(463 days)
Not Found
No
The document describes chemical reagents and calibrators for in vitro diagnostic tests, which are standard laboratory consumables and do not inherently incorporate AI/ML technology. There is no mention of AI, ML, or related concepts in the text.
No
The device is described as an "in vitro diagnostic" reagent used for quantitative determination of substances like phosphorus, uric acid, and urea in human serum and plasma. Its purpose is for diagnosis and treatment of various disorders, not for direct therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the reagents (PHOSPHORUS, URIC ACID MONO SL, and UREA UV SL) are for "in vitro diagnostic determination" and that their measurements "are used in the diagnosis and treatment of various disorders." The calibrator (ELICAL 2) and control serums (ELITROL I and ELITROL II) are also specified for "in vitro diagnostic use."
No
The device description explicitly states that the devices are reagents and calibrators, which are physical substances used in laboratory testing, not software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section for each reagent and the calibrator/controls explicitly states that they are "for the quantitative in vitro diagnostic determination" or "for in vitro diagnostic use".
- Purpose of the Device: The reagents are designed to measure specific substances (inorganic phosphorus, uric acid, urea nitrogen) in human biological samples (serum and plasma) to aid in the diagnosis and treatment of various medical conditions. This is the core function of an IVD.
- Calibrators and Controls: The inclusion of calibrators (ELICAL 2) and controls (ELITROL I and ELITROL II) further confirms the IVD nature of the system, as these are essential components for ensuring the accuracy and reliability of in vitro diagnostic tests.
N/A
Intended Use / 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 Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems UREA UV SL is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitative in vitro diagnostic determination of urea nitrogen in human serum and plasma. It is not intended for use in Point of Care settings. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
ELITech Clinical Systems PHOSPHORUS is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitative in vitro diagnostic determination of inorganic phosphorus in human serum and plasma. It is not intended for use in Point of Care settings. (Inorganic) phosphorus measurements are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
ELITech Clinical Systems URIC ACID MONO SL is intended for use with ELITech Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitative in vitro diagnostic determination of uric acid in human serum and plasma. It is not intended for use in Point of Care settings. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
Product codes (comma separated list FDA assigned to the subject device)
CDQ, KNK, CEO, JIX, JJY
Device Description
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 UREA UV SL: The device for this submission is available as kit only. It consists of 2 reagents: Reagent 1 contains Tris buffer (pH 7.60), Adenosine diphosphate potassium salt (ADP), α-Ketoglutarate, Urease (jack bean), Glutamate dehydrogenase (GIDH) (bovine liver) and sodium azide. Reagent 2 contains NADH and sodium azide.
ELITech Clinical Systems PHOSPHORUS: The device for this submission is available as kit only. It consists of 1 reagent R. Reagent R consists of sulfuric acid and ammonium molybdate.
