended for the quantitative in vitro diagnostic determination of triglycerides in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
ELITech Clinical Systems CHOLESTEROL SL:
ELITech Clinical Systems CHOLESTEROL SL is intended for the quantitative in vitro diagnostic determination of cholesterol in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
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 the ELITech Vital Scientific Selectra/Flexor Analyzers.
ELITech Clinical Systems ELITROL I and ELITROL II:
ELITech Clinical Systems ELITROL I & ELITROL II are multiparametric control sera for use in quality control of ELITech Clinical Systems methods on ELITech Vital Scientific Selectra/Flexor Analyzers.
Product codes
CDT, CHH, JIX, JJY
Device Description
ELITech Clinical Systems TRIGLYCERIDES SL:
The device for this submission is available as kit only. It consists of 1 reagent, "R". Reagent R contains: Pipes buffer, p-chlorophenol, ATP, Amino-4-antipyrine (4-AAP), Lipoprotein lipase (bacterial), Glycerol kinase (bacterial), Glycerol-3-phosphate oxidase (microorganisms), Peroxidase (horseradish), Potassium ferrocyanide, Magnesium (Mg2+) and Sodium azide.
ELITech Clinical Systems CHOLESTEROL SL:
The device for this submission is available as kit only. It consists of 1 reagent, "R". Reagent R contains: Pipes buffer, 4-Aminoantipyrine (4-AAP), Cholesterol esterase (CHE bacterial), Cholesterol oxidase (CHO microorganisms), Peroxidase (POD horseradish), Sodium cholate, Phenol and Sodium azide.
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)
ELITech Clinical Systems TRIGLYCERIDES SL:
- Precision:
- Within run: Level 48 mg/dL CV=1.5%, Level 142 mg/dL CV=1.0%, Level 273 mg/dL CV=0.7%
- Total: Level 48 mg/dL CV=3.9%, Level 142 mg/dL CV=2.7%, Level 273 mg/dL CV=4.5%
- Method comparison: y=1.040x + 0.339 mg/dL, r²= 0.998, range: 22 to 936 mg/dL
- Limitations:
- Unconjugated bilirubin: No significant interference up to 15 mg/dL.
- Conjugated bilirubin: No significant interference up to 5.9 mg/dL
- Hemoglobin: No significant interference up to 250 mg/dL.
- Uric acid: No significant interference up to 23.6 mg/dL
- Ascorbic acid: No significant interference up to 2.0 mg/dL. Concentrations above the therapeutic levels will interfere and cause erroneous results.
- Methyl-dopa: No significant interference up to 1.0 mg/dL
ELITech Clinical Systems CHOLESTEROL SL:
- Precision:
- Within run: Level 116 mg/dL CV=2.4%, Level 190 mg/dL CV=1.9%, Level 298 mg/dL CV=1.7%
- Total: Level 116 mg/dL CV=2.6%, Level 190 mg/dL CV=2.7%, Level 298 mg/dL CV=2.7%
- Method comparison: y=1.006 x - 1.734 mg/dL, r² = 0.999, range: 20 to 579 mg/dL
- Limitations:
- Unconjugated bilirubin: No significant interference up to 6.0 mg/dL.
- Conjugated bilirubin: No significant interference up to 5.9 mg/dL.
- Hemoglobin: No significant interference up to 250 mg/dL.
- Turbidity: No significant interference up to 614 mg/dL triglyceride equivalent.
- Ascorbic acid: No significant interference up to 2.0 mg/dL. Concentrations above the therapeutic levels will interfere and cause erroneous results.
- Methyl-dopa: No significant interference up to 0.8 mg/dL. Concentrations above the therapeutic levels will interfere and cause erroneous results.
- Uric acid: No significant interference up to 23.4 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ABX PENTRA TRIGLYCERIDES CP (K060854), ABX PENTRA CHOLESTEROL CP (K060854), 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
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
.
| SECTION 5 - 510(k) Summary
| ELITech Clinical Systems TRIGLYCERIDES SL reagent MAY 19 2011 | ||
|---|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information | |
| provides sufficient detail to understand the basis for a determination of sub- | ||
| stantial equivalence. | ||
| The assigned 510(k) number is: K102993 | ||
| 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) | |
| Date of Preparation | September 30th, 2010 | |
| Device name | | |
| REAGENT :
Trade/proprietary Name:
Common or Usual Name:
Device Class
Classification name
Product code | ELITech Clinical Systems TRIGLYCERIDES SL
Triglycerides, "TRIGLYCERIDES SL"
Class I
Triglyceride test system (Sec.862.1705)
CDT - Lipase Hydrolysis/Glycerol kinase enzyme, Triglycerides | |
| Predicate device | ABX PENTRA TRIGLYCERIDES CP (K060854) | |
| Device description | The device for this submission is available as kit only. It consists of 1
reagent, "R".
Reagent R contains: Pipes buffer, p-chlorophenol, ATP, Amino-4-antipyrine
(4-AAP), Lipoprotein lipase (bacterial), Glycerol kinase (bacterial), Glycerol-
3-phosphate oxidase (microorganisms), Peroxidase (horseradish), Potas-
sium ferrocyanide, Magnesium (Mg2+) and Sodium azide. | |
| Intended Use | ELITech Clinical Systems TRIGLYCERIDES SL is intended for the quantita-
tive in vitro diagnostic determination of triglycerides in human serum and
plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not in-
tended for use in Point of Care settings | |
| Indication for use | ELITech Clinical Systems TRIGLYCERIDES SL is intended to measure
triglycerides in human serum and plasma. Triglycerides measurements are
used in the diagnosis and treatment of patients with diabetes mellitus, neph-
rosis, liver obstruction, other diseases involving lipid metabolism, or various
endocrine disorders. | |
1
| | ELITech Clinical Systems Device
TRIGLYCERIDES SL | Predicate device
(ABX PENTRA TRIGLYCERIDES CP) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For in vitro diagnostic use in the quan-
titative determination of triglycerides in
serum or plasma on ELITech Vital
Scientific Selectra/Flexor analyzers. It
is not intended for use in Point of Care
settings. | For in vitro diagnostic use in the quan-
titative determination of triglycerides in
serum or plasma. |
| Indication for Use | Intended to measure triglycerides in
human serum and plasma. Triglyc-
erides measurements are used in the
diagnosis and treatment of patients
with diabetes mellitus, nephrosis, liver
obstruction, other diseases involving
lipid metabolism, or various endocrine
disorders. | Intended to measure triglycerides in
human serum and plasma. Triglyc-
erides measurements are used in the
diagnosis and treatment of patients
with diabetes mellitus, nephrosis, liver
obstruction, other diseases involving
lipid metabolism, or various endocrine
disorders. |
| Assay protocol | Enzymatic colorimetric test | Enzymatic colorimetric test |
| Composition | Reagent:
Pipes buffer 50 mmol/L ;
Magnesium (Mg 2+) 14.8 mmol/L :
p-chlorophenol 2.7 mmol/L ;
ATP 3.15 mmol/L :
Potassium ferrocyanide 10 µmol/L ;
Amino-4-antipyrine 0.31 mmol/L :
Lipoprotein lipase ≥ 2000 U/L ;
Glycerol kinase ≥ 500 U/L ;
Glycerol-3-phosphate oxidase ≥ 4000 U/L ;
Peroxidase ≥ 500 U/L :
Sodium azide 500 mg/dl |
| Instrument | Vital Scientific SELECTRA JUNIOR | ABX PENTRA 400 |
| Measuring range | 30 to 1000 mg/dL | 3.1 to 1470 mg/dL |
| Precision | Within run
Level 48 mg/dL CV=1.5%
Level 142 mg/dL CV=1.0%
Level 273 mg/dL CV=0.7%
Total | Within run
Level 126 mg/dL CV=2.52%
Level 214 mg/dL CV=0.82%
Level 60 mg/dL CV=2.83%
Level 108 mg/dL CV=1.84%
Level 232 mg/dL CV=1.00%
Total |
| | Level 48 mg/dL CV=3.9% | Level 128 mg/dL CV=1.91% |
| | ELITech Clinical Systems Device
TRIGLYCERIDES SL | Predicate device
(ABX PENTRA TRIGLYCERIDES CP) |
| | Level 142 mg/dL CV=2.7%
Level 273 mg/dL CV=4.5% | Level 216 mg/dL CV=1.70%
Level 132 mg/dL CV=1.57%
Level 243 mg/dL CV=1.37% |
| Method comparison | y=1.040x + 0.339 mg/dL
r²= 0.998
range: 22 to 936 mg/dL | y=0.99x + 0.20 mg/dL
r²= 0.9994
range: 3.1 to 1434.1 mg/dL |
| Limitations | Unconjugated bilirubin:
No significant interference up to 15 mg/dL.
