WIENER LAB GOT (AST) UV AA LIQUIDA

K023551 · Wiener Laboratories Saic · CIT · Dec 9, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023551
• Device Name: WIENER LAB GOT (AST) UV AA LIQUIDA
• Applicant: Wiener Laboratories Saic
• Product Code: CIT · Clinical Chemistry
• Decision Date: Dec 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1100
• Device Class: Class 2

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.

Device Story

In vitro diagnostic test system for quantitative determination of aspartate aminotransferase (AST/GOT) in human serum and plasma. Principle: kinetic method measuring rate of NADH disappearance via absorbance decrease at 340 nm; reaction involves L-aspartate, 2-oxoglutarate, malate dehydrogenase (MDH), and NADH. Used in clinical laboratory settings by trained personnel. Output: quantitative AST activity levels (U/l). Results assist clinicians in diagnosing and monitoring liver and heart diseases. Reagents can be used separately or as a monoreagent (4 parts buffer, 1 part substrate).

Clinical Evidence

Bench testing only. Performance evaluated via precision studies comparing subject device to predicate. Within-run precision (CV) reported as 2.41% (normal) and 1.22% (high); run-to-run precision (CV) reported as 2.26% (normal) and 2.16% (high). Linearity established up to 700 U/l.

Technological Characteristics

Kinetic enzymatic assay. Reagents: L-aspartate, 2-oxoglutarate, MDH, NADH. Wavelength: 340 nm. Linearity: 700 U/l. Form factor: liquid reagent system (monoreagent or separate). Compatible with manual and automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of aspartate aminotransferase (AST/GOT) in human serum and plasma for the diagnosis and treatment of liver and heart diseases. For use on manual and automated laboratory systems.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Wiener lab. GOT (AST) UV (Cat. N°1751302)

Submission Summary (Full Text)

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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 [phone] - Fax [phone]/5555
Internet: <http://www.wiener-lab.com.ar>

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<br>Name, Address,<br>Contact | Wiener Laboratorios S.A.I.C.<br>Riobamba 2944<br>2000 - Rosario - Argentina<br>Tel: [phone]<br>Fax: [phone]<br>Contact person: Viviana Cétola<br>Date Prepared: September 02, 2002 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-2 Device Name | Proprietary name: Wiener lab. GOT (AST) UV AA Líquida.<br>Common name: Aspartate aminotransferase (AST/SGOT) test<br>system.<br>Classification name: NADH Oxidation / NAD Reduction, AST /<br>SGOT.<br>Device Class II |

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| <b>6-3 Predicate Device</b> | We claim substantial equivalence to the currently marketed Wiener lab. GOT (AST) UV (Cat. N°1751302). |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>6-4 Device Description</b> | Kinetic Method. |
| | The principle is based on the following reaction system:<br>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.<br>MDH: Malate Dehydrogenase.<br>NADH: Nicotinamide-Adenine Dinucleotide (Reduced)<br>NAD ⁺ : Nicotinamide-Adenine Dinucleotide.<br>H ⁺ : Proton. |
| <b>6-5 Intended Use</b> | 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<br>Líquida |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative determination of Aspartate<br>Aminotransferase in human serum and plasma. | |
| Test Principle | Kinetic Method.<br><br>The principle is based on the following reaction<br>system:<br>L-aspartate + 2-oxoglutarate<br><br>GOT (AST)<br><br>Oxaloacetate + L-glutamate<br><br>Oxalacetate + NADH + H+<br><br>MDH<br><br>L-Malate + NAD+<br>The rate of disappearance of NADH and the resulting<br>decrease in absorbance at 340 nm is directly<br>proportional to the activity of GOT (AST).<br><br>AST or GOT: Aspartate Aminotransferase,MDH: Malate<br>Dehydrogenase, NADH: Nicotinamide-Adenine<br>Dinucleotide (Reduced), NAD+: Nicotinamide-Adenine<br>Dinucleotide, H+: Proton. | |
| Reagents | Buffer: L-aspartate - TRIS (buffer)<br>Substrate: NADH – MDH – LDH - 2-oxoglutarate | |
| Preparation of<br>Working Reagent | Dissolution of Reagent<br>with stated volume of<br>Buffer. | Reagents may be used<br>separately or as<br>Monoreagent, mixing 4<br>parts Buffer and 1 part<br>Substrate. |
| Wavelength of<br>Reading | 334 - 340 - 366 nm | 340 nm |
| Linearity | 470 U/l | 700 U/l |
| Expected values | Male: up to 38 U/l (37°C)<br>Female: up to 32 U/l (37°C) | |
| | | Continued on next page |
| | GOT (AST) UV | GOT (AST) UV AA<br>Líquida |
| Within-run<br>precision | Normal Level Serum:<br>CV = 4.4%<br>High Level Serum:<br>CV = 1.3% | Normal Level Serum:<br>CV = 2.41%<br>High Level Serum:<br>CV = 1.22% |
| Run-to-run<br>precision | Normal Level Serum:<br>CV = 4.9%<br>High Level Serum:<br>CV = 1.6% | Normal Level Serum:<br>CV = 2.26%<br>High Level Serum:<br>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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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 [phone]. 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 [phone] or [phone] 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

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