(155 days)
No
The summary describes a chemical assay kit and associated calibrators and controls for measuring creatinine. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) test for quantitative determination of creatinine. It aids in diagnosis and treatment but does not directly deliver therapy or treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the quantitative in vitro diagnostic determination of creatinine," and that "Creatinine measurements are used in the diagnosis and treatment of renal diseases." This clearly indicates its role in diagnosis.
No
The device description clearly states it consists of a "bi-reagent R1 and R2" and other physical components like lyophilized calibrators and liquid control solutions. These are physical reagents and controls, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the ELITech Clinical Systems CREATININE PAP SL is "intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine". It also mentions that the calibrator and control materials are for "in vitro diagnostic use".
- Device Description: The description details the reagents, calibrator, and control materials used for testing biological samples (serum, plasma, urine) outside of the body.
- Intended User/Care Setting: While it specifies "Prescription Use Only" and "not intended for use in Point of Care settings", this still aligns with the use of IVDs in clinical laboratory settings.
- Performance Studies: The document includes performance studies like precision, linearity, detection limit, interference, and method comparison, which are standard evaluations for IVD devices.
- Predicate Device(s): The inclusion of predicate devices with K numbers indicates that this device is being compared to previously cleared IVD devices.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine on ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
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 Pro Series Analyzers.
ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
Product codes
JFY, JIX, JJY
Device Description
ELITech Clinical Systems CREATININE PAP SL is available as kit only. It consists of a bi-reagent R1 and R2 whose composition is, for R1: MOPS buffer (pH 7.50), EHSPT, Creatinase, Sarcosine oxidase, Ascorbate oxidase. For R2: MOPS buffer (pH 7.50), 4-Aminoantipyrine, Creatininase, Peroxidase, sodium azide.
ELITech Clinical Systems ELICAL2 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 the antibodies to HCV and HIV according to FDA-approved methods.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of a 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.
ELITech Clinical Systems URINE CONTROL BI-LEVEL is a liquid solution prepared from human urine supplemented with constituents of human and animal origin, chemicals, preservatives and stabilizers. Human sera corresponding to the URINE CONTROL BI-LEVEL were tested for each urine donor and found to be negative for HbsAg and antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods.
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
Prescription Use Only. It is not intended for use in Point of Care settings.
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
a. Precision/Reproducibility:
Study type: Precision/Reproducibility study according to CLSI (NCCLS) document EP05-A2.
Sample size: 80 for each level (3 levels for serum/plasma, 3 levels for urine).
Key results: Serum/Plasma: Level 1 (0.76 mg/dL) - Within-run CV% 1.2%, Total CV% 1.9%; Level 2 (1.52 mg/dL) - Within-run CV% 0.6%, Total CV% 1.7%; Level 3 (5.52 mg/dL) - Within-run CV% 0.5%, Total CV% 1.5%. Urine: Level 1 (83 mg/dL) - Within-run CV% 0.8%, Total CV% 2.2%; Level 2 (159 mg/dL) - Within-run CV% 0.7%, Total CV% 2.3%; Level 3 (308 mg/dL) - Within-run CV% 1.9%, Total CV% 2.9%.
b. Linearity/assay reportable range:
Study type: Linearity study according to CLSI protocol EP06-A.
Measuring range: Serum/Plasma: 0.10 to 30 mg/dL (up to 150 mg/dL with manual dilution 1 to 5). Urine: 5 to 450 mg/dL.
c. Traceability:
Value is traceable to the ID-MS (Isotope Dilution -Mass Spectrometry) reference method.
d. Stability:
On board stability for reagent: 28 days.
Shelf-life of reagent: 20 months (real-time studies on 3 different batches).
Shelf-life of ELITROL I and ELITROL II (lyophilized): 24 months at 2-8°C.
Stability of ELITROL I and ELITROL II (reconstituted): 12 hours at 15-25℃, 5 days at 2-8°C, or 4 weeks (frozen once) at -25° and -15° C.
Shelf-life of ELICAL 2 (lyophilized): 24 months at 2-8°C.
Stability of ELICAL 2 (reconstituted): 8 hours at 15-25°C, 2 days at 2-8°C, or 4 weeks (frozen once) at -25°and -15°C.
ELITech Clinical Systems URINE CONTROL BI-LEVEL stability: 10 months at 2-8°C. After opening, 30 days when stored tightly closed at 2-8°C.
e. Detection limit:
Study type: Determined according to CLSI protocol EP17-A.
Serum/Plasma: Limit of Detection (LoD) is 0.02 mg/dL, Limit of Quantification (LoQ) is 0.08 mg/dL.
Urine: Limit of Detection (LoD) is 0.5 mg/dL, Limit of Quantification (LoQ) is 2.0 mg/dL.
f. Interference/analytical specificity:
Interference testing according to CLSI EP07-A2 protocol.
Serum/Plasma: No significant interference up to 30.0 mg/dL unconjugated bilirubin, 3000 mg/dL triglycerides, 500 mg/dL hemoglobin, 20.0 mg/dL Uric acid, 500 mg/dL Glucose, 20 mg/dL Ascorbic acid, 5 mg/dL Creatine, 14.8 mg/dL Conjugated bilirubin. Methyl-dopa, L-dopa, and Calcium dobesilate induce falsely low results. Monoclonal gammopathies can cause unreliable results.
Urine: No significant interference up to 29.5 mg/dL Conjugated bilirubin, 500 mg/dL Hemoglobin, 20 mg/dL Ascorbic acid, 50.0 mg/dL Calcium dobesilate, 539 mg/dL Glucose, 10 mg/dL Methyldopa.
a. Method comparison:
Study type: Correlation study according to CLSI EP09-A2 protocol.
Sample size: 100 serum patient samples (0.10 to 30.1 mg/dL) and 54 urine patient samples (3 to 413 mg/dL).
Key results: Serum/Plasma: y = 0.979x + 0.05 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 0.09 mg/dL. Urine: y = 1.063x + 2 mg/dL, r = 1.000, r2 = 0.999, Sy.x = 4 mg/dL.
b. Comparison study: Matrix comparison:
Study type: Matrix comparison study according to CLSI EP09-A2 protocol.
Sample size: 43 plasma patients (0.11 to 30.23 mg/dL).
Key results: y = 0.981x + 0.03 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 0.09 mg/dL.
d. Clinical Studies: Not applicable
e. Clinical Cut-off: Not applicable
Key Metrics
Not Found
Predicate Device(s)
K024098 Roche Diagnostics Creatinine plus ver 2, K033501 Roche Diagnostics Calibrator for Automated Systems (C.f.a.s.), K041227 Roche Diagnostics Precinorm and Precipath, K020817 BIO-RAD Liquichek Urine Chemistry Control Level 1 and Level 2
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
0
510(k) Summary
JAN - 3 2014
ELITech Clinical Systems CREATININE PAP SL
Zone Industrielle
61500 SEES FRANCE
Class II JFY
Class II JIX
Clinical Chemistry 21 CFR 862.1225
Clinical Chemistry 21 CFR 862.1150
July 29, 2013 Date: Submitter: ELITech Clinical Systems SAS
-
Contact Person:
Debra K. Hutson Director, QARA, North America 21720 23dd Dr SE, Suite 150 Bothell, WA 98021 Phone: 425-482-5174 Fax: 425-482-5550 Email: d.hutson@elitechgroup.com
ELITech Clinical Systems ELICAL 2
ELITech Clinical Systems CREATININE PAP SL
Device Description: Classification
Device Description: Classification
Device Description: Classification
Device Description: Classification
Predicate Device:
ELITech Clinical Systems ELITROL I and ELITROL II Class I. JJY Clinical Chemistry 21 CFR 826.1660
ELITech Clinical Systems URINE CONTROL BI-LEVEL Class I, JJY Clinical Chemistry 21 CFR 826.1660
K024098 Roche Diagnostics Creatinine plus ver 2
K033501 Roche Diagnostics Calibrator for Automated Systems (C.f.a.s.)
K041227 Roche Diagnostics Precinorm and Precipath
.
1
K020817 BIO-RAD
Liquichek Urine Chemistry Control Level 1 and Level 2
Intended Use
Reagents:
Calibrators:
Controls:
ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine on ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
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 Pro Series Analyzers.
ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
Special conditions for use statement(s):
Prescription Use Only. It is not intended for use in Point of Care settings.
Special instrument requirements:
Performance was provided for the ELITech Clinical Systems Selectra ProM Analyzer.
Page 2 of 14
2
Device Descriptions
ELITech Clinical Systems CREATININE PAP SL is available as kit only. It consists of a bi-reagent R1 and R2 whose composition is, for R1: MOPS buffer (pH 7.50), EHSPT, Creatinase, Sarcosine oxidase, Ascorbate oxidase. For R2: MOPS buffer (pH 7.50), 4-Aminoantipyrine, Creatininase, Peroxidase, sodium azide.
ELITech Clinical Systems ELICAL2 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 the antibodies to HCV and HIV according to FDA-approved methods.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of a 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.
ELITech Clinical Systems URINE CONTROL BI-LEVEL is a liquid solution prepared from human urine supplemented with constituents of human and animal origin, chemicals, preservatives and stabilizers. Human sera corresponding to the URINE CONTROL BI-LEVEL were tested for each urine donor and found to be negative for HbsAg and antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods.
8.
Substantial Equivalence Information -
- Assay (reagent) 1. Predicate Device Name
- Roche Diagnostics Creatinine plus ver 2
-
- Comparison with predicate
Similarities
| Parameter | ELITech Clinical Systems Device
CREATININE PAP SL | Predicate device
Roche Diagnostics Creatinine plus ver.2 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
/ Indication for
Use | Intended for the quantitative in vitro
diagnostic determination of creatinine
in human serum, plasma and urine on
ELITech Clinical Systems Selectra Pro
Series Analyzers. It is not intended for
use in Point of Care settings.
Creatinine measurements are used in
the diagnosis and treatment of renal
diseases, in monitoring renal dialysis,
and as a calculation basis for
measuring other urine analytes. | For in vitro diagnostic use in the
quantitative determination of creatinine
in serum, plasma and urine on the
cobas c111 system. |
| Specimen
Type | Serum, Plasma, Urine | Same |
| Assay
Technology | Enzymatic colorimetric test | Same |
| Parameter | ELITech Clinical Systems Device
CREATININE PAP SL | Predicate device
Roche Diagnostics Creatinine plus ver.2 |
| Assay Range | Serum/plasma: 0.10 - 30 mg/dL
Urine: 5 - 450 mg/dL. | Serum/plasma: 0.06 - 30.5 mg/dL
Urine: 1.1 - 452 mg/dL. |
| Instrument | Selectra ProM analyzer | cobas c111 |
| Calibrator | Recommended calibration material
(not included):
ELITech Clinical Systems ELICAL 2 | Recommended calibration material
(not included):
Roche Calibrator f.a.s. |
| Interferences- | Serum/Plasma | Serum/Plasma |
| | Unconjugated bilirubin: No significant
interference up to 30.0 mg/dL.
Conjugated bilirubin: No significant
interference up to 14.8 mg/dL. | Icterus: No significant influence up to I
Index of 20 (approximate conjugated
and unconjugated bilirubin
concentration of 20 mg/dL (342
µmol/L)). |
| | Hemoglobin: No significant
interference up to 500 mg/dL.
Triglycerides: No significant
interference up to 3000 mg/dL.
Uric acid: No significant interference
up to 20.0 mg/dL.
Glucose: No significant interference
up to 500 mg/dL.
Ascorbic acid: No significant
interference up to 20 mg/dL.
Methyl-dopa: Induce falsely low
results at therapeutic concentrations.
L-dopa: Induce falsely low results at
| Hemoglobin: No significant interference
up to an H Index of 800 (approximate
800 mg/dL).
Lipemia (Intralipid): No significant
influence up to an L index of 1000.
There is poor correlation between the L
index (corresponds to turbidity) and
triglycerides concentration.
Ascorbic acid: 1mmol/L causes falsely high results.