ELITech Clinical Systems URIC ACID MONO SL: The device for this submission is available as kit only. It consists of 1 reagent R. Reagent R consists of Phosphate buffer (pH 7.0), N-Ethyl-N-(2-Hydroxy-3-Sulfopropyl) m-Toluidine (EHSPT), Ferrocyanide, Amino-4-antipyrine (4-AAP), Uricase (microorganisms), Peroxidase (horseradich) and sodium azide.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data provided for Urea UV SL, Phosphorus, and Uric Acid Mono SL include:
- Measuring range:
- Urea UV SL: 4.7 to 140.0 mg/dL; Extended: 140.0 to 670.0 mg/dL
- Phosphorus: 2.0 to 20.0 mg/dL
- Uric Acid Mono SL: 1.5 to 25.0 mg/dL; Extended: 25 to 78 mg/dL
- Limit of detection (LoD):
- Urea UV SL: 0.3 mg/dL
- Phosphorus: 0.02 mg/dL
- Uric Acid Mono SL: 0.02 mg/dL
- Limit of quantification (LoQ):
- Urea UV SL: 2.3 mg/dL
- Phosphorus: 1.00 mg/dL
- Uric Acid Mono SL: 0.50 mg/dL
- Precision:
- Urea UV SL (Within run): Level 7.3 mg/dL CV=2.1%; Level 29.2 mg/dL CV=0.8%; Level 72.4 mg/dL CV=0.7%
- Urea UV SL (Total): Level 7.3 mg/dL CV=2.8%; Level 29.2 mg/dL CV=1.3%; Level 72.4 mg/dL CV=1.6%
- Phosphorus (Within run): Level 2.37 mg/dL CV=1.1%; Level 4.80 mg/dL CV=1.5%; Level 9.55 mg/dL CV=1.7%
- Phosphorus (Total): Level 2.37 mg/dL CV=1.9%; Level 4.80 mg/dL CV=1.7%; Level 9.55 mg/dL CV=2.2%
- Uric Acid Mono SL (Within run): Level 2.49 mg/dL CV=0.8%; Level 5.19 mg/dL CV=1.3%; Level 7.63 mg/dL CV=1.1%
- Uric Acid Mono SL (Total): Level 2.49 mg/dL CV=2.6%; Level 5.19 mg/dL CV=2.0%; Level 7.63 mg/dL CV=2.1%
- Method comparison:
- Urea UV SL: y=0.991 x + 0.6 mg/dL; r= 0.999; range: 4.4 to 139.8 mg/dL
- Phosphorus: y=0.999 - 0.09 mg/dL; r= 0.999; range: 2.02 to 20.08 mg/dL
- Uric Acid Mono SL: y=1.015 x + 0.03 mg/dL; r= 0.999; range: 1.49 to 24.40 mg/dL
- Limitations (Interferences):
- Urea UV SL: Hemoglobin (up to 500 mg/dL), Turbidity (up to 614 mg/dL triglyceride equivalent), Unconjugated bilirubin (up to 30 mg/dL), Conjugated bilirubin (up to 29.5 mg/dL), Ascorbic acid (up to 20 mg/dL), Methyldopa (up to 1 mg/dL)
- Phosphorus: Hemoglobin (up to 50 mg/dL), Unconjugated bilirubin (up to 15 mg/dL), Conjugated bilirubin (up to 1.5 mg/dL), Glucose (up to 500 mg/dL), Triglycerides (up to 732 mg/dL)
- Uric Acid Mono SL: Hemoglobin (up to 50 mg/dL), Unconjugated bilirubin (up to 30 mg/dL), Conjugated bilirubin (up to 14.8 mg/dL), Glucose (up to 500 mg/dL), Ascorbic acid (significant interference), Triglycerides (up to 1070 mg/dL), Methyldopa (up to 1 mg/dL), Calcium dobesilate (induces falsely low results).
Conclusion for all devices: The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is 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.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K033501, K060205, K070146, K060205, K070249, K060205, K081276, K041227
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(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 the limitations in § 862.9.
0
SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELICAL 2 MAY - 6 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 substantial equivalence. | | ELITech Clinical Systems Device
(ELICAL 2) | Predicate device
(Roche Calibrator f.a.s.) |
|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The assigned 510(k) number is: K100263 | 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
Vital Scientific Selectra Junior
Analyzer and the Vital Scientific
Flexor Junior Analyzer. | For in vitro diagnostic use in the
calibration of quantitative Roche
methods on Roche clinical
chemistry analysers as specified in
the value sheets. |
| 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 | 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 |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Level | Single level | Single level |
| Date of Preparation | Friday, January 22nd 2010 | 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. |
| Trade/proprietary Name:
Common or Usual Name:
Device Class
Classification name
Product code | ELITech Clinical Systems ELICAL 2
Calibrator, multi-analyte mixture, "ELICAL 2"
Class II
Calibrator (21 CFR 862.1150)
JIX- Calibrator, multi-analyte mixture | 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. |
| Predicate device | Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)
(K033501) | 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. |
| 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. | | 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) |
| 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 Vital Scientific Selectra Junior Analyzer and the Vital Scientific
Flexor Junior Analyzer. | | | *Exception for bilirubin total & direct
as noted in package insert |
1
Comparison to Predicate device
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
2
SECTION 5 - 510(k) Summary ELITech Clinical Systems UREA UV SL reagent
| 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. | | ELITech Clinical Systems Device
UREA UV SL | Predicate device
(ABX PENTRA UREA CP) |
|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The assigned 510(k) number is: K100263 | Intended Use | Intended for use with ELITech
Clinical Systems ELICAL 2 and
ELITech Clinical Systems ELITROL I
and ELITROL II on Vital Scientific
Selectra/Flexor analyzers for the
quantitative in vitro diagnostic
determination of urea nitrogen in
human serum and plasma.
