ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
Device Facts
| Record ID | K122177 |
|---|---|
| Device Name | ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL |
| Applicant | Elitechgroup |
| Product Code | JIT · Clinical Chemistry |
| Decision Date | Feb 15, 2013 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
Intended Use
ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is intended for the calibration of quantitative ELITech Clinical Systems URINE TOTAL PROTEIN 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.
Device Story
The ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is an aqueous solution containing bovine albumin and sodium azide used to calibrate urine protein assays. The ELITech Clinical Systems URINE CONTROL BI-LEVEL is a liquid solution derived from human urine, supplemented with human/animal constituents, preservatives, and stabilizers, used for quality control. Both products are intended for use with ELITech Clinical Systems Selectra Pro Series Analyzers. These devices are used by laboratory professionals to ensure the accuracy and reliability of quantitative urine protein measurements. The calibrator establishes a reference point for the analyzer, while the controls verify the ongoing performance of the assay. Proper calibration and quality control help clinicians obtain accurate diagnostic data for patient management.
Clinical Evidence
No clinical data. Bench testing only. Stability (accelerated and real-time) and value assignment protocols were reviewed and found acceptable. Control material is identical to a previously cleared product (k020817) with only labeling changes.
Technological Characteristics
Calibrator: Aqueous solution, bovine albumin (100 mg/dL), sodium azide (<0.1%). Control: Liquid human urine-based solution with additives. Both are ready-to-use, stored at 2-8°C. Traceability: Calibrator traceable to SRM 927d. No software or electronic components.
Indications for Use
Indicated for use as a calibrator and quality control material for quantitative urine total protein assays on ELITech Clinical Systems Selectra Pro Series Analyzers in a clinical laboratory setting.
Regulatory Classification
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Special Controls
*Classification.* Class II (special 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.
Predicate Devices
- Horiba ABX Pentra TPU Cal (k071779)
- Biorad Liquicheck Urine Chemistry Control, Level 1 and Level 2 (k020817)
Related Devices
- K071779 — ABX PENTRA URINE CAL · Horiba Abx · Mar 5, 2008
- K133676 — ABX PENTRA MICRO ALB CONTROL L/H · HORIBA ABX SAS · Jul 11, 2014
- K052242 — ADVIA CHEMISTRY MICROALBUMIN CONTROLS · Bayer Healthcare, LLC · Oct 3, 2005
Submission Summary (Full Text)
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| 510(k) Summary | | | FEB |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----|
| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of sub-<br>stantial equivalence. | | |
| | The assigned 510(k) number is: k122177 | | |
| Submitter<br>Address<br>Phone number<br>Fax number | SEPPIM S.A.S.<br>Zone Industrielle, 61500 SEES, FRANCE<br>+ 33 (0)2 33 81 21 00<br>+ 33 (0)2 33 28 77 51 | | |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | | |
| Date of Preparation | July 9, 2012 | | |
| Device names | | | |
| <i>CALIBRATOR</i><br>Trade/proprietary Name: | ELITech Clinical Systems URINE TOTAL PROTEIN standard 100 mg/dL | | |
| Common or Usual Name: | Calibrator, "URINE TOTAL PROTEIN Standard 100 mg/dL" | | |
| Device Class | Class II | | |
| Classification name | CFR 862.1150 - calibrator | | |
| Product code | JIT - Calibrator, Secondary | | |
| Predicate device | HORIBA ABX PENTRA TPU Cal (K092570) | | |
| | | | |
| Device description | ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is an<br>aqueous solution ready to use containing bovine albumin at a concentration of<br>100 mg/dL and sodium azide (< 0.1 %). | | |
| Intended Use | ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is<br>intended for the calibration of quantitative ELITech Clinical Systems URINE<br>TOTAL PROTEIN on ELITech Clinical Systems Selectra Pro Series<br>Analyzers. | | |
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## Comparison to Predicate device
,
| | ELITech Clinical Systems Device<br>(URINE TOTAL PROTEIN<br>Standard 100 mg/dL) | Predicate device<br>(HORIBA ABX PENTRA TPU Cal<br>(K071779) |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems URINE<br>TOTAL PROTEIN Standard 100<br>mg/dL is intended for the calibration<br>of quantitative ELITech Clinical<br>Systems URINE TOTAL PROTEIN<br>on ELITech Clinical Systems Selec-<br>tra Pro Series Analyzers. | ABX Pentra TPU Cal is used to<br>calibrate total proteins in urine<br>measurement with ABX Pentra<br>Urinary Proteins CP on ABX Pentra<br>400 Analyzers. |
| Format | Aqueous solution ready to use con-<br>taining bovine albumin and sodium<br>azide. | A liquid ready to use calibrator<br>based on an aqueous solution con-<br>taining human serum and sodium<br>azide. |
| Levels | Single level | Single level |
| Traceability | Traceable with SRM 927d | Traceable with SRM927 |
