(63 days)
The UREA UV CINETICA AA test system is intended to be used in the quantitative determination of urea in human serum and plasma. Urea measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Kinetic method.
The device is based on the following reaction system:
Urease
Urea + H2O --------> 2 NH3 + CO2
NH3 + NADH + H+ + 2-oxoglutarate --------> I-glutamate + NAD+ + H2O
The provided text describes a 510(k) submission for a medical device, the "Wiener lab. UREA UV CINETICA AA" test system, and its substantial equivalence to a predicate device, the "DMA BUN-KINETIC, UREASE PROCEDURE test system." It outlines the device's intended use, principle, and various performance characteristics.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a pass/fail sense, but rather presents a comparison of the performance characteristics of the proposed device ("WIENER LAB. Test System") against a predicate device ("DMA Test System"). The implicit acceptance criterion is that the Wiener Lab device demonstrates comparable or improved performance relative to the predicate device.
Here's a table summarizing the reported device performance compared to the predicate device:
| Performance Characteristic | Predicate Device (DMA Test System) | Proposed Device (WIENER LAB. Test System) |
|---|---|---|
| Intended Use | Quantitative determination of urea in human serum and plasma. | Quantitative determination of urea in human serum and plasma. (Same) |
| Test Principle | Kinetic method, Urease/GIDH reaction system. | Kinetic method, Urease/GIDH reaction system. (Same) |
| Essential Components | 2-Oxoglutarate - NADH - Urease - GIDH. | 2-Oxoglutarate - NADH - Urease - GIDH. (Same) |
| Working Reagent Stability | 14 days | 30 days |
| Instability/Deterioration of Reagents (Reagent Blank Absorbance) | < 1.100 | < 1.000 |
| Sample | Human serum, heparinized plasmas, EDTA plasmas. | Human serum, heparinized plasmas, EDTA plasmas. (Same) |
| Working Temperatures | 25 - 37°C | 37°C |
| Wavelength of reading | 340 nm | 340 nm |
| Calibration | Single point | Single point |
| Linearity | 100 mg/dl (BUN), 214 mg/dl (urea) | 140 mg/dl (BUN), 300 mg/dl (urea) |
| Minimum detection limit | 0.4 mg/dl (BUN), 0.9 mg/dl (urea) | 1.8 mg/dl (BUN), 3.8 mg/dl (urea) |
| Expected values | 8 - 23 mg/dl (BUN), 17 - 49 mg/dl (urea) | 4.7 - 23 mg/dl (BUN), 10 - 50 mg/dl (urea) |
| Intra-assay precision (Normal Serum Control) | CV = 4.3% | CV = 2.01% |
| Intra-assay precision (Abnormal Serum Control) | CV = 4.1% | CV = 1.19% |
| Inter-assay precision (Normal Serum Control) | CV = 2.9% | CV = 2.36% |
| Inter-assay precision (Abnormal Serum Control) | CV = 6.1% | CV = 1.31% |
The Wiener Lab system demonstrates:
- Improved Reagent Stability: 30 days vs. 14 days.
- Improved Linearity: Higher upper limits for both BUN and urea.
- Higher Minimum Detection Limit: This is a difference, not necessarily an improvement, and could be seen as a negative depending on the clinical context where very low urea levels need to be detected accurately.
- Improved Precision (Lower CVs): Both intra-assay and inter-assay for normal and abnormal serum controls are significantly better than the predicate device.
- Slightly different Expected Values range: The lower end for BUN is lower, and the lower end for urea is slightly higher, while the upper ends are similar.
The document concludes that the data "show substantial equivalency to the predicate device."