Conjugated bilirubin:
No significant interference up to 5.9 mg/dL
Hemoglobin:
No significant interference up to 250 mg/dL.
Uric acid:
No significant interference up to 23.6 mg/dL
Ascorbic acid:
No significant interference up to 2.0 mg/dL. Concentrations above the therapeutic levels will interfere and cause erroneous results.
Methyl-dopa:
No significant interference up to 1.0 mg/dL | Hemoglobin: No significant influence is observed up to 500 mg/dL.
Total bilirubin: No significant influence is observed up to 22.5 mg/dL.
Direct bilirubin: No significant influence is observed up to 22.5 mg/dL. |
| Calibration Frequency | 14 days | 14 days |
| On board stability | refrigerated area : 28 days | refrigerated area: 48 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) |
2
Device name
REAGENT
| Trade/proprietary Name: | ELITech Clinical Systems CHOLESTEROL SL |
|---|---|
| Common or Usual Name: | Cholesterol (total), "CHOLESTEROL SL" |
| Device Class | Class I |
| Classification name | Cholesterol (total) test system (Sec.862.1175) |
| Product code | CHH - Enzymatic Esterase-Oxidase, Cholesterol |
Predicate device
ABX PENTRA CHOLESTEROL CP (K060854)
3
| Device description | The device for this submission is available as kit only. It consists of 1 reagent, "R".
Reagent R contains: Pipes buffer, 4-Aminoantipyrine (4-AAP), Cholesterol
esterase (CHE bacterial), Cholesterol oxidase (CHO microorganisms), Per-
oxidase (POD horseradish), Sodium cholate, Phenol and Sodium azide. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | ELITech Clinical Systems CHOLESTEROL SL is intended for the quantita-
tive in vitro diagnostic determination of cholesterol in human serum and
plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. |
| Indication for use | ELITech Clinical Systems CHOLESTEROL SL is intended to measure
cholesterol in human serum and plasma. Cholesterol measurements are
used in the diagnosis and treatment of disorders involving excess choles-
terol in the blood and lipid and lipoprotein metabolism disorders. |
| | ELITech Clinical Systems Device
CHOLESTEROL SL | Predicate device
(ABX PENTRA CHOLESTEROL CP) |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For in vitro diagnostic use in the quan-
titative determination of cholesterol in
serum or plasma on ELITech Vital
Scientific Selectra/Flexor analyzers. It
is not intended for use in Point of Care
settings. | For in vitro diagnostic use in the quan-
titative determination of cholesterol in
serum or plasma. |
| Indication for Use | Cholesterol measurements are used
in the diagnosis and treatment of dis-
orders involving excess cholesterol in
the blood and lipid and lipoprotein
metabolism disorders. | Cholesterol measurements are used
in the diagnosis and treatment of dis-
orders involving excess cholesterol in
the blood and lipid and lipoprotein
metabolism disorders. |
| Assay protocol | Enzymatic colorimetric method using
cholesterol esterase/ cholesterol
oxidase coupled with
peroxidase
(Trinder method). | Enzymatic colorimetric method using
cholesterol esterase/ cholesterol oxi-
dase coupled with peroxidase (Trinder
method). |
| Composition | Reagent:
Pipes buffer 50 mmol/L;
Phenol 24 mmol/L;
Sodium cholate 5 mmol/L;
4-Aminoantipyrine 0.5 mmol/L;
Cholesterol esterase ≥ 180 U/L;
Cholesterol oxidase ≥ 200 U/L;
Peroxidase ≥ 1 000 U/L;
Sodium azide 240 mg/dL |
| | ELITech Clinical Systems Device
CHOLESTEROL SL | Predicate device
(ABX PENTRA CHOLESTEROL CP) |
| Instrument | Vital Scientific SELECTRA JUNIOR | ABX PENTRA 400 |
| Measuring range | 20 to 600 mg/dL | 2.55 to 580 mg/dL |
| Precision | Within run
Level 116 mg/dL CV=2.4%
Level 190 mg/dL CV=1.9%
Level 298 mg/dL CV=1.7%
Total
Level 116 mg/dL CV=2.6%
Level 190 mg/dL CV=2.7%
Level 298 mg/dL CV=2.7% | Within run
Level 113 mg/dL CV=0.82%
Level 186 mg/dL CV=0.74%
Level 117 mg/dL CV=1.21%
Level 191 mg/dL CV=0.53%
Level 389 mg/dL CV=0.62%
Total
Level 109 mg/dL CV=2.96%
Level 183 mg/dL CV=2.34%
Level 170 mg/dL CV=2.80%
Level 250 mg/dL CV=3.01% |
| Method comparison | y=1.006 x - 1.734 mg/dL
$r^2$ = 0.999
range: 20 to 579 mg/dL | y=0.95x + 1.90 mg/dL
$r^2$ = 0.9943
range: 2.55 to 583.26 mg/dL |
| Cholesterol Reference
Laboratory Network
(CRMLN) certification | Certified | Certified |
| Limitations | Unconjugated bilirubin: No significant interference up to 6.0 mg/dL.
Conjugated bilirubin: No significant interference up to 5.9 mg/dL.
Hemoglobin: No significant interference up to 250 mg/dL.
Turbidity: No significant interference up to 614 mg/dL triglyceride equivalent.
Ascorbic acid: No significant interference up to 2.0 mg/dL. Concentrations above the therapeutic levels will interfere and cause erroneous results.
Methyl-dopa: No significant interference up to 0.8 mg/dL. Concentrations above the therapeutic levels will interfere and cause erroneous results.
Uric acid: No significant interference up to 23.4 mg/dL. | Hemoglobin: No significant influence is observed up to 336 mg/dL.
Total bilirubin: No significant influence is observed up to 20.5 mg/dL.
Direct bilirubin: No significant influence is observed up to 6.8 mg/dL.
Triglycerides: No significant influence is observed up to 612.5 mg/dL |
| Calibration Frequency | 28 days | 8 days |
| On board stability | refrigerated area : 28 days | refrigerated area: 48 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 name
| 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 ac- | |
| cording to FDA-approved methods or methods in compliance with the Euro- | |
| pean Directive 98/79/EC, Annex II, List A. | |
| Intended Use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro |
| diagnostic use in the calibration of quantitative ELITech Clinical Systems me- | |
| thods on the ELITech Vital Scientific Selectra/Flexor Analyzers. |
| | ELITech Clinical Systems Device
(ELICAL 2) | Predicate device
(Roche Calibrator f.a.s.) |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Vital Scientific Selectra/Flexor 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 lyophilate, 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 lyophilate, 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. |
6
| | ELITech Clinical Systems Device
(ELICAL 2) | Predicate device
(Roche Calibrator f.a.s.) |
|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Lyophilized:
To store at 2-8°C and protected
from light until the expiry date | Lyophilized:
Stable at 2-8°C up to expiration
date. |
| | After reconstitution, the stabilities
are :
- 8 hours between 15-25 °C.
- 2 days between 2-8 °C.
- 4 weeks between -25 and -15 °C
(when frozen once) | After reconstitution, the stabilities*
are : - 8 hours at 15-25 °C.
- 2 days at 2-8 °C.
- 4 weeks at (-25)-(-15) °C (when
frozen once) |
| | | *Exception for bilirubin total & direct
as noted in package insert |
Device names
| CONTROLS: | |
|---|---|
| Trade/proprietary Name: | ELITech Clinical Systems ELITROL I and ELITROL II |
| Common or Usual Name: | Multi-analyte controls – all kinds, "ELITROL I"- "ELITROL II" |
| Device Class | Class I |
| Classification name | Quality control material (assayed and unassayed). (21 CFR |
| 862.1660) | |
| Product code | 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 constitu- | |
| ents 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 multiparametric |
| control sera for use in quality control of ELITech Clinical Systems methods | |
| on ELITech Vital Scientific Selectra/Flexor Analyzers. |
| | ELITech Clinical Systems Device
ELITROL I / ELITROL II | Predicate Device
Roche Precinorm U / Precipath U |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems ELITROL
I & ELITROL II are multiparametric
control sera for use in quality con-
trol of ELITech Clinical Systems
methods on ELITech Vital Scientific | For in vitro diagnostic use in quality
control by monitoring accuracy and
precision for the quantitative meth-
ods as specified in the value sheet |
7
| Selectra/Flexor Analyzers. | ||
|---|---|---|
| Format | Lyophilized human sera with con- | |
| stituents added as required to ob- | ||
| tain desired components levels | Lyophilized human sera with con- | |
| stituents added as required to ob- | ||
| tain desired components levels | ||
| Levels | Two levels | Two levels |
| Handling | Carefully open the vial, avoiding the | |
| loss of lyophilate, 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. | Carefully open the bottle, avoiding | |
| the loss of lyophilate, and pipette in | ||
| exactly 5 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. | ||
| Stability | Lyophilized: | |
| To store at 2-8°C and protected | ||
| from light until the expiry date |
After reconstitution, the stabilities
are:
- 12 hours between 15-25 °C.
- 5 days between 2-8 °C.
- 4 weeks between -25 and -15 °C
(when frozen once) | Lyophilized:
Stable at 2-8°C up to expiration
date.
After reconstitution, the stabilities*
are:
- 12 hours at 15-25 °C.
- 5 days at 2-8 °C.
- 4 weeks at (-25)-(-15) °C (when
frozen once)
*Exception for bilirubin total & direct
as noted in package insert |
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of these devices versus their respective predicate devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices.
8
Image /page/8/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle or bird-like symbol on the right side. To the left of the bird, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 19 2011
SEPPIM S.A.S. Elitech Group Epoch Biosciences c/o Ms. Debra Hutson Director. Ouality Assurance/Regulatory Affairs 21720 23rd Drive, S.E., Suite 150 Bothell, Washington 98021
Re: K102993
Trade Name: ELITech Clinical Systems Cholesterol SL, ELITech Clinical Systems Triglycerides SL, ELITech Clinical Systems Elical 2, ELITech Clinical Systems Elitrol I and II
Regulation Number: 21 CFR $862.1175
Regulation Name: Cholesterol Test System.
Regulatory Class: Class I, meets the limitations to exemptions 21 CFR 862.9 (c)(4)
Product Codes: CHH, CDT, JIX, JJY
Dated: April 29, 2011
Received: May 03, 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 Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _K102993 _________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
ELITech Clinical Systems TRIGLYCERIDES SL is intended for the quantitative in vitro diagnostic determination of triglycerides in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings
Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
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)
ATT
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102993
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510(k) Number (if known): K102993
Device Name:
Indications for Use:
ELITech Clinical Systems CHOLESTEROL SL is intended for the quantitative in vitro diagnostic determination of cholesterol in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102993
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510(k) Number (if known): K102993
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use: .
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the ELITech Vital Scientific Selectra/Flexor Analyzers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kr02993
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510(k) Number (if known): __ K 102993
Device Name:
Indications for Use:
ELITech Clinical Systems ELITROL I & ELITROL II are multiparametric control sera for use in quality control of ELITech Clinical Systems methods on ELITech Vital Scientific Selectra/Flexor Analyzers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102993
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