(48 days)
1840106
Not Found
No
The device description outlines a standard enzymatic assay for measuring uric acid, and there are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an in vitro diagnostic device used for the determination of uric acid, which is used in diagnosis and treatment, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "quantitative in vitro diagnostic device" and describes its use in the "diagnosis and treatment of numerous renal and metabolic disorders."
No
The device description clearly outlines a chemical reaction system involving reagents (Uricase, Peroxidase, etc.) and the measurement of absorbance, indicating a physical in vitro diagnostic test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Wiener lab. Uricostat enzimático AA Líquida. test system is a quantitative in vitro diagnostic device intended to be used in the determination of uric acid in human sera and heparinized plasmas on both manual and automated systems."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Wiener lab. Uricostat enzimático AA Líquida. test system is a quantitative in vitro diagnostic device intended to be used in the determination of uric acid in human sera and heparinized plasmas on both manual and automated systems. Measurements of serum uric acid, are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients under treatment with cytotoxic drugs.
Product codes
KNK
Device Description
End point method.
The principle is based on the following reaction system:
UOD
Uric Acid + 2 H2O + O2-
-> Allantoin + H2O2 + CO2
POD
2 H2O2 + 4-AP + 3,5-SDH ------------------------------------------------------------------------------------------------------------------------------------------------------
The amount of uric acid is determined by measuring the
absorbance of this pigment.
UOD: Uricase; POD: Peroxidase; 4-AP: 4-Aminophenazone;
3,5-DHS: 3,5-dichlorohydroxybenzenesulfonic acid, sodium salt.
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
Not Found
Key Metrics
Within-run precision
Normal Control:
CV = 1.75%
Abnormal Control:
CV = 1.78%
Normal Level Serum:
CV = 2.21%
High Level Serum:
CV = 1.32%
Run-to-run precision
Normal Control:
CV = 2.61%
Abnormal Control:
CV = 2.39%
Normal Level Serum:
CV = 2.86%
High Level Serum:
CV = 1.90%
Predicate Device(s)
Wiener lab. Uricostat enzimático AA test system (Cat. Nº 1840106).
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1775 Uric acid test system.
(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image is a circular seal with the text "Wiener lab." at the top and "Sistema de Calidad Certificado" at 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 logo of "TUV". The seal appears to be a certification mark, possibly indicating that Wiener lab. has a quality management system certified to ISO 9001 standards by TUV.
Image /page/0/Picture/2 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" inside a circle on the left, followed by the text "Wiener lab." in a bold, sans-serif font. Below the company name, there is the text "Especialidades para Laboratorios Clínicos" 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
DEC 0 9 2002
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"
"The assigned 510(k) number is: »
Introduction
According to the requirements of 21 CFR 862.1775, the following information provides sufficient details to understand the basis of a determination of substantial equivalence.
Wiener Laboratorios S.A.I.C. 6-1 Submitter Name, Address, Riobamba 2944 Contact 2000 - Rosario - Argentina Tel: 54 341 4329191 Fax: 54 341 4851986 Contact person: Viviana Cétola Date Prepared: September 02, 2002
6-2 Device Name Proprietary name: Wiener lab. Uricostat enzimático AA Líquida. Common name: Uric acid test system Classification name: Acid, uric, uricase (colorimetric) Device Class I
1
| 6-3 Predicate
Device | We claim substantial equivalence to the currently marketed
Wiener lab. Uricostat enzimático AA test system (Cat. Nº
1840106). | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| 6-4 Device
Description | End point method. | |
| | The principle is based on the following reaction system: | |
| | UOD
Uric Acid + 2 H2O + O2-
-> Allantoin + H2O2 + CO2
POD
2 H2O2 + 4-AP + 3,5-SDH ------------------------------------------------------------------------------------------------------------------------------------------------------
The amount of uric acid is determined by measuring the
absorbance of this pigment.
UOD: Uricase; POD: Peroxidase; 4-AP: 4-Aminophenazone; | |
| | 3,5-DHS: 3,5-dichlorohydroxybenzenesulfonic acid, sodium salt. | |
| 6-5 Intended Use | The Wiener lab. Uricostat enzimático AA Líquida. test system is
a quantitative in vitro diagnostic device intended to be used in
the determination of uric acid in human sera and heparinized
plasmas on both manual and automated systems.
