(72 days)
Not Found
Not Found
No
The description details a standard kinetic enzymatic assay for measuring cholinesterase activity based on absorbance changes. There is no mention of AI or ML in the intended use, device description, or any other section.
No
This device is an in vitro diagnostic (IVD) device used to quantify cholinesterase levels in human specimens for diagnostic purposes, not for direct therapy.
Yes
The device is described as a "quantitative in vitro diagnostic device" and explicitly states that its measurements "are used in the diagnosis and treatment of cholinesterase inhibition disorders."
No
The device description clearly outlines a kinetic method based on chemical reactions and absorbance measurements at 405 nm, indicating a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The WIENER LAB. Colinesterasa AA test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of cholinesterase... in human specimens..."
- Nature of the Test: The device performs a test on human specimens (serum or plasma) outside of the body to provide information for diagnosis and treatment. This is the core definition of an in vitro diagnostic device.
- Purpose: The results are used "in the diagnosis and treatment of cholinesterase inhibition disorders". This directly aligns with the purpose of IVD devices.
N/A
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
DIH
Device Description
Kinetic Method. The principle is based on the following reaction system: 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. ChE: serum or plasma cholinesterase.
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
Not Found
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 = 1.41% High Level Serum: CV = 0.97%
Normal Level Serum: CV = 2.00% High Level Serum: CV = 1.97%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linearity: 17000 U/l
Within-run precision: Normal Level Serum: CV = 1.41%; High Level Serum: CV = 0.97%
Total precision: Normal Level Serum: CV = 2.00%; High Level Serum: CV = 1.97%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3240 Cholinesterase test system.
(a)
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).(b)
Classification. Class I (general 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.
0
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 +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
Internet:
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
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. Colinesterasa AA. Common name: Cholinesterase test system. Classification name: Colorimetry, Cholinesterase. Device Class I
1
| 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. |
| The principle is based on the following reaction system: | |
| 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. | |
| ChE: serum or plasma cholinesterase. | |
| 6-5 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). |
| 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. |
| 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. |
2
| 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. | |
| The principle is based on the following reaction system: | ||
| $Butyrylthiocholine + H2O \longrightarrow Thiocholine + Butyrate$ $Thiocholine + DTNB \longrightarrow 2-Nitro-5-Mercapto-benzoate$ The cholinesterase activity is determined by measuring the rate of absorbance change at 405 nm. | ||
| DTNB: 5,5'-Dithiobis-2-Nitrobenzoic Acid. | ||
| ChE: serum or plasma cholinesterase. | ||
| Reagents | Cholinesterase (BTC) | |
| Reagent: Butyrylthiocholine iodide - DTNB - Buffer. | ||
| Preparation of | ||
| 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 | ||
| 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 |
| women over 40 years old: | ||
| 5500 - 13400 U/l (37°C) | ||
| Women between 16 - 39 | ||
| years old, non pregnant | ||
| and not ingesting oral | ||
| contraceptives: 4400 - | ||
| 11700 U/l (37°C) | ||
| Women between 18 - 41 | ||
| years old, pregnant or | ||
| ingesting oral | ||
| contraceptives: 3800 - | ||
| 9500 U/l (37°C) | ||
| Within-run | ||
| precision | Normal Level Serum: | |
| CV = 2.0% | ||
| High Level Serum: | ||
| CV = 1.8% | Normal Level Serum: | |
| CV = 1.41% | ||
| High Level Serum: | ||
| CV = 0.97% | ||
| Total | ||
| precision | Normal Level Serum: | |
| CV = 4.2% | ||
| High Level Serum: | ||
| CV = 2.6% | Normal Level Serum: | |
| CV = 2.00% | ||
| High Level Serum: | ||
| CV = 1.97% |
3
のお気になる。
6-7 Conclusion Above mentioned data show substantial equivalency to the predicate device.
4
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).
5
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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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
6
CDRH ODE
| Page __ _ of____ |
|---|
| ------------------ |
| 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).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NERDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K023992 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |