(48 days)
Wiener lab. GOT (AST) UV (Cat. N°1751302)
Not Found
No
The description details a standard in vitro diagnostic assay based on a kinetic enzymatic reaction and spectrophotometric measurement. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) device used for quantitative determination of an enzyme (AST) in human serum and plasma, which aids in the diagnosis and treatment of diseases but does not provide direct therapeutic intervention.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "a quantitative in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma" and that "Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases."
No
The device is an in vitro diagnostic test system that relies on chemical reactions and absorbance measurements, not solely on software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The WIENER LAB. GOT (AST) UV AA Líquida test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma..."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The WIENER LAB. GOT (AST) UV AA Líquida test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma on both manual and automated systems. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Product codes
CIT
Device Description
Kinetic Method.
The principle is based on the following reaction system:
GOT (AST)
L-aspartate + 2-oxoglutarate → Oxaloacetate + L-glutamate
MDH
Oxalacetate + NADH + H + → L-Malate + NAD +
The rate of disappearance of NADH and the resulting decrease in absorbance at 340 nm is directly proportional to the activity of GOT (AST).
AST or GOT: Aspartate Aminotransferase.
MDH: Malate Dehydrogenase.
NADH: Nicotinamide-Adenine Dinucleotide (Reduced)
NAD + : Nicotinamide-Adenine Dinucleotide.
H + : Proton.
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
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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)
Normal Level Serum: CV = 2.41%
High Level Serum: CV = 1.22%
Run-to-run precision: Normal Level Serum: CV = 2.26%, High Level Serum: CV = 2.16%
Linearity: 700 U/l
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Within-run precision: Normal Level Serum: CV = 2.41%, High Level Serum: CV = 1.22%
Run-to-run precision: Normal Level Serum: CV = 2.26%, High Level Serum: CV = 2.16%
Predicate Device(s)
Wiener lab. GOT (AST) UV (Cat. N°1751302)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(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.
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Image /page/0/Picture/1 description: The image is a circular seal or logo with the text "Wiener lab." around the top and "SISTEMA DE CALIDAD CERTIFICADO" around the bottom. In the center of the seal, there is a stylized "W" symbol above the text "ISO 9001" and "TUV" below it. 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 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, sans-serif 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: トのみるら5 / #
Introduction According to the requirements of 21 CFR 862.1100, the following information provides sufficient details to understand the basis of a determination of substantial equivalence.
| 6-1 Submitter
Name, Address,
Contact | Wiener Laboratorios S.A.I.C.
Riobamba 2944
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. GOT (AST) UV AA Líquida.
Common name: Aspartate aminotransferase (AST/SGOT) test
system.
Classification name: NADH Oxidation / NAD Reduction, AST /
SGOT.
Device Class II |
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| 6-3 Predicate Device | We claim substantial equivalence to the currently marketed Wiener lab. GOT (AST) UV (Cat. N°1751302). |
|---|---|
| 6-4 Device Description | Kinetic Method. |
| The principle is based on the following reaction system: | |
| GOT (AST) | |
| L-aspartate + 2-oxoglutarate → Oxaloacetate + L-glutamate | |
| MDH | |
| Oxalacetate + NADH + H + → L-Malate + NAD + | |
| The rate of disappearance of NADH and the resulting decrease in absorbance at 340 nm is directly proportional to the activity of GOT (AST). | |
| AST or GOT: Aspartate Aminotransferase. | |
| MDH: Malate Dehydrogenase. | |
| NADH: Nicotinamide-Adenine Dinucleotide (Reduced) | |
| NAD + : Nicotinamide-Adenine Dinucleotide. | |
| H + : Proton. | |
| 6-5 Intended Use | The WIENER LAB. GOT (AST) UV AA Líquida test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma on both manual and automated systems. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. |
- 6-6 Equivalencies The WIENER LAB. GOT (AST) UV AA Líquida test system is substantially equivalent to other products in commercial and Differences distribution intended for similar use. Most notably it is substantially equivalent to the currently WIENER LAB. GOT (AST) UV test system.
The following table illustrates the similarities and differences between the WIENER LAB. GOT (AST) UV AA Líquida test system and the currently marketed WIENER LAB. GOT (AST) UV test system.
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| | GOT (AST) UV | GOT (AST) UV AA
Líquida |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative determination of Aspartate
Aminotransferase in human serum and plasma. | |
| Test Principle | Kinetic Method.
The principle is based on the following reaction
system:
L-aspartate + 2-oxoglutarate
GOT (AST)
Oxaloacetate + L-glutamate
Oxalacetate + NADH + H+
MDH
L-Malate + NAD+
The rate of disappearance of NADH and the resulting
decrease in absorbance at 340 nm is directly
proportional to the activity of GOT (AST).
AST or GOT: Aspartate Aminotransferase,MDH: Malate
Dehydrogenase, NADH: Nicotinamide-Adenine
Dinucleotide (Reduced), NAD+: Nicotinamide-Adenine
Dinucleotide, H+: Proton. | |
| Reagents | Buffer: L-aspartate - TRIS (buffer)
Substrate: NADH – MDH – LDH - 2-oxoglutarate | |
| Preparation of
Working Reagent | Dissolution of Reagent
with stated volume of
Buffer. | Reagents may be used
separately or as
Monoreagent, mixing 4
parts Buffer and 1 part
Substrate. |
| Wavelength of
Reading | 334 - 340 - 366 nm | 340 nm |
| Linearity | 470 U/l | 700 U/l |
| Expected values | Male: up to 38 U/l (37°C)
Female: up to 32 U/l (37°C) | |
| | | Continued on next page |
| | GOT (AST) UV | GOT (AST) UV AA
Líquida |
| Within-run
precision | Normal Level Serum:
CV = 4.4%
High Level Serum:
CV = 1.3% | Normal Level Serum:
CV = 2.41%
High Level Serum:
CV = 1.22% |
| Run-to-run
precision | Normal Level Serum:
CV = 4.9%
High Level Serum:
CV = 1.6% | Normal Level Serum:
CV = 2.26%
High Level Serum:
CV = 2.16% |
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6-7 Conclusion Above mentioned data 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.
: Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Viviana Cetola OC/OA Manager Wiener Laboratorios S.A.I.C: Riobamba 2944 2000 - Rosario - Argentina
K023551 Trade/Device Name: Wiener Lab. GOT (AST) UV AA Liquida Regulation Number: 21 CFR § 862.1100 Regulation Name: NADH Oxidation/NAD Reduction, AST/SGOT Regulatory Class: II Product Code: CIT 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.
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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 Putman
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
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| 510(k) Number (if known): | K023551 |
|---|---|
| Device Name: | Wiener lab. |
| GOT (AST) UV AA LIQUIDA |
Page ___ of ___Indications For Use:
The "Wiener lab. GOT (AST) UV AA Líquida" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma on both manual and automated systems. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBOBOW
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use . (Per 21 CFR 801.109)
OR
Over-The-Counter Uso__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number -2:16
SK33
CH
II