(366 days)
Not Found
No
The device description and performance studies focus on chemical reagents and standard analytical methods, with no mention of AI/ML components or data-driven algorithms.
No.
This device is an in vitro diagnostic reagent kit used for the quantitative determination of creatinine in human serum and plasma, which is for diagnostic purposes rather than therapeutic intervention.
Yes
The document explicitly states the device is "intended for the quantitative in vitro diagnostic determination of creatinine in human serum and plasma". It also mentions that "Creatinine measurements are used in the diagnosis and treatment of renal diseases". This clearly indicates its purpose is for diagnosis.
No
The device is a kit containing chemical reagents for in vitro diagnostic testing, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is for "quantitative in vitro diagnostic determination of creatinine in human serum and plasma".
- Device Description: The device is a kit containing reagents used to perform a test on biological samples (serum and plasma).
- Purpose: The test is used in the "diagnosis and treatment of renal diseases, and in monitoring renal dialysis," which are clinical purposes.
All of these points align with the definition of an In Vitro Diagnostic device.
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 and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.
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 Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzers.
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 analyzers.
Product codes
JFY, JJY, JIX
Device Description
The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2".
Reagent R1 contains: MOPS buffer (pH 7.50), EHSPT (N-Ethyl-N-2(-Hydroxy-3-Sulfopropyl)-m-Toluidine), Creatinase (microoganism), Sarcosine oxidase (microoganism), Ascorbate oxidase (vegetal).
Reagent R2 contains: MOPS buffer (pH 7.50), Amino-4-antipyrine (4-AAP), Creatininase (bacterial), Peroxidase (horseradish), and Sodium azide.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II 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
Adults
Children: Neonates (premat.), Neonates (full term), 2-12 m, 1-3 y, 3-5 y, 5-7 y, 7-9 y, 9-11 y, 13-15 y
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison chart between subject device and predicate device.
Measuring range: 0.28 - 22.30 mg/dL
Limit of detection (LoD): 0.006 mg/dL
Limit of quantification (LoQ): 0.28 mg/dL
Precision (Within run): Level 0.59 mg/dL CV=1.3%, Level 1.62 mg/dL CV=0.8%, Level 6.93 mg/dL CV=1.4%
Precision (Total): Level 0.59 mg/dL CV=3.2%, Level 1.62 mg/dL CV=1.6%, Level 6.93 mg/dL CV=2.8%
Method comparison: y=1.045x - 0.01 mg/dL, r= 0.999, range: 0.30 to 20.30 mg/dL
Limitations:
Hemoglobin: No significant interference up to 500 mg/dL.
Triglycerides: No significant interference up to 3198 mg/dL.
Unconjugated bilirubin: No significant interference up to 30.0 mg/dL.
Conjugated bilirubin: No significant interference up to 14.8 mg/dL.
Uric acid: No significant interference up to 24 mg/dL.
Glucose: No significant interference up to 550 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 therapeutic concentrations.
Calcium dobesilate: Induce falsely low results at therapeutic concentrations.
Creatine: Positive bias from 5 mg/dL.
Calibration Frequency: 14 days
On board stability: refrigerated area: 28 days
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.
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
§ 862.1225 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
/S2
SECTION 5 - 510(k) Summary
ELITech Clinical Systems CREATININE PAP SL
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of sub-
stantial equivalence. | | ELITech Clinical Systems Device
CREATININE PAP SL | Predicate device
(Roche Diagnostics Creatinine plus
ver.2) |
|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The assigned 510(k) number is: K103376 | Intended use | Intended for the quantitative in vitro
diagnostic determination of creatinine
in human serum or plasma on Vital
Scientific Selectra/Flexor analyzers.