Study Design and Information
The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. It summarizes the key performance characteristics without detailing the specific study protocols or designs for generating these numbers. Therefore, much of the requested information about the specific study that proves the device meets the criteria (beyond the direct comparison presented) is not explicitly available in this document.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each performance characteristic. The precision data (intra-assay and inter-assay CVs) would typically involve multiple repetitions and samples, but the exact number of samples or runs is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information would usually be detailed in the full test report, not the summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a quantitative chemical assay like a urea test system, "ground truth" is established by the analytical measurement itself, often against certified reference materials or established methods. There are no "experts" establishing a ground truth in the sense one might find in image interpretation or diagnostic classification. The accuracy of the measurements is compared against known concentrations or a reference method.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used when human interpretation of ambiguous data is involved (e.g., pathology, radiology). For a quantitative chemical assay, the result is a numerical value, and the data is typically analyzed statistically.
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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. This is a chemical diagnostic device, not an AI-assisted diagnostic imaging or interpretation device. There are no "human readers" or "AI assistance" in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a reagent system for a chemical assay. Its performance is inherent to the chemical reactions and measurement principles. It operates "stand-alone" in the sense that its analytical results are independent of human interpretation intervention at the point of measurement, but it requires a user to perform the test.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a chemical assay, the "ground truth" for evaluating accuracy (not directly detailed in this summary but implied by the reported linearity and minimum detection limit) would typically be:
- Reference materials/standards: Samples with precisely known concentrations of urea.
- Comparison to a reference method: Testing samples also analyzed by a gold standard (e.g., isotope dilution mass spectrometry) or a well-established, validated method.
- The "expected values" provided are ranges typically found in a healthy population, not ground truth for individual test samples.
- For a chemical assay, the "ground truth" for evaluating accuracy (not directly detailed in this summary but implied by the reported linearity and minimum detection limit) would typically be:
-
The sample size for the training set:
- Not Applicable/Not Provided. This is not a machine learning or AI-based device, so the concept of a "training set" for an algorithm is not relevant. The device is a chemical reagent system.
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How the ground truth for the training set was established:
- Not Applicable. As above, no training set in the context of machine learning. The development and optimization of such a reagent system would involve extensive laboratory work and validation against known chemical principles and reference data.
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SEP 1 9 2001
Image /page/0/Picture/2 description: The image is a circular seal with the words "Wiener lab." at the top and "SISTEMA DE CALIDAD CERTIFICADO" around the bottom. In the center of the seal, there is a logo with the letters "W" inside a circle, followed by the text "ISO 9001" and the "TUV CERT" logo. The seal appears to be a certification mark, possibly indicating that Wiener lab. has been certified to meet the ISO 9001 standard.
Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" inside of a circle on the left, followed by the text "Wiener lab." in a bold, sans-serif font. Below the company name is the text "Especialidades para Laboratorios Clinicos" in a smaller font.
WIENER LABORATORIOS S.A.I.C. - Riobamba 2944 - 2000 Rosario - Argentina
Phone +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
Internet: http://www.wiener-lab.com.ar
Section 6 - Summary
510(k) Summary "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92"
リ "The assigned 510(k) number is: ±(0)22400
According to the requirements of 21 CFR 862.1770, the Introduction following information provides sufficient details to understand the basis of a determination of substantial equivalence.
Wiener Laboratorios S.A.I.C. 6-1 Submitter Riobamba 2944 Name, Address, 2000 - Rosario - Argentina Contact Tel: 54 341 4329191 Fax: 54 341 4851986 Contact person: Viviana Cétola Date Prepared: June 23, 2001
6 - 1
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| 6-2 Device Name | Proprietary name: Wiener lab. UREA UV CINETICA AACommon name: Urea test system |
|---|---|
| Classification name: Urease and Glutamic Dehydrogenase,Urea Nitrogen. | |
| Device Class II | |
| 6-3 Predicate Device | We claim substantial equivalence to the currently marketedDMA BUN-KINETIC, UREASE PROCEDURE test system (Cat.Nº 1770). |
| 6-4 Device Description | Kinetic method. |
| The device is based on the following reaction system:Urease | |
| Urea + H2O --------> 2 NH3 + CO2 | |
| NH3 + NADH + H+ + 2-oxoglutarate --------> I-glutamate + NAD++ H2O | |
| 6-5 Intended Use | The UREA UV CINETICA AA test system is intended to beused in the quantitative determination of urea in human serumand plasma. Urea measurements are used in the diagnosis andtreatment of certain renal and metabolic diseases. |
| 6-6 Equivalencies and Differences | The WIENER UREA UV CINETICA AA test system issubstantially equivalent to other products in commercialdistribution intended for similar use. Most notably it issubstantially equivalent to the currently marketed DMA BUN-KINETIC, UREASE PROCEDURE test system. |
| The following table illustrates the similarities and differencesbetween the WIENER UREA UV CINETICA AA test system andthe currently marketed DMA BUN-KINETIC, UREASEPROCEDURE test system. |
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| DMA Test System | WIENER LAB. TestSystem | |
|---|---|---|
| Intended Use | Quantitative determination of urea in humanserum and plasma. | |
| Test Principle | Kinetic method.The test is based on the following reactionsystem:UreaseUrea + H2O $\rightarrow$ 2 NH3 + CO2NH3 + NADH + H+ + 2-oxoglutarateGIDH$\rightarrow$ I-glutamate + NAD+ + H2O | |
| EssentialComponents | 2-Oxoglutarate - NADH - Urease - GIDH. | |
| Working ReagentStability | 14 days | 30 days |
| Instability ordeterioration ofreagents | Reagent BlankAbsorbance< 1.100.Precipitated or hazystandard. | Reagent BlankAbsorbance<1.000. |
| Sample | Human serum, heparinized plasmas andEDTA plasmas | |
| WorkingTemperatures | 25 - 37°C | 37°C |
| Wavelength ofreading. | 340 nm | |
| Calibration | Single point | |
| Linearity | 100 mg/dl (BUN)214 mg/dl (urea) | 140 mg/dl (BUN)300 mg/dl (urea) |
| DMA Test System | WIENER LAB. TestSystem | |
| Minimum detectionlimit | 0.4 mg/dl (BUN)0.9 mg/dl (urea) | 1.8 mg/dl (BUN)3.8 mg/dl (urea) |
| Expected values | 8 - 23 mg/dl (BUN)17 - 49 mg/dl | 4.7 - 23 mg/dl (BUN)10 - 50 mg/dl (urea) |
| Intra-assay precision | Normal SerumControl:CV = 4.3%Abnormal SerumControl:CV = 4.1% | Normal Serum Control:CV = 2.01%Abnormal SerumControl:CV = 1.19% |
| Inter-assay precision | Normal SerumControl:CV = 2.9%Abnormal SerumControl:CV = 6.1% | Normal Serum Control:CV = 2.36%Abnormal SerumControl:CV = 1.31% |
:
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6-7 Conclusion The date above mentioned show substantial equivalency to the predicate device. .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right, representing health, human services, and the public. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The seal is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Viviana Cetola QA/QC Manager Weiner Laboratories S.A.I.C. Riobamba 2944 2000 - Rosairo - Argentina
Re: K012260
Trade/Device Name: Urea UV Cinetica AA Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDQ Dated: July 4, 2001 Received: July 18, 2001
Dear Dr. Cetola:
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.
SEP 1 9 2001
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 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); 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 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and w your substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 11 you desire specific and in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, (201) 594-1500. Tradition for Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on July 1981 1999 1199 11-19 1011-free number (800) 638-2041 01 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K012260 |
|---|---|
| Device Name: | Wiener lab. |
| Urea UV.cinética AA | |
| Indications For Use: |
Page ___ of ___
FDA/CDRH/ODE/B.
JUL 18 4 32 PM '01
SK-27
The "Wiener lab. Urea UV cinética AA" urea test system is a device intended to measure urea (urea nitrogen) levels in human serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Alexander for Joan Coper
sion Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.