| Stability | - Before opening:<br>Each standard is stable until the<br>expiry date stated on the label.<br>- After opening:<br>Each standard vial is stable for 3<br>months when stored tightly-closed<br>at 2-8 °C. | In unopened vials, the calibrator is<br>stable up to the expiry date written<br>on the label if stored at 2-8 °C.<br>Once opened, the calibrator is stable for<br>9 weeks when stored tightly recapped<br>at 2-8°C. |
The performance data and other information demonstrate that the safety Conclusion and effectiveness of this device versus the predicate devices is not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
| Device names | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTROLS | |
| Trade/proprietary Name: | ELITech Clinical Systems URINE CONTROL BI-LEVEL |
| Common or Usual Name: | Control, "URINE CONTROL BI-LEVEL" |
| Device Class | Class I |
| Classification name | CFR 862.1660 - Quality control material (assayed and unassayed). |
| Product code | JJX - Control, Single analyte. |
| Predicate device | Biorad Liquicheck Urine Chemistry Control Level 1 and Level 2 (K020817). |
| Device description | ELITEch Clinical Systems URINE CONTROL BI-LEVEL is a liquid solution<br>prepared from human urine supplemented with constituents of human and<br>animal origin, chemicals, preservatives and stabilizers.<br>These controls are prepared exclusively from the human urine where each<br>urine donation is tested individually and found to be negative for HbsAg and to |
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antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods.
#### ELITech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of Intended Use 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.
#### Comparison to Predicate device
| | ELITech Clinical Systems Device<br>(URINE CONTROL BI-LEVEL) | Predicate device<br>(Biorad Liquicheck Urine Chemistry<br>Control, Level 1 and Level 2<br>(K020817)) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems URINE<br>CONTROL BI-LEVEL is a set of 2 lev-<br>els of urine controls for <i>in vitro</i> diagnos-<br>tic used in the quality control of quanti-<br>tative ELITech Clinical Systems meth-<br>ods on ELITech Clinical Systems Se-<br>lectra Pro Series Analyzers | Liquicheck Urine Chemistry Control is<br>intended for use as an assayed quality<br>control urine. |
| Format | Liquid ready to use, a liquid solution<br>prepared from human urine supple-<br>mented with constituents of human and<br>animal origin, chemicals, preservatives<br>and stabilizers. | Liquid form, prepared from human<br>urine supplemented with constituents<br>of human and animal origin, chemicals,<br>preservatives and stabilizers. |
| Levels | 2 Levels | 2 Levels |
| Stability | - Before opening:<br>Each control is stable until the expiry<br>date stated on the label.<br>- After opening:<br>Each control vial is stable for 30 days | Product is stable until the expiration<br>date when stored unopened at 2 to<br>8 °C. Once the control is opened, it is<br>stable 30 days when stored tightly<br>capped at 2 to 8 °C. |
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.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a stylized abstract symbol, often referred to as the "Human Services Symbol," accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The symbol is composed of three curved lines that resemble a stylized human figure or a flame, and it is positioned to the right of the text.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002
## February 15, 2013
ELITechGroup c/o Debra K. Hutson 21720 23rd Dr, S.E., Suite 150 Bothell, WA 98021
Re: k122177
Trade/Device Name: ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL ELITech Clinical Systems URINE CONTROL BI-LEVEL Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT, JJX Dated: December 27, 2012
Received: December 31, 2012
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Ms. Hutson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson 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
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# Indications for Use Form
510(k) Number (if known): __k122177___________________________________________________________________________________________________________________________________________
Device Name: ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL
Indications for Use:
ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is intended for the calibration of quantitative ELITech Clinical Systems URINE TOTAL PROTEIN on . ELITech Clinical Systems Selectra Pro Series 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 Diagnostics and Radiological Health (OIR)
# Ruth A. Cheslers
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
k122177 510(k)
Page 1 of 2
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# Indications for Use Form
510(k) Number (if known): k122177
Device Name: ELITech Clinical Systems URINE CONTROL BI-LEVEL
Indications for Use:
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.
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 Diagnostics and Radiological Health (OIR)
## Ruth A. Cheslers a
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
k122177 510(k)
Page 2 of _2__
