WIENER LAB COLINESTERASA AA

K023992 · Wiener Laboratories Saic · DIH · Feb 12, 2003 · Clinical Toxicology

Device Facts

• Record ID: K023992
• Device Name: WIENER LAB COLINESTERASA AA
• Applicant: Wiener Laboratories Saic
• Product Code: DIH · Clinical Toxicology
• Decision Date: Feb 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3240
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The WIENER LAB. Colinesterasa AA test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens, on both manual and automated systems. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

Device Story

The Wiener lab. Colinesterasa AA is an in vitro diagnostic test system for measuring cholinesterase activity in human serum or plasma. The device uses a kinetic colorimetric method; butyrylthiocholine is hydrolyzed by cholinesterase to produce thiocholine, which then reacts with 5,5'-Dithiobis-2-Nitrobenzoic Acid (DTNB) to form 2-Nitro-5-Mercapto-benzoate. The rate of absorbance change is measured at 405 nm. The system is intended for use in clinical laboratories on manual or automated platforms by trained laboratory personnel. Results are used by clinicians to diagnose and manage cholinesterase inhibition, including poisoning from insecticides or succinylcholine. The device provides quantitative enzyme activity levels, assisting in the assessment of patient exposure or metabolic status.

Clinical Evidence

Bench testing only. Performance was evaluated through precision studies comparing the subject device to the predicate. Within-run precision (CV) was 1.41% (normal) and 0.97% (high), and total precision (CV) was 2.00% (normal) and 1.97% (high). Linearity was established up to 17000 U/l.

Technological Characteristics

Kinetic colorimetric assay. Reagents include Butyrylthiocholine, DTNB, and buffer. Measurement via spectrophotometry at 405 nm. Compatible with manual and automated clinical laboratory systems. No specific materials of construction or software architecture specified beyond standard laboratory reagent chemistry.

Indications for Use

Indicated for the quantitative determination of cholinesterase in human serum or plasma to aid in the diagnosis and treatment of cholinesterase inhibition disorders, such as insecticide or succinylcholine poisoning. Applicable to patients of all ages.

Regulatory Classification

Identification

A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

Predicate Devices

• SIGMA DIAGNOSTICS Cholinesterase (BTC) (Cat. 421-10)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a circular seal with the words "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 "ISO 9001" above the letters "TUV CERT". The seal appears to be a certification mark, possibly indicating that the organization has met certain quality standards.

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

Section 6 - Summary

FEB 1 2 2003

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: _ KOA 399 2

According to the requirements of 21 CFR 862.3240, the following Introduction 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. |
|--------------------------------------------|-----------------------------------|
| | Riobamba 2944 |
| | 2000 - Rosario - Argentina |
| | Tel: [phone] |
| | Fax: [phone] |
| | Contact person: Viviana Cétola |
| | Date Prepared: September 02, 2002 |

6-2 Device Name Proprietary name: Wiener lab. Colinesterasa AA. Common name: Cholinesterase test system. Classification name: Colorimetry, Cholinesterase. Device Class I

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| 6-3 Predicate Device | We claim substantial equivalence to the currently marketed SIGMA DIAGNOSTICS Cholinesterase (BTC) (Cat. 421-10). |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6-4 Device Description | Kinetic Method.<br>The principle is based on the following reaction system:<br>Cholinesterase |
| | Butyrylthiocholine + H2O -> Thiocholine + Butyrate |
| | Thiocholine + DTNB -> 2-Nitro-5-Mercapto-benzoate |
| | The cholinesterase activity is determined by measuring the rate of absorbance change at 405 nm. |
| | DTNB: 5,5'-Dithiobis-2-Nitrobenzoic Acid.<br>ChE: serum or plasma cholinesterase. |
| 6-5 Intended Use | The WIENER LAB. Colinesterasa AA test system is a quantitative <i>in vitro</i> diagnostic device intended to be used in the quantitative determination of cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens, on both manual and automated systems. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning). |
| 6-6 Equivalencies and Differences | The WIENER LAB. Colinesterasa AA 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 SIGMA DIAGNOSTICS Cholinesterase (BTC) test system.<br>The following table illustrates the similarities and differences between the WIENER LAB. Colinesterasa AA test system and the currently marketed SIGMA DIAGNOSTICS Cholinesterase (BTC) test system. |

