WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA

K013101 · Wiener Laboratories Saic · JFJ · Nov 16, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013101
• Device Name: WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA
• Applicant: Wiener Laboratories Saic
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

The AMILASA 405 CINETICA test system is intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Device Story

Amilasa 405 Cinética is an in vitro diagnostic test system for measuring amylase activity in human serum, plasma, and urine. The device uses a kinetic spectrophotometric method; the reaction involves the substrate 2-Chloro-4-Nitrophenyl-α-D-Maltotrioside (CNPG3), which is cleaved by α-amylase to produce CNP. The resulting CNP is detected spectrophotometrically at 405 nm. The test is performed in a clinical laboratory setting by trained personnel. The output is a quantitative measurement of amylase activity (U/l), which clinicians use to diagnose and monitor pancreatitis. The system consists of two reagents (R1: CNPG3 substrate; R2: MES buffer) that are mixed to form a working reagent. The device provides diagnostic information to assist in clinical decision-making regarding pancreatic health.

Clinical Evidence

Bench testing only. Performance was evaluated through comparative studies against predicate devices. Precision was assessed via intra-assay and inter-assay CVs. Intra-assay precision for normal/abnormal controls was 3.48% and 1.51% respectively; inter-assay precision was 5.53% and 1.95%. Linearity was established up to 1000 U/l. No clinical patient trials were required for this 510(k) submission.

Technological Characteristics

Kinetic spectrophotometric assay. Reagents: R1 (CNPG3 substrate) and R2 (MES buffer). Detection wavelength: 405 nm. Working temperature: 25-37°C. Linearity: up to 1000 U/l. Sample types: serum, plasma, urine. The device is an in vitro diagnostic reagent kit.

Indications for Use

Indicated for quantitative in vitro diagnostic measurement of amylase activity in serum, plasma, and urine for the diagnosis and treatment of pancreatitis in patients.

Regulatory Classification

Identification

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Predicate Devices

• GENZYME DIRECT AMYLASE test system
• TRACE AMYLASE DST test system

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a circular logo with the words "Wiener lab." at the top and "SISTEMA DE CALIDAD CERTIFICADO" around the bottom. In the center of the logo, there is a symbol that looks like a "W" above the text "ISO 9001" and the logo "TUV CERT". The logo is black and white.

NOV 1 6 2001

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 Clínicos" in a smaller 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

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: ______________________________________________________________________________________________________________________________________________

According to the requirements of 21 CFR 862.1070, the Introduction following information provides sufficient details to understand the basis of a determination of substantial equivalence.

Wiener Lab Group 6-1 Submitter Name, Address, Contact

Riobamba 2944 2000 - Rosario - Argentina

Contact person: Viviana Cétola

Date Prepared: July 05, 2001

Proprietary name: WIENER LAB. AMILASA 405 CINETICA 6-2 Device Name

Common name: Amylase test system.

Classification name: Catalytic Methods, Amylase

Device Class II

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

| <b>6-3 Predicate Device</b> | We claim substantial equivalence to the currently marketed GENZYME DIRECT AMYLASE test system for the serum / plasma application and TRACE AMYLASE DST for the urine application. |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>6-4 Device Description</b> | Kinetic method.<br>The principle is based on the following reaction system:<br>α amylase |
| | 10 CNPG ₃ → 9 CNP + 1 CNPG ₂ + G ₃ + G |
| | CNPG ₃ (2-Chloro-4-Nitrophenyl-α-D-Maltotrioside)<br>CNP can be detected spectrophotometrically at 405 nm. |
| <b>6-5 Intended Use</b> | The AMILASA 405 CINETICA test system is intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). |
| <b>6-6 Equivalencies and differences</b> | The WIENER LAB. AMILASA 405 CINETICA 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 GENZYME DIRECT AMYLASE test system for the serum / plasma application and TRACE AMYLASE DST for the urine application. |
| | The following table illustrates the similarities and differences |

The following table illustrates the similarities and differences between the WIENER LAB. AMILASA 405 CINETICA test system and the currently marketed GENZYME DIRECT AMYLASE test system. _________________________________________________________________________________________________________________________________________________________

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

:

