K Number

Device Name

ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL

Manufacturer

ELITECHGROUP

Date Cleared

2013-02-15

(207 days)

Product Code

JIT JJX

Regulation Number

862.1150

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 Description

ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is an aqueous solution ready to use containing bovine albumin at a concentration of 100 mg/dL and sodium azide (< 0.1 %). 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. These controls are prepared exclusively from the human urine where each urine donation is tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K092570, K020817

Reference Devices

K092570, K020817

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a calibration standard and a quality control material for a urine protein test, not a device that processes data or makes decisions using AI/ML. The description focuses on the chemical composition and intended use for calibration and quality control. There is no mention of any computational or analytical capabilities beyond standard laboratory testing procedures.

Therapeutic

No
The device is described as a calibrator and control for in vitro diagnostic testing, not as a device used to treat or cure a disease or condition in a patient.

Diagnostic

No
The devices described are a calibration standard and a quality control material for diagnostic tests, not diagnostic devices themselves. They are used to ensure the accuracy and reliability of diagnostic instruments and methods.

SaMD (Software as a Medical Device)

The device description clearly indicates the device is a liquid solution containing biological and chemical components, intended for calibration and quality control of laboratory analyzers. This is a reagent, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The document explicitly states that the URINE CONTROL BI-LEVEL is "used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods". This directly aligns with the definition of an IVD, which is a device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information for diagnostic, monitoring or compatibility purposes.
Device Description: The description of both the standard and the control indicates they are used with human urine specimens ("prepared from human urine").
Predicate Devices: The listed predicate devices (HORIBA ABX PENTRA TPU Cal and Biorad Liquicheck Urine Chemistry Control) are also IVD devices used in clinical laboratories for calibration and quality control of urine chemistry tests. This further supports the classification of this device as an IVD.

While the standard is for calibration and the control is for quality control, both are essential components of an in vitro diagnostic testing system used to provide reliable results for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

JIT, JJX

Device Description

ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is an aqueous solution ready to use containing bovine albumin at a concentration of 100 mg/dL and sodium azide (

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
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.)(b)
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.

Summary

510(k) Summary			FEB
Introduction	According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of sub-
stantial equivalence.
	The assigned 510(k) number is: K122177
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 | July 9, 2012 | | |
| Device names | | | |
| CALIBRATOR
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
aqueous solution ready to use containing bovine albumin at a concentration of
100 mg/dL and sodium azide (in vitro diagnos-
tic used in the quality control of quanti-
tative ELITech Clinical Systems meth-
ods on ELITech Clinical Systems Se-
lectra Pro Series Analyzers | Liquicheck Urine Chemistry Control is
intended for use as an assayed quality
control urine. |
| Format | Liquid ready to use, a liquid solution
prepared from human urine supple-
mented with constituents of human and
animal origin, chemicals, preservatives
and stabilizers. | Liquid form, prepared from human
urine supplemented with constituents
of human and animal origin, chemicals,
preservatives and stabilizers. |
| Levels | 2 Levels | 2 Levels |
| Stability | - Before opening:
Each control is stable until the expiry
date stated on the label.

After opening:
Each control vial is stable for 30 days | Product is stable until the expiration
date when stored unopened at 2 to
8 °C. Once the control is opened, it is
stable 30 days when stored tightly
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.

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.

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

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

Indications for Use Form

510(k) Number (if known): K122177

Device Name: ELITech Clinical Systems URINE CONTROL BI-LEVEL