It is not intended for use in Point of
Care settings. | For in vitro diagnostic use in the
quantitative determination of
urea/urea nitrogen in serum, plasma
and urine. |
| 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 | Indication(s) for Use | Intended to measure urea nitrogen
in human serum and plasma. Urea
nitrogen measurements are used in
the diagnosis and treatment of
certain renal and metabolic
diseases. | Urea nitrogen measurements are
used in the diagnosis and treatment
of certain renal and metabolic
diseases. |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Assay protocol | Enzymatic UV method using Urease
and Glutamate dehydrogenase | Enzymatic UV method using Urease
and Glutamate dehydrogenase |
| Date of Preparation | Friday, January 22nd 2010 | Composition | Reagent R1:
Tris buffer, pH 7.60 125 mmol/L;
ADP 1 mmol/L;
α-Ketoglutarate 9 mmol/L;
Urease ≥ 8 100 U/L;
GIDH ≥ 1 350 U/L;
Sodium azide Urea nitrogen (BUN)
Adults (21-60 years) 6-20 mg/dL
Adults (60-90 years) 8-23 mg/dL
Adults (> 90 years) 10-31 mg/dL | Serum, plasma:
Urea nitrogen (BUN)
Adults:
Global : 7.9-20.2 mg/dL
Women 50 years 9.8-20.2 mg/dL
Men 50 years 8.4-25.8 mg/dL
Children:
1-3 years 5.1-16.8 mg/dL |
| Intended Use | ELITech Clinical Systems UREA UV SL is intended for use with ELITech Clinical
Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and ELITROL II on
Vital Scientific Selectra/Flexor analyzers for the quantitative in vitro diagnostic
determination of urea nitrogen in human serum and plasma.
It is not intended for use in Point of Care settings. | | | |
| Indication(s) for Use | ELITech Clinical Systems UREA UV SL is intended to measure urea nitrogen in
human serum and plasma. Urea nitrogen measurements are used in the
diagnosis and treatment of certain renal and metabolic diseases. | | | |
3
Comparison to Predicate device
4
| | ELITech Clinical Systems Device
UREA UV SL | Predicate device
(ABX PENTRA UREA CP) |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | 14-19 years
8.1-21.1 mg/dL |
| Instrument | SELECTRA JUNIOR | ABX PENTRA 400 |
| Measuring range* | 4.7 to 140.0 mg/dL
Extended measuring range : 140.0 to 670.0 mg/dL | 1.03 to 140.3 mg/dL
Automatic post-dilution: 701.5 mg/dL |
| Limit of detection (LoD)* | 0.3 mg/dL | |
| Limit of quantification (LoQ)* | 2.3 mg/dL | 0.9 mg/dL |
| Precision* | Within run
Level 7.3 mg/dL CV=2.1%
Level 29.2 mg/dL CV=0.8%
Level 72.4 mg/dL CV=0.7%
Total
Level 7.3 mg/dL CV=2.8%
Level 29.2 mg/dL CV=1.3%
Level 72.4 mg/dL CV=1.6% | Within run
Level 18.7 mg/dL CV=2.27%
Level 72.8 mg/dL CV=1.66%
Level 6.0 mg/dL CV=2.76%
Level 20.9 mg/dL CV=1.58%
Level 85.5 mg/dL CV=1.80%
Total
Level 18.5 mg/dL CV=2.14%
Level 71.7 mg/dL CV=1.93%
Level 19.2 mg/dL CV=2.14%
Level 70.1 mg/dL CV=1.97% |
| Method comparison* | y=0.991 x + 0.6 mg/dL
r= 0.999
range: 4.4 to 139.8 mg/dL | y=0.99 x - 0.06 mg/dL
r²= 0.996
range: 1.03 to 138.89 mg/dL |
| Limitations | Hemoglobin: No significant interference up to 500 mg/dL.
Turbidity: No significant interference up to 614 mg/dL triglyceride equivalent.
Unconjugated bilirubin: No significant interference up to 30 mg/dL.
Conjugated bilirubin: No significant interference up to 29.5 mg/dL.
Ascorbic acid: No significant interference up to 20 mg/dL.
Methyldopa: No significant interference up to 1 mg/dL. | Hemoglobin: No significant influence is observed up to 460 mg/dL.
Triglycerides: No significant influence is observed up to 612.5 mg/dL.
Total bilirubin: No significant influence is observed up to 22.23 mg/dL.
Direct bilirubin: No significant influence is observed up to 23.40 mg/dL. |
| Calibration Frequency | 7 days | 8 days |
| On board stability | refrigerated area : 14 days | refrigerated area: 70 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 | Recommended quality control material (not included):
ABX Pentra N Control |
| ELITech Clinical Systems Device
UREA UV SL | Predicate device:
(ABX PENTRA UREA CP) | |
| (Normal control) | (Normal control) | |
| ELITech Clinical Systems Elitrol II
(Pathologic control) | ABX Pentra P Control (Pathologic
control) | |
5
- : values expressed in BUN
The performance data and other information demonstrate that the safety and Conclusion effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
6
SECTION 5 - 510(k) Summary ELITech Clinical Systems PHOSPHORUS reagent
| | | | ELITech Clinical Systems Device
PHOSPHORUS | Predicate device
(ABX PENTRA PHOSPHORUS CP) |
|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Intended use | Intended for use with ELITech
Clinical Systems ELICAL 2 and
ELITech Clinical Systems ELITROL I
and ELITROL II on Vital Scientific
Selectra/Flexor analyzers for the
quantitative in vitro diagnostic
determination of inorganic
phosphorus in human serum and
plasma. It is not intended for use in
Point of Care settings. | For in vitro diagnostic use in the
quantitative determination of
phosphorus in serum, plasma and
urine. |
| | The assigned 510(k) number is: K100263 | Indication for Use | Intended to measure inorganic
phosphorus in human serum and
plasma. (Inorganic) phosphorus
measurements are used in the
diagnosis and treatment of various
disorders, including parathyroid
gland and kidney diseases, and
vitamin D imbalance. | Measurements of phosphorus
(inorganic) are used in the diagnosis
and treatment of various disorders,
including parathyroid gland and
kidney diseases, and vitamin D
imbalance. |
| 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 | Assay protocol | UV method using
phosphomolybdate | UV method using
phosphomolybdate |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Composition | Reagent R:
Sulfuric acid 210 mmol/L;
Ammonium molybdate 650 µmol/L : | Reagent:
Sulfuric acid 210 mmol/L;
Ammonium molybdate 650 µmol/L; |
| Date of Preparation | Friday, January 22nd 2010 | Appearance of reagent | Liquid form, ready to use | Liquid form, ready to use |
| Device names | | Sample type | Serum
Plasma in lithium heparin | Serum
Plasma in lithium heparin
Urine |
| REAGENT :
Trade/proprietary Name:
Common or Usual Name:
Device Class
Classification name
Product code | ELITech Clinical Systems PHOSPHORUS
Inorganic phosphorus, "PHOSPHORUS"
Class I
Phosphorus (inorganic) test system (Sec.862.1580)
CEO - Phosphomolybdate (colorimetric), inorganic phosphorus | Reagent storage | Store at 2-25 °C and protected 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 °С. |
| Predicate device | ABX PENTRA PHOSPHORUS CP (K060205, K070249) | Expected values | Serum, plasma : 2.7 - 4.5 mg/dL | Serum, plasma : 2.7 - 4.5 mg/dL |
| Device description | The device for this submission is available as kit only. It consists of 1 reagent R.
Reagent R consists of sulfuric acid and ammonium molybdate. | Instrument | SELECTRA JUNIOR | ABX PENTRA 400 |
| Intended Use | ELITech Clinical Systems PHOSPHORUS is intended for use with ELITech
Clinical Systems ELICAL 2 and ELITech Clinical Systems ELITROL I and
ELITROL II on Vital Scientific Selectra/Flexor analyzers for the quantitative in
vitro diagnostic determination of inorganic phosphorus in human serum and
plasma. It is not intended for use in Point of Care settings. | Measuring range | 2.0 to 20.0 mg/dL | 0.30 to 24.18 mg/dL
Automatic post-dilution: 96.72 mg/dL |
| Indication(s) for Use | ELITech Clinical Systems PHOSPHORUS is intended to measure inorganic
phosphorus in human serum and plasma. (Inorganic) phosphorus
measurements are used in the diagnosis and treatment of various disorders,
including parathyroid gland and kidney diseases, and vitamin D imbalance. | Limit of detection (LoD) | 0.02 mg/dL | 0.28 mg/dL |
| Limit of quantification (LoQ) | 1.00 mg/dL | | | |
| Precision | Within run
Level 2.37 mg/dL CV=1.1%
Level 4.80 mg/dL CV=1.5%
Level 9.55 mg/dL CV=1.7% | Within run
Level 4.08 mg/dL CV=1.25%
Level 6.34 mg/dL CV=0.77%
Level 2.39 mg/dL CV=2.48%
Level 3.48 mg/dL CV=1.61%
Level 9.19 mg/dL CV=1.38% | | |
7
Comparison to Predicate device
8
| | ELITech Clinical Systems Device
PHOSPHORUS | Predicate device
(ABX PENTRA PHOSPHORUS CP) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Total | Level 2.37 mg/dL CV=1.9%
Level 4.80 mg/dL CV=1.7%
Level 9.55 mg/dL CV=2.2% | Total
Level 4.01 mg/dL CV=2.50%
Level 6.35 mg/dL CV=1.82%
Level 2.50 mg/dL CV=3.56%
Level 11.44 mg/dL CV=1.38% |
| Method comparison | y=0.999 - 0.09 mg/dL
r= 0.999
range: 2.02 to 20.08 mg/dL | y=1.04x + 0.15 mg/dL
r2= 0.998
range: 0.30 to 24.08 mg/dL |
| Limitations | Hemoglobin: No significant
interference is observed up to 50
mg/dL. Unconjugated bilirubin: No
significant interference is observed
up to 15 mg/dL
Conjugated bilirubin: No significant
interference is observed up to 1.5
mg/dL.
Glucose: No significant interference
is observed up to 500 mg/dL.
Triglycerides: No significant
interference is observed up to 732
mg/dL. | Hemoglobin: No significant
influence is observed up to 125
mg/dL.
Triglycerides: No significant
influence is observed up to 262.5
mg/dL.
Total bilirubin: No significant
influence is observed up to 6 mg/dL.
Direct bilirubin: No significant
influence is observed up to 25
mg/dL. |
| Calibration Frequency | 28 days | 34 days |
| On board stability | refrigerated area : 28 days | refrigerated area: 70 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) |
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
9
SECTION 5 - 510(k) Summary ELITech Clinical Systems URIC ACID MONO SL reagent
| | | | ELITech Clinical Systems Device.
URIC ACID MONO SL | Predicate device :
(ABX PENTRA URIC ACID CP) | |
|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| 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. | | Intended use | Intended for use with ELITech
Clinical Systems ELICAL 2 and
ELITech Clinical Systems ELITROL I
and ELITROL II on Vital Scientific
Selectra/Flexor analyzers for the
quantitative in vitro diagnostic
determination of uric acid in human
serum and plasma.
It is not intended for use in Point of
Care settings. | For in vitro diagnostic use in the
quantitative determination of uric
acid in serum, plasma and urine. |
| | The assigned 510(k) number is: K100263 | Indication(s) for Use | Intended to measure uric acid in
human serum and plasma. Uric acid
measurements are used in the
diagnosis and treatment of
numerous renal and metabolic
disorders, including renal failure,
gout, leukemia, psoriasis, starvation
or other wasting conditions, and of
patients receiving cytotoxic drugs. | Uric acid measurements are used in the
diagnosis and treatment of
numerous renal and metabolic
disorders, including renal failure,
gout, leukemia, psoriasis, starvation
or other wasting conditions, and of
patients receiving cytotoxic drugs. | |
| 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 | Assay protocol | Enzymatic determination using a
chromgenic system in the presence
of peroxidase and uricase (Trinder
method). | Enzymatic determination using a
chromgenic system in the presence
of peroxidase and uricase (Trinder
method). | |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Composition | Reagent R:
Phosphate buffer; pH 7.0 $100 mmol/L$ ;
EHSPT $0.72 mmol/L$ ;
Ferrocyanide $0.03 mmol/L$ ;
Amino-4-antipyrine $0.37 mmol/L$ ;
Uricase $\geq 150 U/L$ ;
Peroxidase $\geq 12 000 U/L$ ;
Sodium azide $in vitro diagnostic determination of uric acid in human serum and plasma.
It is not intended for use in Point of Care settings. | | | | |
| Indication(s) for Use | ELITech Clinical Systems URIC ACID MONO SL is intended to measure uric
acid in human serum and plasma. Uric acid measurements are used in the
diagnosis and treatment of numerous renal and metabolic disorders, including
renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions,
and of patients receiving cytotoxic drugs. | | | | |
10
Comparison to Predicate device
11
| | ELITech Clinical Systems Device
URIC ACID MONO SL | Predicate device
(ABX PENTRA URIC ACID CP) |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Instrument | SELECTRA JUNIOR | ABX PENTRA 400 |
| Measuring range | 1.5 to 25.0 mg/dL
Extended measuring range : 25 to 78 mg/dL | 0.18 to 25.00 mg/dL
Automatic post-dilution: 75.00 mg/dL |
| Limit of detection (LoD) | 0.02 mg/dL | 0.19 mg/dL |
| Limit of quantification (LoQ) | 0.50 mg/dL | |
| Precision | Within run
Level 2.49 mg/dL CV=0.8%
Level 5.19 mg/dL CV=1.3%
Level 7.63 mg/dL CV=1.1%
Total
Level 2.49 mg/dL CV=2.6%
Level 5.19 mg/dL CV=2.0%
Level 7.63 mg/dL CV=2.1% | Within run
Level 4.62 mg/dL CV=0.45%
Level 11.63 mg/dLCV=0.34%
Level 2.53 mg/dL CV=1.24%
Level 4.58 mg/dL CV=0.91%
Level 7.19 mg/dL CV=1.02%
Total
Level 4.64 mg/dL CV=2.81%
Level 11.73 mg/dLCV=1.39%
Level 4.67 mg/dL CV=2.64%
Level 6.74 mg/dL CV=2.51% |
| Method comparison | y=1.015 x + 0.03 mg/dL
r= 0.999
range: 1.49 to 24.40 mg/dL | y=0.95 x + 0.09 mg/dL
r2= 0.996
range: 0.18 to 23.59 mg/dL |
| Limitations | Hemoglobin: No significant
interference up to 50 mg/dL.
Unconjugated bilirubin: No
significant interference up to 30
mg/dL
Conjugated bilirubin: No
significant interference up to 14.8
mg/dL.
Glucose: No significant interference
up to 500 mg/dL.
Ascorbic acid: Significant
interference on samples containing
ascorbic acid.
Triglycerides:. No significant
interference up to 1070 mg/dL.
Methyldopa: No significant
interference up to 1 mg/dL.
Calcium dobesilate: Induces falsely
low results on individuals taking
calcium dobesilate. | Hemoglobin: No significant
influence is observed up to 500
mg/dL.
Triglycerides: No significant
influence is observed up to 612.5
mg/dL.
Total bilirubin: No significant
influence is observed up to 36
mg/dL.
Direct bilirubin: No significant
influence is observed up to 30
mg/dL. |
| Calibration Frequency | 28 days | 15 days |
| | ELITech Clinical Systems Device
URIC ACID MONO SL | Predicate device
(ABX PENTRA URIC ACID CP) |
| On board stability | refrigerated area : 28 days | refrigerated area: 41 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) |
.
12
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
13
SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELITROL I and ELITROL II
| 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: K100263 | |
| 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 | Friday, January 22nd 2010 | |
| 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)
JJX- 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 is a multi-parametric control serum for in
vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems
methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific
Flexor Junior Analyzer. | |
14
ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
Comparison to Predicate device
| | ELITech Clinical Systems Device
ELITROL I / ELITROL II | Predicate Device
Roche Precinorm U / Precipath U | |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended use | ELITech Clinical Systems ELITROL I is a
multi-parametric control serum for in vitro
diagnostic use in accuracy control of
quantitative ELITech Clinical Systems
methods on the Vital Scientific Selectra
Junior Analyzer and the Vital Scientific
Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL II is
a multi-parametric control serum for in vitro diagnostic use in accuracy control
of quantitative ELITech Clinical Systems
methods on the Vital Scientific Selectra
Junior Analyzer and the Vital Scientific
Flexor Junior Analyzer. | For in vitro diagnostic use in quality
control by monitoring accuracy and
precision for the quantitative methods
as specified in the value sheet. | |
| 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 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 the predicate devices are not | | |
ess 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.
15
Public Health Service
Image /page/15/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
ELITech Group Epoch Biosciences c/o Debra Hutson 21720 23rd Dr., SE, Suite 150 Bothell. WA 98021
Re: K100263
Trade/Device Name: ELITech Clinical Systems Urea UV SL Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDQ, KNK, CEO, JIX, JJY Dated: 30 March 2011 MAY -6 2011 Received: 04 April 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 class II (Special Controls), 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
16
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification'' (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
Courtney C. 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
17
Image /page/17/Picture/0 description: The image is a simple black and white image with a few small, dark spots scattered across the white background. The spots are irregularly shaped and vary slightly in size. The overall impression is one of sparseness and simplicity, with the dark spots providing a minimal contrast against the bright white backdrop.
510(k) Number (if known): K100263
Device Name:
Indications for Use:
ELITech Clinical Systems PHOSPHORUS reagent is for the quantitative in vitro diagnostic determination of inorganic phosphorus in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers.
It is not intended for use in Point of Care settings.
Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
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)
RA
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100263
Page 1 of J
18
510(k) Number (if known): K100263
Device Name:
Indications for Use:
ELITech Clinical Systems URIC ACID MONO SL reagent is for the quantitative in vitro diagnostic determination of uric acid in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers.
It is not intended for use in Point of Care settings.
Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
X Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________
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) K100263
Page 2 of J
ﺮ ﺍ
19
510(k) Number (if known): K100263
Device Name:
Indications for Use:
!
ELITech Clinical Systems UREA UV SL reagent is for the quantitative in vitro diagnostic determination of urea nitrogen in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers.
It is not intended for use in Point of Care settings.
Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
x Prescription Use (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) K100263
Page of J
20
510(k) Number (if known): K100263
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 the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
Prescription Use >