:

| | GENZYME<br>Test System | WIENER LAB. Test<br>System |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative<br>determination of<br>amylase in human sera<br>and heparinized<br>plasmas. | Quantitative<br>determination of<br>amylase in human sera,<br>heparinized plasmas<br>and urine. |
| Test Principle | Kinetic method.<br>The principle is based on the following reaction<br>system:<br>$ \alpha \text{ amylase} \atop 10 \text{ CNPG}_3 \longrightarrow 9 \text{ CNP} + 1 \text{ CNPG}_2 + \text{G}_3 + \text{G} $ CNP can be detected spectrophotometrically<br>at 405 nm | |
| Essential<br>Components | CNPG3 (2-Chloro-4-Nitrophenyl-α-D-<br>Maltotrioside) substrate | |
| Reagents | Single reagent | R1: CNPG3 Substrate<br>R2: MES Buffer |
| Precautions and<br>Warnings | Do not pipette by mouth.<br>Avoid contamination of the reagent with salivary α<br>amylase | |
| Preparation of<br>Working Reagent | Ready to use | Dissolution of R1 with<br>R2 |
| | GENZYME<br>Test System | WIENER LAB. Test<br>System |
| Storage and<br>Stability of<br>Working Reagent | Unopened reagent is<br>stable until expiration<br>date printed on the<br>label when stored at 2-<br>8°C.<br>After opening, the<br>reagent is stable for 60<br>days when properly<br>capped immediately<br>after each opening and<br>stored at 2-8°C. | Unopened reagents are<br>stable until expiration<br>date printed on the<br>labels when stored at 2-<br>8°C.<br>After preparation the<br>reagent is stable for 15<br>days at room<br>temperature or 60 days<br>at 2-10°C. |
| Instability or<br>deterioration of<br>reagents | Reagent Blank Absorbance > 0.500.<br>Inability to recover control values.<br>Extreme turbidity. | |
| Working<br>Temperature<br>Range | 37°C | 25 - 37°C |
| Wavelength of<br>reading. | 405 nm | |
| Linearity | 2000 U/l | 1000 U/l |
| Minimum detection<br>limit | 1.0 U/l (theoretical) | 4.7 U/l (real) |
| Expected values | 25 - 94 U/l | Until 125 U/l |
| Intra-assay<br>precision | Normal Control:<br>CV = 4.6 %<br>Abnormal Control:<br>CV = 3.3 % | Normal Control:<br>CV = 3.48 %<br>Abnormal Serum<br>Control: CV = 1.51 % |
| Inter-assay<br>precision | Normal Control:<br>CV = 6.1 %<br>Abnormal Control:<br>CV = 4.2 % | Normal Control:<br>CV = 5.53 %<br>Abnormal Control:<br>CV = 1.95 % |

:

.

.

.

・・ -

and the control control control control controlled

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

。

·

:

.

.

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

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

The following table illustrates the similarities and differences between the WIENER LAB. AMILASA 405 CINETICA test system and the currently marketed TRACE AMYLASE DST test system.

| | TRACE<br>Test System | WIENER LAB. Test<br>System |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative<br>determination of<br>amylase in human sera<br>and urine | Quantitative<br>determination of<br>amylase in human sera,<br>plasma and urine. |
| Test Principle | Kinetic method. | Kinetic method. |
| | The principle is based<br>on the following<br>reaction system: | The principle is based<br>on the following<br>reaction system: |
| | $5 EpNPG_7 + 5 H_2O$ | $10 CNPG_3$ |
| | $ α amylase α glucosidase $ | $α amylase$ |
| | $5$ p-nitrophenol + $14$<br>Glucose | $9 CNP+1CNPG_2 + G_3$ +<br>Glucose |
| | pNP can be detected<br>spectrophotometrically<br>at 405 nm | CNP can be detected<br>spectrophotometrically<br>at 405 nm |
| Essential<br>Components | EpNPG7 (Ethylidene-<br>pNP-G7) substrate<br>$α$ glucosidase. | CNPG3 (2-Chloro-4-<br>Nitrophenyl- $α$ -D-<br>Maltotrioside)<br>substrate. |
| Reagents | Single reagent | R1: CNPG3 Substrate<br>R2: Buffer |
| Precautions and<br>Warnings | Do not pipette by mouth.<br>Avoid contamination of the reagent with salivary<br>$α$ amylase | |
| Continued on next page | | |
| | TRACE<br>Test System | WIENER LAB. Test<br>System |
| Preparation of<br>Working Reagent | Ready to use | Dissolution of R1 with<br>R2 |
| Storage and | Unopened reagent is<br>stable until expiration<br>date printed on the<br>label when stored at 2-<br>8°C. | Unopened reagents are<br>stable until expiration<br>date printed on the<br>labels when stored at 2-<br>8ºC. |
| Stability of<br>Working Reagent | After opening, the<br>reagent is stable until<br>expiry when properly<br>capped immediately<br>after each opening and<br>stored at 2-8°C. | After preparation the<br>reagent is stable for 15<br>days at room<br>temperature or 60 days<br>at 2-10ºC. |
| | Reagent Blank Absorbance > 0.500. | |
| Instability or<br>deterioration of | Inability to recover control values. | |
| reagents | Extreme turbidity. | |
| Sample | Human serum and urine. | Human serum, plasma<br>and urine. |
| Working<br>Temperature<br>Range | 30 / 37°C | 251301 37°C |
| Wavelength of<br>reading. | 405 nm | |
| Linearity | 2000 Ull | 1000 U/I |
| | Serum: 35 - 140 U/I<br>(37°C) | Serum: until 125 U/I<br>(37°C) |
| Expected values | Urine: 1 - 17 U/hour | Random urine: until<br>680 Ull |
| | | Continued on next page |
| | TRACE<br>Test System | WIENER LAB. Test<br>System |
| Intra-assay<br>precision | Normal Control:<br>CV = 5.3 % | Normal Control:<br>CV = 3.59 % |
| | Abnormal Control:<br>CV = 0.9 % | Abnormal Control:<br>CV = 1.49 % |
| Inter-assay<br>precision | Normal Control:<br>CV = 8.1 % | Normal Control:<br>CV = 5.53 % |
| | Abnormal Control:<br>CV = 2.6 % | Abnormal Control:<br>CV = 1.95 % |

{5}------------------------------------------------

- - - - - -

ノ・・・

: ..

:

{6}------------------------------------------------

## 6-7 Conclusion

Based on the data above mentioned, we believe that the extended claims continue to support substantial equivalence to other products in commercial distribution intended for similar use

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Viviana Cétola OC/QA Manager Wiener Laboratorios S.A.I.C. 2944 Riobamba Rosario, Santa Fe Argentina

## NOV 1 6 2001

K013101 Re:

Trade/Device Name: Wiener Lab. Amilasa 405 Cinética Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase Test System Regulatory Class: II Product Code: JFJ Dated: August 15, 2001 Received: September 17, 2001

Dear Dr. Cétola:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave love have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Amendinons, of to actives smetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include the general oonlines profision, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 renance ripply will) in the Code of Federal Regulations, Title 21, Parts 800 to 895. allecting your de roo rounded to rounder compliance with the Good Manufacturing A substantially equiral (GMP) regulation (21 CFR Part 820) and that, through I ractive for Nearear ons, the Food and Drug Administration (FDA) will verify such perfoure of inspoculonomply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the ally obtigation you inightion Control provisions, or other Federal laws or regulations.

{8}------------------------------------------------

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 1 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

{9}------------------------------------------------

CDRH ODE

K013101/

Page / of /

| 510(k) Number (if known): | K013101 |
|---------------------------|----------------------|
| Device Name: | Wiener lab. |
| | Amilasa 405 cinética |

NOV 1 6 2001

Indications For Use:

The "Wiener lab. Amilasa 405 cinética" test system is a quantitative in vitro diagnostic device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas)

Image /page/9/Picture/7 description: The image shows a document with the text "FDA/CDPR/0DE/INC" at the top. Below this, the date "SEP 17" and time "12 28 PM '01" are printed. The word "RECEIVED" is printed vertically on the left side of the image. The text appears to be a stamp or label applied to a document.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>Division S</i> |
|-------------|-------------------|
| Division of | vices |
| 510(k) Num. | K613101 |

| Prescription Use | <span style="text-decoration: overline;">X</span> |
|----------------------|---------------------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | <u></u> |
|--------------------------|---------|
| (Optional Format 1-2-96) | |

JKas