Measurements of serum uric acid, are used in the diagnosis
and treatment of numerous renal and metabolic disorders,
including renal failure, gout, leukemia, psoriasis, starvation or
other wasting conditions and of patients under treatment with
cytotoxic drugs. | |
| and Differences | 6-6 Equivalencies The Uricostat enzimático AA Líquida 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 Uricostat enzimático AA test system.
The following table illustrates the similarities and differences
between the Uricostat enzimático AA Líquida test system and
the currently marketed Uricostat enzimático AA test system. | |
| | Uricostat enzimático
AA | Uricostat enzimático
AA Líquida |
| Intended Use | Enzymatic method for
the determination of uric
acid in serum or urine. | Enzymatic method for
the determination of uric
acid in serum or plasma. |
| Test Principle | End point method.
The analytical system is based on the following
reaction:
$Uric Acid + 2 H2O + O2$
UOD
$Allantoin + H2O2 + CO2$
$2 H2O2 + 4-AP + 3,5-DHS$
POD
red quinonimine
The amount of uric acid is determined by measuring
the absorbance of this pigment.
UOD: Uricase; POD: Peroxidase; 4-AP: 4-Aminophenazone;
3,5-DHS: 3,5-dichlorohydroxybenzenesulfonic acid, sodium salt. | |
| Reagents | Standard: uric acid.
Buffer: phosphates
buffer.
Enzymes: UOD – POD –
DHS – 4-AP –
Potassium Ferrocyanide. | Standard: uric acid.
Reagent 1: Good buffer -
DHS.
Reagent 2: Good buffer -
|
| Preparation of
Working Reagent | Dissolution of an Enzyme
vial in a Buffer bottle. | Reagents may be used
separately or as
Monoreagent, mixing 4
parts of Reagent 1 + 1
part of Reagent 2. |
| Continued on next page | | |
| | Uricostat enzimático
AA | Uricostat enzimático
AA Líquida |
| Stability of Final
Color | 30 minutes. | |
| Wavelength of
Reading | 505 nm in spectrophotometer or 490-530 nm in
photocolorimeter with green filter. | |
| Calibration | Single point. | |
| Linearity | 20 mg/dl | |
| Within-run
precision | Normal Control:
CV = 1.75%
Abnormal Control:
CV = 1.78% | Normal Level Serum:
CV = 2.21%
High Level Serum:
CV = 1.32% |
| Run-to-run
precision | Normal Control:
CV = 2.61%
Abnormal Control:
CV = 2.39% | Normal Level Serum:
CV = 2.86%
High Level Serum:
CV = 1.90% |
2
3
6-7 Conclusion Above mentioned data show substantial equivalency to the predicate device.
4
| Page__________________________________________________________________________________________________________________________________________________________________________ | |
|---|---|
| of_ | |
| 510(k) Number (if known): | K023550 |
|---|---|
| Device Name: | Wiener lab. |
| URICOSTAT: ENZIMÁTICO AA LÍQUIDA |
Indications For Use:
The "Wiener lab. Uricostat enzimático AA Líquida" test system is a quantitative in vitro diagnostic device intended to be used in the determination of uric acid in human sera and heparinized plasmas on both manual and automated systems. Measurements of serum uric acid are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients under treatment with cytotoxic drugs.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGB IF NBBDBD
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines above it.
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Dr. Viviana Cetola . QC/QA Manager Wiener Laboratorios S.A.I.C. Riobamba 2944 2000 - Rosario - Argentina
K023550 Re:
Trade/Device Name: Wiener Lab. Uricostat enzimatico AA Liquida Regulation Number: 21 CFR § 862.1775 Regulation Name: Uric Acid, Uricase (Colorimetric) Regulatory Class: I Product Code: KNK Dated: September 13, 2002 Received: October 22, 2002
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.
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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.
6
Page 2
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
| 510(k) Number (if known): | K033550 |
|---|---|
| Device Name: | Wiener lab. |
| URICOSTAT: ENZIMÁTICO AA LIQUIDA |
Indications For Use:
The "Wiener lab. Uricostat enzimático AA Líquida" test system is a quantitative in vitro diagnostic device intended to be used in the, determination of uric acid in human sera and heparinized plasmas on both manual and automated systems. Measurements of serum uric acid are used in the diagnosis and treatment of numerous renal and , metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients under treatment. with cytotoxic drugs.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER. PAGB IF NBBOBD)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)
Zion & Eph
OR
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .