(63 days)
DMA BUN-KINETIC, UREASE PROCEDURE test system (Cat. Nº 1770)
Not Found
No
The device description outlines a standard kinetic enzymatic assay for urea, and there are no mentions of AI, ML, image processing, or data-driven algorithms in the provided text.
No
The device is used for in-vitro diagnostic (IVD) quantitative determination of urea in human serum and plasma, which aids in the diagnosis and treatment of diseases, rather than providing direct therapeutic treatment.
Yes
The "Intended Use / Indications for Use" states that "Urea measurements are used in the diagnosis and treatment of certain renal and metabolic diseases." This indicates that the device aids in diagnosis.
No
The device description outlines a chemical reaction system involving enzymes and reagents, indicating a hardware component (likely a laboratory analyzer) is required to perform the test. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of urea in human serum and plasma." This is a classic example of an in vitro diagnostic test, as it analyzes biological samples (serum and plasma) outside of the body to provide information for diagnosis and treatment.
- Device Description: The description details a "Kinetic method" based on specific chemical reactions involving enzymes (Urease) and reagents to measure urea levels. This is the methodology of an in vitro diagnostic assay.
- Performance Studies: The document includes performance characteristics like linearity, detection limit, expected values, and precision, which are standard metrics for evaluating the performance of an IVD test.
- Predicate Device: The mention of a "Predicate Device" (DMA BUN-KINETIC, UREASE PROCEDURE test system) is common in regulatory submissions for IVDs, where a new device is compared to an already approved device.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CDQ
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
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
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Working Reagent Stability: 30 days
Reagent Blank Absorbance:
§ 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.
0
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:
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
1
| 6-2 Device Name | Proprietary name: Wiener lab. UREA UV CINETICA AA
Common 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 marketed
DMA 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 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. |
| 6-6 Equivalencies and Differences | The WIENER UREA UV CINETICA AA test system is
substantially equivalent to other products in commercial
distribution intended for similar use. Most notably it is
substantially equivalent to the currently marketed DMA BUN-
KINETIC, UREASE PROCEDURE test system. |
| | The following table illustrates the similarities and differences
between the WIENER UREA UV CINETICA AA test system and
the currently marketed DMA BUN-KINETIC, UREASE
PROCEDURE test system. |
1
2
、
| | DMA Test System | WIENER LAB. Test
System |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use | Quantitative determination of urea in human
serum and plasma. | |
| Test Principle | Kinetic method.
The test is based on the following reaction
system:
Urease
Urea + H2O $\rightarrow$ 2 NH3 + CO2
NH3 + NADH + H+ + 2-oxoglutarate
GIDH
$\rightarrow$ I-glutamate + NAD+ + H2O | |
| Essential
Components | 2-Oxoglutarate - NADH - Urease - GIDH. | |
| Working Reagent
Stability | 14 days | 30 days |
| Instability or
deterioration of
reagents | Reagent Blank
Absorbance
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.
5
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
6
| 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)