It is not intended for use in Point of
Care settings. | For in vitro diagnostic use in the quan-
titative determination of creatinine in
serum, plasma and urine on the cobas
c111 system. |
| 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 for Use | Creatinine measurements are used in
the diagnosis and treatment of renal
diseases, and in monitoring renal
dialysis. | Creatinine measurements are used in
the diagnosis and treatment renal
diseases, in monitoring renal dialysis
and as a calculation basis for measur-
ing other urine analytes. |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Assay protocol | Enzymatic colorimetric test | Enzymatic colorimetric test |
| Date of Preparation | November 8th, 2010 | Composition | Reagent R1:
MOPS buffer (pH 7.50)
EHSPT
$0.4 ormal{mmol/L};$
Creatinase
$\ge 10 000 ormal{U/L};$
Sarcosine oxidase
$\ge 3 250 ormal{U/L};$
Ascorbate oxidase
$\ge 1 000 ormal{U/L};$
Reagent R2: | Reagent R1:
TAPS buffer
$30 ormal{mmol/L};$
Creatinase
$\ge 332 \mu ormal{kat/L};$
Sarcosine oxidase
$\ge 132 \mu ormal{kat/L};$
Ascorbate oxidase
$\ge 33 \mu ormal{kat/L};$
HITB
$1.2 ormal{g/L};$
Detergents
Preservative |
| Device names | | | MOPS buffer (pH 7.50)
4-Aminoantipyrine
$2.95 ormal{mmol/L};$
Creatininase
$\ge 150 000 ormal{U/L};$
Peroxidase
$\ge 4 000 ormal{U/L};$
Sodium azide
$m -Toluidine), Creatinase (microoganism), Sarcosine
oxidase (microoganism), Ascorbate oxidase (vegetal).
Reagent R2 contains: MOPS buffer (pH 7.50), Amino-4-antipyrine (4-AAP),
Creatininase (bacterial), Peroxidase (horseradish), and Sodium azide. | Reagent storage | Store at 2-8 °C and protect from light.
The reagent is stable until the expiry
date stated on the label. | Stored at 2-8 °C.
Reagents are stable until the expiry
date stated on the label. |
| Intended Use | ELITech Clinical Systems CREATININE PAP SL is intended for the quantita-
tive in vitro diagnostic determination of CREATININE in human serum and
plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for
use in Point of Care settings. | Expected values | Serum/plasma:
Adults :
Females 0.55 - 1.02 mg/dL
Males 0.72 - 1.18 mg/dL | Serum/plasma:
Adults :
Females 0.51 - 0.95 mg/dL
Males 0.67 - 1.17 mg/dL
Children:
Neonates(premat.) 0.33-0.98 mg/dL
Neonates(full term) 0.31-0.88 mg/dL
2-12 m
0.16-0.39 mg/dL
1-in vitro diagnostic use in the
calibration of quantitative ELITech
Clinical Systems methods on Vital
Scientific Selectra Junior Analyzer
and Vital Scientific Flexor Junior
Analyzer. | For in vitro diagnostic use in the
calibration of quantitative Roche
methods on Roche clinical chemis-
try analysers as specified in the
value sheets. |
| Format | Lyophilized calibrator based on
human serum with constituents
added as required to obtain desired
components levels | Lyophilized calibrator based on
human serum with constituents
added as required to obtain desired
components levels |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding the
loss of lyophilate, and pipette in
exactly 3 mL of distilled/deionized
water. Carefully close the vial and
dissolve the contents completely by
occasional gentle swirling within 30
minutes avoiding the formation of
foam. | Carefully open one bottle, avoiding
the loss of lyophilate, and pipette in
exactly 3 mL of distilled/deionized
water. Carefully close the bottle and
dissolve the contents completely by
occasional gentle swirling within 30
minutes. Avoid the formation of
foam. |
| Traceability | Traceability information is given in
the value sheet included in the box. | Traceability of the target value is
given in the respective instruction
for use of the system reagents. |
| 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) | Lyophilized:
Stable at 2-8°C up to expiration
date.
After reconstitution, the stabilities*
are :
- 8 hours at 15-25 °C.
- 2 days at 2-8 °C.
- 4 weeks at (-25)-(-15) °C (when
frozen once)
*Exception for bilirubin total & direct
as noted in package insert |
4
Comparison to Predicate device
5
،
Device names
| CONTROLS:
Trade/proprietary Name:
Common or Usual Name:
Device Class
Classification name
Product code | ELITech Clinical Systems ELITROL I and ELITROL II
Multi-analyte controls - all kinds, "ELITROL I"- "ELITROL II"
Class I
Quality control material (assayed and unassayed). (21 CFR
862.1660) |
|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | JJY- Multi-analyte controls - all kinds |
| Predicate device | Roche Diagnostics Precinorm U (K041227)
Roche Diagnostics Precipath U (K041227) |
| Device description | ELITech Clinical Systems ELITROL I and ELITROL II are two level quality
control products consisting of lyophilized human serum containing constituents
at desired levels.
Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested
individually and found to be negative for HbsAg and to antibodies to HCV and
HIV according to FDA-approved methods or methods in compliance with the
European Directive 98/79/EC, Annex II, List A. |
| Intended Use | ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric
control sera for in vitro diagnostic use in accuracy control of quantitative
ELITech Clinical Systems methods on Vital Scientific Selectra Junior Analyzer
and Vital Scientific Flexor Junior Analyzer. |
6
Comparison to Predicate device
| ELITech Clinical Systems Device | Predicate Device | |
|---|---|---|
| ELITROL I / ELITROL II | Roche Precinorm U / Precipath U | |
| Intended use | ELITech Clinical Systems ELITROL | |
| I and ELITROL II are multi- | ||
| parametric control sera for in vitro | ||
| diagnostic use in accuracy control | ||
| of quantitative ELITech Clinical | ||
| Systems methods on Vital Scientific | ||
| Selectra Junior Analyzer and Vital | ||
| Scientific Flexor Junior Analyzer. | For in vitro diagnostic use in quality | |
| control by monitoring accuracy and | ||
| precision for the quantitative meth- | ||
| ods as specified in the value sheet | ||
| Format | Lyophilized human sera with con- | |
| stituents added as required to ob- | ||
| tain desired components levels | Lyophilized human sera with con- | |
| stituents added as required to ob- | ||
| tain desired components levels | ||
| Levels | Two levels | Two levels |
| Handling | Carefully open the vial, avoiding the | |
| loss of lyophilate, and pipette in | ||
| exactly 5 mL of distilled/deionized | ||
| water. Carefully close the vial and | ||
| dissolve the contents completely by | ||
| occasional gentle swirling within 30 | ||
| minutes avoiding the formation of | ||
| foam. | Carefully open the bottle, avoiding | |
| the loss of lyophilate, and pipette in | ||
| exactly 5 mL of distilled/deionized | ||
| water. Carefully close the bottle and | ||
| dissolve the contents completely by | ||
| occasional gentle swirling within 30 | ||
| minutes. Avoid the formation of | ||
| foam. | ||
| Stability | Lyophilized: | |
| To store at 2-8°C and protected | ||
| from light until the expiry date | ||
| After reconstitution, the stabilities | ||
| are : |
- 12 hours between 15-25 °C.
- 5 days between 2-8 °C.
- 4 weeks between -25 and -15 °C
(when frozen once) | Lyophilized:
Stable at 2-8°C up to expiration
date.
After reconstitution, the stabilities*
are : - 12 hours at 15-25 °C.
- 5 days at 2-8 °C.
- 4 weeks at (-25)-(-15) °C (when
frozen once)
*Exception for bilirubin total & direct
as noted in package insert |
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of these devices versus 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.
7
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Seppim S.A.S. C/O Debra Hutson Elitechgroup Epoch Biosciences 21720 23td Dr, SE Suite 150 Bothell, Washington 98021
NOV 1 8 2011
Re: K103376
Trade Name: Elitech Clinical Systems Creatinne PAP SL Regulation Number: 21 CFR §862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Codes: JFY, JJY, JIX Dated: October 26, 2011 Received: October 27, 2011
Dear Ms. Hutson
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
8
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/Medical Devices/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/ResourcesforYou/Industry/default.htm
Sincerely yours,
N.
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
Indications for Use Form
510(k) Number (if known): K103376
Device Name:
Indications for Use:
ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103376
Page 1 of 3
10
Indications for Use Form
510(k) Number (if known): _k103376 __________________________________________________________________________________________________________________________________________
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 Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_k103376
11
Indications for Use Form
510(k) Number (if known): _k103376 ___________________________________________________________________________________________________________________________________________
ELITech Clinical Systems ELITROL I Device Name: ELITech Clinical Systems ELITROL 11
Indications for 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 analyzers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C. A. Z.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103376