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| | Cholinesterase (BTC) | Colinesterasa AA |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the quantitative, kinetic determination of cholinesterase activity in serum at 405 nm. | Kinetic method at 405 nm for the determination of cholinesterase in serum or plasma. |
| Test Principle | Kinetic Method.<br>The principle is based on the following reaction system:<br>$Butyrylthiocholine + H2O \longrightarrow Thiocholine + Butyrate$ $Thiocholine + DTNB \longrightarrow 2-Nitro-5-Mercapto-benzoate$ The cholinesterase activity is determined by measuring the rate of absorbance change at 405 nm.<br>DTNB: 5,5'-Dithiobis-2-Nitrobenzoic Acid.<br>ChE: serum or plasma cholinesterase. | |
| | Reagents | Cholinesterase (BTC)<br>Reagent: Butyrylthiocholine iodide - DTNB - Buffer. |
| Preparation of<br>Working Reagent | Reconstitute Cholinesterase (BTC) Reagent with indicated volume of deionized water | Reconstitute each Reagent 1 and 2 vial with stated volume of Diluent 1 and 2 respectively. |
| Wavelength of<br>Reading | 405 nm | |
| Linearity | 13000 U/l for a Sample/Reagent Ratio 1:300 | 17000 U/l |
| | | Continued on next page |
| | Cholinesterase (BTC) | Colinesterasa AA |
| Expected values | 3200 - 7700 U/l at 30°C | Children, men and<br>women over 40 years old:<br>5500 - 13400 U/l (37°C)<br>Women between 16 - 39<br>years old, non pregnant<br>and not ingesting oral<br>contraceptives: 4400 -<br>11700 U/l (37°C)<br>Women between 18 - 41<br>years old, pregnant or<br>ingesting oral<br>contraceptives: 3800 -<br>9500 U/l (37°C) |
| Within-run<br>precision | Normal Level Serum:<br>CV = 2.0%<br>High Level Serum:<br>CV = 1.8% | Normal Level Serum:<br>CV = 1.41%<br>High Level Serum:<br>CV = 0.97% |
| Total<br>precision | Normal Level Serum:<br>CV = 4.2%<br>High Level Serum:<br>CV = 2.6% | Normal Level Serum:<br>CV = 2.00%<br>High Level Serum:<br>CV = 1.97% |

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のお気になる。

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged around the top half of the circle. The logo is black and white.

Public Health Service

FEB 1 2 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Viviana Cetola QC/QA Manager Weiner Laboratorios S.A.I.C. Riobamba 2944 Rosario. Santa Fe Argentina 2000

k023992 Re:

Trade/Device Name: Wiener Lab. Colinesterasa AA Regulation Number: 21 CFR 862.3240 Regulation Name: Cholinesterase test system Regulatory Class: Class I Product Code: DIH Dated: January 20, 2003 Received: January 22, 2003

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 (OS) regulation (21 CFR Part 820).

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Page 2 -

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.

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). You may obtain other general information on your responsibilities under the Act 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclósure

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CDRH ODE

| Page __ _ of____ |
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| 510(k) Number (if known): | K023992 |
|---------------------------|------------------|
| Device Name: | Wiener lab. |
| | Colinesterasa AA |

## Indications For Usc:

The "Wiener lab. Colinesterasa AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human serum or plasma, on both manual and automated systems. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K023992 |

| Prescription Use | <img alt="check mark" src="check_mark.jpg"/> | OR | Over-The-Counter Use |
|----------------------|----------------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | | |