(207 days)
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.
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.
This document describes two devices, a calibrator and a control, for urine total protein measurements. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and expert reviews. Therefore, much of the requested information regarding study design, sample sizes, expert qualifications, and ground truth establishment is not available in these documents.
Here's an attempt to answer based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision, sensitivity, specificity) with specific numerical targets. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices through a comparison of intended use, format, levels, traceability, and stability. The reported "performance" is the equivalence itself.
| Feature / Criteria | ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL (Calibrator) | ELITech Clinical Systems URINE CONTROL BI-LEVEL (Control) |
|---|---|---|
| Intended Use | Calibration of quantitative ELITech Clinical Systems URINE TOTAL PROTEIN on ELITech Clinical Systems Selectra Pro Series Analyzers. | In vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers. |
| Format | Aqueous solution containing bovine albumin and sodium azide. | Liquid solution prepared from human urine supplemented with constituents of human and animal origin, chemicals, preservatives and stabilizers; negative for HbsAg, HCV, and HIV-1/HIV-2 antibodies. |
| Levels | Single level (100 mg/dL) | 2 Levels |
| Traceability | Traceable with SRM 927d | Not explicitly stated; implied by intended use as a control for quantitative methods. |
| Stability (Before opening) | Until expiry date on label. | Until expiry date on label. |
| Stability (After opening) | 3 months when stored tightly-closed at 2-8 °C. | 30 days. |
| Acceptance Criteria Met | Performance data and other information demonstrate that safety and effectiveness are not compromised and met all acceptance criteria, demonstrating substantial equivalence to predicate device. | Performance data and other information demonstrate that safety and effectiveness are not compromised and met all acceptance criteria, demonstrating substantial equivalence to predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a clinical or analytical study with a defined sample size for the purpose of primary performance evaluation. The information provided is a premarket notification (510(k)) which aims to demonstrate substantial equivalence to existing legally marketed devices. This typically involves analytical performance data generated by the manufacturer to support the claims, but the specific details of sample sizes for such internal validation studies are not usually included in the public 510(k) summary.
Thus, there is no explicit mention of:
- Sample size used for a test set.
- Data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of information is generally relevant for AI/CADe devices where expert consensus or pathological diagnosis establishes ground truth for image interpretation. For a calibrator and a quality control material like these, "ground truth" refers to the accurately assigned values determined through a rigorous measurement process (e.g., gravimetric methods, certified reference materials, reference methods). This is typically established by the manufacturer's internal processes and is overseen by qualified analytical chemists or scientists, not by "experts" in the clinical interpretation sense.
4. Adjudication method for the test set
Not applicable. As there is no "test set" with expert interpretations being adjudicated, this information is not relevant to the provided documentation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. MRMC studies are specific to AI/CADe devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The devices described here (calibrator and control) are in vitro diagnostic reagents and do not involve human interpretation in the same way.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. These are chemical reagents, not algorithms.
7. The type of ground truth used
For the Calibrator: The calibrator is stated to be traceable to SRM 927d (Standard Reference Material 927d). This likely refers to a National Institute of Standards and Technology (NIST) SRM for total protein, which would be the reference method or certified reference material providing the "ground truth" for the calibrator's assigned value.
For the Control: The control is intended for quality control of quantitative methods. The "ground truth" for control materials is typically established by assigned values determined by the manufacturer using validated methods, often relative to reference materials or established laboratory methods. The document also mentions that each urine donation for the control material is "tested individually and found to be negative for HbsAg and antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods," which contributes to the safety and quality control of the control material itself, rather than establishing a quantitative "ground truth" for a specific analyte measurement.
8. The sample size for the training set
Not applicable. These are not AI/machine learning devices that require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for these types of devices.
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| 510(k) Summary | FEB | ||
|---|---|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination of sub-stantial equivalence. | ||
| The assigned 510(k) number is: K122177 | |||
| SubmitterAddressPhone numberFax 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 | |||
| CALIBRATORTrade/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 anaqueous solution ready to use containing bovine albumin at a concentration of100 mg/dL and sodium azide (< 0.1 %). | ||
| Intended Use | ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL isintended for the calibration of quantitative ELITech Clinical Systems URINETOTAL PROTEIN on ELITech Clinical Systems Selectra Pro SeriesAnalyzers. |
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Comparison to Predicate device
,
| ELITech Clinical Systems Device(URINE TOTAL PROTEINStandard 100 mg/dL) | Predicate device(HORIBA ABX PENTRA TPU Cal(K071779) | |
|---|---|---|
| Intended use | ELITech Clinical Systems URINETOTAL PROTEIN Standard 100mg/dL is intended for the calibrationof quantitative ELITech ClinicalSystems URINE TOTAL PROTEINon ELITech Clinical Systems Selec-tra Pro Series Analyzers. | ABX Pentra TPU Cal is used tocalibrate total proteins in urinemeasurement with ABX PentraUrinary Proteins CP on ABX Pentra400 Analyzers. |
| Format | Aqueous solution ready to use con-taining bovine albumin and sodiumazide. | A liquid ready to use calibratorbased on an aqueous solution con-taining human serum and sodiumazide. |
| Levels | Single level | Single level |
| Traceability | Traceable with SRM 927d | Traceable with SRM927 |
| Stability | - Before opening:Each standard is stable until theexpiry date stated on the label.- After opening:Each standard vial is stable for 3months when stored tightly-closedat 2-8 °C. | In unopened vials, the calibrator isstable up to the expiry date writtenon the label if stored at 2-8 °C.Once opened, the calibrator is stable for9 weeks when stored tightly recappedat 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 solutionprepared from human urine supplemented with constituents of human andanimal origin, chemicals, preservatives and stabilizers.These controls are prepared exclusively from the human urine where eachurine 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(URINE CONTROL BI-LEVEL) | Predicate device(Biorad Liquicheck Urine ChemistryControl, Level 1 and Level 2(K020817)) | |
|---|---|---|
| Intended use | ELITech Clinical Systems URINECONTROL BI-LEVEL is a set of 2 lev-els of urine controls for 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 isintended for use as an assayed qualitycontrol urine. |
| Format | Liquid ready to use, a liquid solutionprepared from human urine supple-mented with constituents of human andanimal origin, chemicals, preservativesand stabilizers. | Liquid form, prepared from humanurine supplemented with constituentsof human and animal origin, chemicals,preservatives and stabilizers. |
| Levels | 2 Levels | 2 Levels |
| Stability | - Before opening:Each control is stable until the expirydate stated on the label.- After opening:Each control vial is stable for 30 days | Product is stable until the expirationdate when stored unopened at 2 to8 °C. Once the control is opened, it isstable 30 days when stored tightlycapped 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_
§ 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.