WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.

K013145 · Wiener Laboratories Saic · CIT · Nov 27, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013145
• Device Name: WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.
• Applicant: Wiener Laboratories Saic
• Product Code: CIT · Clinical Chemistry
• Decision Date: Nov 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1100
• Device Class: Class 2

Intended Use

The WIENER LAB GOT (AST) UV test system is an I.V.D. device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

Device Story

The Wiener Lab GOT (AST) UV test system is an in vitro diagnostic reagent kit for the quantitative measurement of AST/GOT levels in human serum or heparinized plasma. The assay utilizes a kinetic enzymatic method based on the conversion of L-aspartate and 2-oxoglutarate to oxaloacetate and L-glutamate, followed by the reduction of oxaloacetate to L-malate by malate dehydrogenase (MDH) with the oxidation of NADH to NAD+. The reaction is monitored spectrophotometrically at 334, 340, or 366 nm. The device is intended for use by clinical laboratory professionals to assist in the diagnosis and management of liver and heart diseases. Results are provided as enzymatic activity units (U/l), which clinicians use to assess organ function and disease progression.

Clinical Evidence

Bench testing only. Performance data includes a minimum detection limit of 1.2 U/l and linearity up to 470 U/l. Precision studies reported a within-run CV of 4.4% (normal) and 1.3% (abnormal), and total precision CV of 4.9% (normal) and 1.6% (abnormal).

Technological Characteristics

In vitro diagnostic reagent kit; kinetic enzymatic assay; utilizes L-aspartate, 2-oxoglutarate, NADH, and MDH; spectrophotometric detection at 334, 340, or 366 nm; working temperature range 25-37°C; manual or automated analyzer application.

Indications for Use

Indicated for the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma for the diagnosis and treatment of liver and heart diseases.

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

• RANDOX AST ASAT GOT OPT. test system (Cat. N° AS1204)

Submission Summary (Full Text)

{0}------------------------------------------------

GOT (AST) UV Wiener lab.

NOV 2 7 2001

Image /page/0/Picture/2 description: The image shows a logo with the letter 'W' inside a circle. To the right of the logo, the word 'Wiener' is written in a bold, sans-serif font. Below 'Wiener', the phrase 'Especialidades para' is written in a smaller font size.

Image /page/0/Picture/3 description: The image is a black and white circular logo or seal. The outer ring of the circle contains the text "Wiener lab." at the top and "SISTEMA DE CALIDAD CERTIFICADO" along the bottom. Inside the circle, there is an emblem with the text "ISO 9001" above "TÜV CERT". The TÜV CERT text is enclosed in a double-lined box. There is a small design above the ISO 9001 text.

**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

510(k) Summary "This summary of 510(K) safety and effectiveness information is being i
f This summary of 510(K) safety and effectiveness informants hary of of of of the requirements of SMDA 1990 and 21CFR 807.92"

gg "The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________

According to the requirements of 21 CFR 862.1100, the Introduction According information provides sufficient details to understand following information of substantial equivalence.

6-1 Submitter Name, Address, Contact

Wiener Lab Group Riobamba 2944 2000 - Rosario - Argentina

Contact person: Viviana Cétola

Date Prepared: February 27, 2001

Proprietary name: WIENER LAB. GOT(AST) UV 6-2 Device Name

> Common name: Aspartate amino transferase (AST/SGOT)test system.

> Classification name: NADH Oxidation / NAD Reduction, AST / SGOT

Device Class II

{1}------------------------------------------------

:

:

| 6-3 Predicate<br>Device | We claim substantial equivalence to the currently marketed<br>RANDOX AST ASAT GOT OPT. test system (Cat. N°<br>AS1204). |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-4 Device<br>Description | The principle is based on the following reaction system:<br>GOT<br>L-aspartate + 2-oxoglutarate → oxaloacetate + L-glutamate<br>MDH<br>Oxalacetate + NADH + H ⁺ → I-Malate + NAD ⁺<br>AST or GOT: Aspartate Amino transferase<br>MDH: Malate Dehydrogenase |
| 6-5 Intended<br>Use | The WIENER LAB GOT (AST) UV test system is an I.V.D.<br>device intended to be used in the quantitative determination of<br>aspartate amino transferase (AST or GOT) in human serum and<br>plasma. Aspartate amino transferase measurements are used<br>in the diagnosis and treatment of certain types of liver and heart<br>diseases. |
| 6-6<br>Equivalencies<br>and differences | The WIENER LAB. GOT (AST) UV test system is substantially<br>equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the |
| | currently marketed RANDOX AST ASAT GOT OPT test system. |

| | RANDOX<br>Test System | WIENER LAB. Test<br>System |
|------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative determination of aspartate amino<br>transferase in human serum and plasma. | |
| | | Continued on next page |
| | RANDOX<br>Test System | WIENER LAB. Test<br>System |
| | Kinetic method | The principle is based on the following reaction<br>system:<br><br>L-aspartate + 2-oxoglutarate<br><br><br><br>oxaloacetate + L-glutamate<br><br>Oxalacetate + NADH + H+<br><br><br><br>L-Malate + NAD+<br><br>AST or GOT: Aspartate Amino transferase<br>MDH: Malate Dehydrogenase |
| Test principle | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| Essential<br>Components | L-aspartate - NADH - MDH – LDH -<br>2-oxoglutarate | |
| Formula | Optimized according to IFCC | |
| Reagents | R1: L-aspartate - TRIS (Buffer)<br>R2: NADH - MDH - LDH - 2-oxoglutarate | |
| Preparation of<br>Working Reagent | Dissolution of R2 with R1 | |
| Instability or<br>deterioration of<br>reagents | Not specified | Reagent Blank<br>Absorbance <0.800 or<br>> 1.800 |
| | | Continued on next page |
| | RANDOX<br>Test System | WIENER LAB. Test<br>System |
| Sample | Human serum,<br>heparinized plasmas or<br>EDTA plasmas | Human serum or<br>heparinized plasmas |
| Working<br>Temperature Range | 25 - 30 - 37°C | |
| Wavelength of<br>reading. | 334 - 340 - 366 nm | |
| Linearity | 279 U/l | 470 U/l |
| Minimum detection<br>limit | No stated in insert | 1.2 U/l |
| Expected values | Male: until 37 U/l<br>Female: until 31 U/l<br>(37°C) | Male: until 38 U/l<br>Female: until 32 U/l<br>(37°C) |
| Within-run precision | No stated in insert | Normal Serum Control:<br>CV = 4.4%<br>Abnormal Serum<br>Control:<br>CV = 1.3% |
| Total precision | No stated in insert | Normal Serum Control:<br>CV = 4.9%<br>Abnormal Serum<br>Control:<br>CV = 1.6% |

:

:

{2}------------------------------------------------

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

:

. . . . . . .

.

:

.

.

:

{3}------------------------------------------------

్యాల్య

## 6-7 Conclusion Based on the data above mentioned, we believe that the Based on the continue to support substantial equivalence to extended claims oonlines to cappension intended for similar use

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure.

Food and Drug Àdministration 2098 Gaither Road Rockville MD 20850

NOV 2 7 2001

Dr. Viviana Cetola OC/QA Manager Weiner Laboratorios S.A.I.C. Riobamba 2944 Roasario, Santa Fe Argentina

Re: k013145

Trade/Device Name: GOT(AST) UV Regulation Number: 21 CFR 862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system Regulatory Class: Class II Product Code: CIT Dated: September 9, 2001 Received: September 20, 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 10 mos been and 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 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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 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 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}------------------------------------------------

Page_L_of_l

| 510(k) Number (if known): | K013145 |
|---------------------------|---------------|
| Device Name: | Wiener lab. |
| | GOT (ASST) UV |

Indicatious For Use:

The "Wiener lab. GOT (AST) UV" test system is an in vitro diagnostic device intended to be used in the quantitative determination of device intonusa transferase (AST or GOT) in human serum and aspartate amino transferase measurements are used in the prasma: 7 lopantato annt of certain types of liver and heart diseases.

Thomas C. Duda (acting)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013145

iseases.

SEP
12 52 PM

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBORD)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Tox 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

C.H
II

SK17