2-Phenyl-1,3 indandion (Phenindion) at
therapeutic concentrations interference
with the assay. |
| | | Cyanokit (Hidroxocobalamin) may
cause interference with results: |
| Parameter | ELITech Clinical Systems Device
CREATININE PAP SL | Predicate device
Roche Diagnostics Creatinine plus ver.2 |
| | | Other: In very rare cases monoclonal
gammopathy can lead to incorrect
results. |
| | | No significant interference up to a
creatine level of 0.38 mmol/L (5 mg/dL). |
| Interferences -
Urine | Urine | Urine |
| | Conjugated bilirubin: No significant
interference up to 29.5 mg/dL. | Drugs: No interference was found at
therapeutic concentration using |
| | Hemoglobin: No significant
interference up to 500 mg/dL. | common drugs panels.
Exception: Levodopa causes artificially |
| | Ascorbic acid: No significant
interference up to 20 mg/dL. | low results. High homogentisic acid
concentrations in urine samples lead to
false results. |
| | Methyl-dopa: No significant
interference up to 10 mg/dL. | Other: No significant interference up to
a creatinine level of 3.05 mmol/L (40
mg/dL) |
| | Calcium dobesilate: No significant
interference up to 50.0 mg/dL | |
| | Glucose: No significant interference
up to 5000 mg/dL. | |
| | Serum/plasma: | Serum/plasma: |
| | Adults : | Adults : |
| Reference
Range | Females 0.55 - 1.02 mg/dL | Females 0.51 - 0.95 mg/dL |
| | Males 0.72 - 1.18 mg/dL | Males 0.67 - 1.17 mg/dL |
| | | Children: |
| | Urine: | Neonates(premat.) 0.33-0.98 mg/dL |
| | Females 11 - 20 | Neonates(full term) 0.31-0.88 mg/dL |
| | mg/kg/24h | 2-12 m
0.16-0.39 mg/dL |
| | Males 14 - 26 | 1-in vitro diagnostic use in quality
control of quantitative ELITech
Clinical Systems methods on ELITech
Clinical Systems Selectra Pro Series
Analyzers. | Precinorm U is for use in quality
control by monitoring accuracy and
precision for the quantitative methods.
as specified in the value sheets.
Precipath U is for use in quality
control by monitoring accuracy and
precision for the quantitative methods
as specified in the value sheets. |
| Format | Lyophilized human sera with constituents
added as required to obtain defined
component levels | Same |
| Levels | Two Levels (Level I and Level II) | Same |
| 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) | Same |
Urine Control .
- Predicate Device Name:
Biorad Liquichek Urine Chemistry Control Level 1 and Level 2
-
Comparison with predicate
Similarities and Differences
| Item | ELITech Clinical Systems Device
URINE CONTROL BI -LEVEL | Predicate Device Biorad Liquichek
Urine Chemistry Control Level 1 and
Level 2 (K020817) |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Intended
use | ELITech Clinical Systems URINE
CONTROL BI - LEVEL is a set of 2 levels
of urine controls for in vitro diagnostic
used in the quality control of quantitative | Liquichek Urine Chemistry Control is
intended for use as unassayed quality
control urine. |
Page 6 of 14
6
Similarities and Differences
| Item | ELITech Clinical Systems Device
URINE CONTROL BI -LEVEL | Predicate Device Biorad Liquichek
Urine Chemistry Control Level 1 and
Level 2 (K020817) |
|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ELITech Clinical Systems methods on
ELITech Clinical Systems Selectra Pro
Series Analyzers | |
| Format | Liquid ready to use, a liquid solution
prepared from human urine supplemented
with constituents of human and animal
origin, chemicals, preservatives and
stabilizers. | Liquid form, prepared from prepared
from human urine supplemented with
constituents of human and animal
origin, chemicals, preservatives and
stabilizers. |
| Levels | Two levels | Same |
| Stability | - Before opening:
Each control is stable until the expiry date
stated on the label.
- After opening:
Each control is stable for 30 days when
stored tightly-closed between 2-8 °C. - Creatinine values may gradually
decrease over the product shelf life.
Individual laboratory means may
eventually fall outside of the
corresponding ranges indicated in the
value sheet included in the kit. | Same |
Calibrator
- Predicate Device Name:
- Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)
-
- Comparison with predicate
Similarities and Differences
| Item | ELITech Clinical Systems Device
ELICAL 2 | Predicate
Roche Calibrator for Automated
Systems (C.f.a.s.) K033501 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 ELITech Clinical Systems
Selectra Pro Series 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
requires to obtain desired component
levels | Same |
| Level | Single Level | Same |
7
Similarities and Differences
| Item | ELITech Clinical Systems Device
ELICAL 2 | Predicate
Roche 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
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) | Same |
9. Standard/Guidance Document Reference
- Evaluation of Precision Performance of Quantitative Measurement Methods; . Approved Guideline-Second Edition. CLSI (NCCLS) document EP05-A2, Vol 24, No. 25, August 2004.
- . Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline. CLSI (NCCLS) document EP17-A, vol 24, No. 34, October 2004.
- . Method Comparison and Bias estimation Using Patient Samples; Approved Guideline-Second Edition. CLSI (NCCLS) document EP09-A2-IR, Vol 30, No. 17, July 2010.
- . Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use: Guidance for Industry and FDA Staff, November 2004.
- . Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI (NCCLS) document EP07-A2, Vol 25, No. 27, November 2005.
- . Evaluation of the Linearity of the Measurement of Quantitative Procedures: a Statistical Approach; Approved Guideline. CLSI (NCCLS) document EP06-A, Vol 23, No. 16, April 2003.
8
10. Test Principle:
Creatininase hydrolyzes creatinine in sample to creatine is hydrolyzed by creatinase to sarcosine and urea. Sarcosine is then oxidized by sarcosine oxidase to produce hydrogen peroxide (H2O2). H2O2 reacts with 4-amino-antipyrine (4-AAP) and EHSPT (N-Ethyl-N-2(-Hydroxy-3-Sulfopropyl)-m- Toluidine) under the catalytic action of peroxidase to form a colored quinoneimine. The absorbance of the quinoneimine at 546 nm is proportional to the concentration of creatinine in the sample.
4-AAP: Amino-4-antipyrine EHSPT : N-Ethyl-N-2(-Hydroxy-3-Sulfopropyl)-m-Toluidine
11. Performance Characteristics - Analytical Performance
a. Precision/Reproducibility
The precision of the device was determined in accordance with Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline-Second Edition. CLSI (NCCLS) document EP05-A2, Vol 24, No. 25, August 2004.
Within-run and total precision results were obtained by performing two runs per day, two measures per run, for 3 levels of samples on 2 instruments during twenty operating days according to CLSI EP05-A2 protocol. The results are presented in the table below:
Precision
Serum/Plasma
| Level | n | Mean (mg/dL) | Precision % | |
|---|---|---|---|---|
| Within-run CV% | Total CV% | |||
| Level 1 | 80 | 0.76 | 1.2% | 1.9% |
| Level 2 | 80 | 1.52 | 0.6% | 1.7% |
| Level 3 | 80 | 5.52 | 0.5% | 1.5% |
9
Urine
| Level | n | Mean (mg/dL) | Precision % | |
|---|---|---|---|---|
| Within-run CV% | Total CV% | |||
| Level 1 | 80 | 83 | 0.8% | 2.2% |
| Level 2 | 80 | 159 | 0.7% | 2.3% |
| Level 3 | 80 | 308 | 1.9% | 2.9% |
b. Linearity/assay reportable range
The linearity study of CREATININE PAP SL reagent was performed according to CLSI protocol EP06-A.
Serum/Plasma: From this study, a measuring range from 0.10 to 30 mg/dL has been determined.
Manual dilution 1 to 5 allows an upper linearity of CREATININE PAP SL reagent to 150 mg/dL.
Urine: From this study, a measuring range from 5 to 450 mg/dL has been determined.
c. Traceability
For calibration, a multi-parametric calibrator named ELITech Clinical Systems ELICAL 2 (manufactured by ELITech Clinical Systems SAS under product code CALI-0580) must be used. Its value is traceable to the ID-MS (Isotope Dilution -Mass Spectrometry) reference method.
d. Stability
Real-time stabilities:
On board stability for the ELITech Clinical Systems CREATININE PAP SL was established by real time studies on the ELITech Clinical Systems Selectra Analyzer. The on-board stability of the reagent is 28 days. The shelf-life of CREATININE PAP SL reagent has been followed in the real time for 20 months on 3 different batches.
Serum control material is purchased from a commercial vendor (previously cleared under K041227). The following is claimed for stability: Before reconstitution, the shelf-life of the ELITech Clinical Systems ELITROL I and ELITROL II is 24 months at 2-8°C. After reconstitution the stability is 12 hours when stored at 15-25℃, 5 days when stored at 2-8°C or 4 weeks (when frozen once) at -25° and -15° C.
Calibrator material is purchased from a commercial vendor (previously cleared under K033501). The following is claimed for stability: Before reconstitution, the shelf-life of ELITech Clinical Systems Elical 2 is stable 24 months at 2-8°C. After reconstitution the stability is 8 hours when stored at 15-25°C, 2 days at 2-8°C or 4 weeks (when frozen once) at -25°and -15°C. The labeling stated that the Elical 2 should be stored tightly capped and protected from light when not in use.
Urine control material is purchased from commercial vendor (preciously cleared under K020817). The following is claimed for stability: ELITech Clinical Systems URINE CONTROL BI-LEVEL is stable 10 months at 2-8°C. After opening, each control is stable for 30 days when stored tightly closed at 2-8°C.
10
d. Stability (continued)
Creatinine values may gradually decrease over the product shelf life. Individual laboratory means may eventually fall outside of the corresponding ranges indicated in the value sheet included in the kit.
Value Assignment
Elitrol I and II are value assigned using multiple ELITech Clinical Systems Selectra ProM Series Analyzers. Each sample is tested in triplicate over several days. The target value of Level I and II are the median of the observed values range. After validation of the target value, a confidence range (high and low values) is then calculated.
Elical 2 is tested against predetermined values on one ELITech Clinical Systems Selectra ProM Series Analyzers using the CREATININE PAP SL reagent and 2 levels of quality control material. The mean analyte value is calculated and a target value is assigned.
URINE CONTROL BI-LEVEL value is assigned using multiple ELITech Clinical Systems Selectra Series Analyzers. The target value of Level I and II are the median of the observed values range. After validation of the target value, a confidence range (high and low values) is then calculated.
e. Detection limit
Determined according to CLSI protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).
Serum/Plasma
Limit of Detection (LoD) of CREATININE PAP SL obtained from 15 measurements of 4 samples with a low concentration of analyte (approximately 4 x LoB = 0.04 mg/dL) is 0.02 mg/dL.
Limit of Quantification (LoQ) of CREATININE PAP SL obtained from 15 measurements of 4 samples at nominal concentration 0.08 md/dL is 0.08 mg/dL.
Urine
Limit of Detection (LoD) of CREATININE PAP SL obtained from 15 measurements of 4 samples with a low concentration of analyte is 0.5 mg/dL.
Limit of Quantification (LoQ) of CREATININE PAP SL obtained from 15 measurements of 4 samples is 2.0 mg/dL.
11
f. Interference/analytical specificity
Interferences due to unconjugated bilirubin, conjugated bilirubin, triglycerides, hemoglobin, ascorbic acid, uric acid, glucose, methyl-dopa, L-dopa, calcium dobesilate and creatine were investigated following the recommended sample levels in CLSI EP07-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition). The results of testing interferences are the following:
Serum/Plasma
- Concentration up to 30.0 mg/dL unconjugated bilirubin, 3000 mg/dL triglycerides, 500 mg/dL hemoglobin, 20.0 mg/dL Uric acid, 500 mg/dL Glucose, 20 mg/dL Ascorbic acid, 5 mg/dL Creatine, 14.8 mg/dL Conjugated bilirubin do not show any significant interference for each substance.
- Methyl-dopa, L-dopa and Calcium dobesilate induce falsely low results at therapeutic concentrations.
- In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM type (Waldenstrom's macroglobulinemia) can cause unreliable results.
Urine
- Concentration up to 29.5 mg/dL Conjugated bilirubin, 500 mg/dL Hemoglobin, 20 mg/dL ı Ascorbic acid, 50.0 mg/dL Calcium dobesilate, 539 mg/dL Glucose, 10 mg/dL Methyldopa do not show any significant interference for each substance.
The following statement will also be included in the labeling:
Other compounds may interfere. Users should refer to the two following literature references:
-Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 200 Ed., AACC Press, (1997).
-Young, D. S., Effects of drugs on clinical laboratory tests, 40 Ed., AACC Press, (1995). -Berth, M. & Delanghe, J. Protein precipitation as a possible important pitfall in the clinical chemistry analysis of blood samples containing monoclonal immunoglobulins: 2 case reports and a review of literature, Acta Clin Belg., (2004), 59, 263.
Performance Characteristics - Comparison Studies 12.
a. Method comparison
Serum/Plasma
A correlation study was performed between CREATININE PAP SL reagent on a Selectra Pro Series Analyzer and Roche Diagnostics CREP2 (Creatinine Plus ver 2) reagent on a cobas c111 analyzer according to CLSI EP09-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).
This study was performed using 100 serum patient samples from 0.10 to 30.1 mg/dL over a span of 5 days.
Regression analysis of the results vielded the following:
y = 0.979x + 0.05 mg/dL.
r = 1.000
r2 = 1.000
Standard error of the estimate Sy.x = 0.09 mg/dL.
12
Urine
54 urine patient samples ranging from 3 to 413 mg/dL, were tested on Selectra Pro Series Analyzer according to CLSI protocol EP09-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition). Regression analysis of the results yielded the following:
y = 1.063x + 2 mg/dL r = 1.000 r² = 0.999 Standard error of the estimate Sy.x = 4 mg/dL
b. Comparison study: Matrix comparison
43 plasma patients (in lithium heparin samples, ranging from 0.11 to 30.23 mg/dL), were a tested on a Selectra Pro Series Analyzer according to CLSI protocol EP09-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).
Regression analysis of the results yielded the following:
y = 0.981x + 0.03 mg/dL r = 1.000 r2 = 1.000 Standard error of the estimate Sy x = 0.09 mg/dL.
c. Expected values/Reference Range
As indicated in the instructions for use for CREATININE PAP SL, each laboratory should establish and maintain its own reference values. The values given are used as guidelines only.
| Men | Woman | ||
|---|---|---|---|
| Serum/ Plasma | 0.72 - 1.18 | 0.55 - 1.02 | mg/dL |
| 64 - 104 | 49 - 90 | μmol/L | |
| Urine | 14 - 26 | 11 - 20 | mg/dL/kg/24h |
| 124 - 230 | 97 - 177 | μmol/L/kg/24h |
These reference values are from:
Newman, D.J., Price C.P., Tietz Fundamentals of Clinical Chemistry, 5th Ed., Burtis, C.A. & Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA), (2001), 414.
Ceriotti, F., Reference Intervals for Serum Creatinine Concentrations: Assessment of Available Data for Global Application. Clin. Chem., (2008), 54, 559.
13
and the comments of
.
- d. Clinical Studies:
Not applicable
e. Clinical Cut-off:
Not applicable
-
- Conclusion
The information on the principle and performance of our device that is contained in this premarket notification is complete and supports a decision that our device is substantially equivalent to the predicate device.
- Conclusion
.
Page 14 of 14
.
14
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2014
ELITECH GROUP DEBRA K. HUTSON DIRECTOR, RA/QA, NORTH AMERICA 21720 23RD DR S.E., SUITE 150 BOTHELL WA 98021
Re: K132399
Trade/Device Name: ELITech Clinical Systems Creatinine PAP SL
ELITech Clinical Systems ELICAL 2
ELITech Clinical Systems ELITROL I and ELITech Clinical Systems ELITROL II
ELITech Clinical Systems URINE CONTROL BI-LEVEL
Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: II Product Code: JFY, JIX, JJY Dated: December 4, 2013 Received: December 5, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements,
15
Page 2-Ms. Hutson
as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
16
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132399
Device Name
ELITech Clinical Systems CREATININE PAP SL ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I and ELITech Clinical Systems ELITROL II ELITech Clinical Systems URINE CONTROL BI-LEVEL
・
Indications for Use (Describe)
ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in huntan serum, plasma and urine on ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in the callbration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems ELITROL I are multi-parameric control sera for in vitro diagnosic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems URINE CONTROL BI- LEVEL is a set of 2 levels of urine controls used for in virro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITical Systems Selectra Pro Series Analyzers.
Type of Use (Select one or both, as applicable)
X 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 A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)