(72 days)
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).
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.
Here's a breakdown of the acceptance criteria and study information for the "Wiener lab. Colinesterasa AA" device, based on the provided text:
Device: Wiener lab. Colinesterasa AA (Cholinesterase test system)
Predicate Device: SIGMA DIAGNOSTICS Cholinesterase (BTC) (Cat. 421-10)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as separate targets, but rather are implied by direct comparison to the predicate device. The study's goal was to demonstrate "substantial equivalence" to the predicate, meaning the performance of the Wiener lab. Colinesterasa AA device should be comparable to or better than the SIGMA DIAGNOSTICS Cholinesterase (BTC) system.
| Performance Characteristic | Acceptance Criteria (Implied - comparable to predicate) | Reported Device Performance (Wiener lab. Colinesterasa AA) | Predicate Device Performance (SIGMA DIAGNOSTICS Cholinesterase (BTC)) |
|---|---|---|---|
| Intended Use | Quantitative, kinetic determination of cholinesterase activity in serum/plasma | Quantitative in vitro diagnostic for cholinesterase in human specimens (manual & automated) | Quantitative, kinetic determination of cholinesterase activity in serum |
| Test Principle | Kinetic method, absorbance change at 405 nm | Kinetic method, absorbance change at 405 nm | Kinetic method, absorbance change at 405 nm |
| Wavelength of Reading | 405 nm | 405 nm | 405 nm |
| Linearity | Comparable to 13000 U/l or better | 17000 U/l | 13000 U/l for a Sample/Reagent Ratio 1:300 |
| Within-run precision (Normal Level Serum) | Comparable to 2.0% CV or better | CV = 1.41% | CV = 2.0% |
| Within-run precision (High Level Serum) | Comparable to 1.8% CV or better | CV = 0.97% | CV = 1.8% |
| Total precision (Normal Level Serum) | Comparable to 4.2% CV or better | CV = 2.00% | CV = 4.2% |
| Total precision (High Level Serum) | Comparable to 2.6% CV or better | CV = 1.97% | CV = 2.6% |
| Expected Values | Provide relevant reference ranges | Children, men & women >40: 5500-13400 U/l (37°C); Women 16-39 (non-pregnant, non-OC): 4400-11700 U/l (37°C); Women 18-41 (pregnant or OC): 3800-9500 U/l (37°C) | 3200-7700 U/l at 30°C |
Note on Acceptance Criteria: The document explicitly states the objective is to demonstrate "substantial equivalence" to the predicate device. Therefore, the "acceptance criteria" are implied to be achieving comparable or improved performance across the listed metrics. The reported device performance generally demonstrates better performance (e.g., higher linearity, lower CVs for precision) than the predicate device, which supports the claim of substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size for the test set used to generate the reported performance data (linearity, precision, expected values).
The data provenance is not explicitly stated. However, given that "Wiener Laboratorios S.A.I.C." is located in Rosario, Argentina, it is reasonable to infer that the studies were likely conducted in Argentina or involved samples from that region. The study type (retrospective or prospective) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of in vitro diagnostic device for chemical analysis. Ground truth for enzyme activity measurements is established through the analytical performance of the device (e.g., linearity, precision, accuracy against known standards or validated methods), not through expert consensus on qualitative interpretation. The "ground truth" here is the actual cholinesterase activity in the samples, measured by the device and compared for consistency and accuracy.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used for qualitative or interpretive assessments (e.g., diagnostic imaging, pathology slides) where there might be inter-reader variability. This is not applicable to the quantitative measurement of an enzyme activity by an in vitro diagnostic device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. The device is an in vitro diagnostic for quantitative chemical analysis, not an AI-powered diagnostic imaging or qualitative assessment tool that involves human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable in the context of an "algorithm only" device as typically understood for AI or image analysis. The "Wiener lab. Colinesterasa AA" system is a chemical reagent-based assay. Its performance is inherent to the chemical reactions and subsequent spectrophotometric measurement, whether operated manually or on an automated system. Its operation is analogous to a standalone diagnostic test in that the result is directly generated by the system, requiring human intervention primarily for sample handling, instrument setup, and interpretation of the numerical result against reference ranges.
7. The Type of Ground Truth Used
The ground truth used for performance validation (linearity, precision, expected values) would typically be:
- For Linearity: Known concentrations of cholinesterase, or samples whose concentrations have been established by a gold-standard reference method.
- For Precision: Repeated measurements on control materials or patient samples where consistent readings are expected.
- For Expected Values: Data collected from a statistically significant healthy population (reference ranges) as well as patient populations with known cholinesterase inhibition disorders. The provided "Expected values" table serves as a reference range established through clinical studies.
8. The Sample Size for the Training Set
This is not applicable as the device is a chemical reagent-based analytical system, not a machine learning model that requires a "training set" in the conventional sense. The "training" for such a system involves formulation optimization and calibration, which doesn't typically involve a "training set" of patient data as understood in AI/ML.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
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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 +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
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 SubmitterName, 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
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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.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. |
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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.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 ofWorking 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 ofReading | 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 andwomen over 40 years old:5500 - 13400 U/l (37°C)Women between 16 - 39years old, non pregnantand not ingesting oralcontraceptives: 4400 -11700 U/l (37°C)Women between 18 - 41years old, pregnant oringesting oralcontraceptives: 3800 -9500 U/l (37°C) |
| Within-runprecision | Normal Level Serum:CV = 2.0%High Level Serum:CV = 1.8% | Normal Level Serum:CV = 1.41%High Level Serum:CV = 0.97% |
| Totalprecision | Normal Level Serum:CV = 4.2%High Level Serum:CV = 2.6% | Normal Level Serum:CV = 2.00%High Level Serum: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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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
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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).
(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) |
§ 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.