(60 days)
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)
Kinetic method. The principle is based on the following reaction system: alpha amylase 10 CNPG 3 -> 9 CNP + 1 CNPG 2 + G 3 + G CNPG 3 (2-Chloro-4-Nitrophenyl-alpha-D-Maltotrioside) CNP can be detected spectrophotometrically at 405 nm.
The provided text does not contain detailed acceptance criteria for the "Wiener Lab. Amilasa 405 Cinética" test system. It presents performance characteristics of the Wiener Lab. system and compares them to two predicate devices (GENZYME DIRECT AMYLASE and TRACE AMYLASE DST).
However, I can extract the reported performance characteristics of the Wiener Lab. device that would typically be part of acceptance criteria for such a device, and detail the lack of information regarding the study design and acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Not explicitly stated, but typical for medical devices) | Reported Wiener Lab. AMILASA 405 CINETICA Performance |
|---|---|---|
| Intended Use | Quantitative determination of amylase in human sera, plasma, and urine for diagnosis and treatment of pancreatitis. | Quantitative determination of amylase in human sera, plasma, and urine for diagnosis and treatment of pancreatitis. |
| Test Principle | Kinetic method based on specific enzymatic reaction and spectrophotometric detection at 405 nm. | Kinetic method using CNPG3 substrate, detected spectrophotometrically at 405 nm. |
| Reagent Stability | Unopened: Stable until expiration date at 2-8°C. Prepared: Stable for specified duration at given temperature. | Unopened: Stable until expiration date at 2-8°C. Prepared: 15 days at room temperature or 60 days at 2-10°C. |
| Working Temperature Range | Defined operating temperature(s). | 25 - 37°C |
| Wavelength of Reading | 405 nm | 405 nm |
| Linearity | Defined range where results are proportional to concentration. | 1000 U/l |
| Minimum Detection Limit | Lowest concentration detectable with reasonable analytical precision. | 4.7 U/l (real) |
| Expected Values (Serum) | Reference range for healthy individuals. | Until 125 U/l (at 37°C) |
| Expected Values (Urine) | Reference range for healthy individuals. | Until 680 U/l (Random urine) |
| Intra-assay Precision (Normal Control) | Acceptable Coefficient of Variation (CV). | CV = 3.48 % |
| Intra-assay Precision (Abnormal Control) | Acceptable Coefficient of Variation (CV). | CV = 1.51 % |
| Inter-assay Precision (Normal Control) | Acceptable Coefficient of Variation (CV). | CV = 5.53 % |
| Inter-assay Precision (Abnormal Control) | Acceptable Coefficient of Variation (CV). | CV = 1.95 % |
Note: The document states "The following table illustrates the similarities and differences" when comparing the new device to predicate devices. It presents characteristics and their values for both devices, implying these are the performance metrics assessed for substantial equivalence. However, explicit numerical acceptance criteria (e.g., "Linearity must be >= 1000 U/l") are not provided, nor is a direct statement like "The device meets the following acceptance criteria: ...". The "reported device performance" in the table above is the "WIENER LAB. Test System" column from the provided tables.
2. Sample size used for the test set and the data provenance
The document does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information about experts used for ground truth or their qualifications. The device is an in vitro diagnostic (IVD) test, where ground truth is typically established through reference methods or clinical diagnosis, not expert image interpretation.
4. Adjudication method for the test set
The document does not provide any information about an adjudication method for a test set. This concept is usually relevant for studies involving human interpretation (e.g., radiology reads), which is not the primary focus for an IVD kit's performance evaluation as described here.
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 section is not applicable as the document describes an in vitro diagnostic test for amylase activity, not an AI-assisted diagnostic tool that involves human readers interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document describes the performance of the device itself as a standalone diagnostic test. It does not refer to an "algorithm" in the context of AI, but rather the chemical reagents and kinetic method. The performance characteristics listed (precision, linearity, detection limit, expected values) are indeed standalone performance metrics for this IVD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used to evaluate the device's performance characteristics. For an amylase assay, ground truth during development and validation would typically involve:
- Reference methods: Comparing results to established, highly accurate (though often more complex or expensive) amylase measurement methods.
- Known concentration samples: Using samples with accurately determined amylase concentrations (e.g., spiked samples, commutable reference materials).
- Clinically characterized samples: Samples from patients with confirmed pancreatitis or healthy individuals, where the clinical diagnosis serves as the 'truth' regarding the expected range or elevated levels.
8. The sample size for the training set
The document does not provide any information about a "training set." This term is typically used in machine learning or AI development. For an IVD device like this, the equivalent would be the samples used during the development and optimization phases. No sample sizes for these phases are reported.
9. How the ground truth for the training set was established
As there is no mention of a training set, there is no information on how its ground truth was established.
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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 +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
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
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| 6-3 Predicate Device | 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. |
|---|---|
| 6-4 Device Description | Kinetic method.The principle is based on the following reaction system:α amylase |
| 10 CNPG 3 → 9 CNP + 1 CNPG 2 + G 3 + G | |
| CNPG 3 (2-Chloro-4-Nitrophenyl-α-D-Maltotrioside)CNP can be detected spectrophotometrically at 405 nm. | |
| 6-5 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). |
| 6-6 Equivalencies and differences | 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. _________________________________________________________________________________________________________________________________________________________
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| GENZYMETest System | WIENER LAB. TestSystem | |
|---|---|---|
| Intended Use | Quantitativedetermination ofamylase in human seraand heparinizedplasmas. | Quantitativedetermination ofamylase in human sera,heparinized plasmasand urine. |
| Test Principle | Kinetic method.The principle is based on the following reactionsystem:$ \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 spectrophotometricallyat 405 nm | |
| EssentialComponents | CNPG3 (2-Chloro-4-Nitrophenyl-α-D-Maltotrioside) substrate | |
| Reagents | Single reagent | R1: CNPG3 SubstrateR2: MES Buffer |
| Precautions andWarnings | Do not pipette by mouth.Avoid contamination of the reagent with salivary αamylase | |
| Preparation ofWorking Reagent | Ready to use | Dissolution of R1 withR2 |
| GENZYMETest System | WIENER LAB. TestSystem | |
| Storage andStability ofWorking Reagent | Unopened reagent isstable until expirationdate printed on thelabel when stored at 2-8°C.After opening, thereagent is stable for 60days when properlycapped immediatelyafter each opening andstored at 2-8°C. | Unopened reagents arestable until expirationdate printed on thelabels when stored at 2-8°C.After preparation thereagent is stable for 15days at roomtemperature or 60 daysat 2-10°C. |
| Instability ordeterioration ofreagents | Reagent Blank Absorbance > 0.500.Inability to recover control values.Extreme turbidity. | |
| WorkingTemperatureRange | 37°C | 25 - 37°C |
| Wavelength ofreading. | 405 nm | |
| Linearity | 2000 U/l | 1000 U/l |
| Minimum detectionlimit | 1.0 U/l (theoretical) | 4.7 U/l (real) |
| Expected values | 25 - 94 U/l | Until 125 U/l |
| Intra-assayprecision | Normal Control:CV = 4.6 %Abnormal Control:CV = 3.3 % | Normal Control:CV = 3.48 %Abnormal SerumControl: CV = 1.51 % |
| Inter-assayprecision | Normal Control:CV = 6.1 %Abnormal Control:CV = 4.2 % | Normal Control:CV = 5.53 %Abnormal Control:CV = 1.95 % |
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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.
| TRACETest System | WIENER LAB. TestSystem | |
|---|---|---|
| Intended Use | Quantitativedetermination ofamylase in human seraand urine | Quantitativedetermination ofamylase in human sera,plasma and urine. |
| Test Principle | Kinetic method. | Kinetic method. |
| The principle is basedon the followingreaction system: | The principle is basedon the followingreaction system: | |
| $5 EpNPG_7 + 5 H_2O$ | $10 CNPG_3$ | |
| $ α amylase α glucosidase $ | $α amylase$ | |
| $5$ p-nitrophenol + $14$Glucose | $9 CNP+1CNPG_2 + G_3$ +Glucose | |
| pNP can be detectedspectrophotometricallyat 405 nm | CNP can be detectedspectrophotometricallyat 405 nm | |
| EssentialComponents | EpNPG7 (Ethylidene-pNP-G7) substrate$α$ glucosidase. | CNPG3 (2-Chloro-4-Nitrophenyl- $α$ -D-Maltotrioside)substrate. |
| Reagents | Single reagent | R1: CNPG3 SubstrateR2: Buffer |
| Precautions andWarnings | Do not pipette by mouth.Avoid contamination of the reagent with salivary$α$ amylase | |
| Continued on next page | ||
| TRACETest System | WIENER LAB. TestSystem | |
| Preparation ofWorking Reagent | Ready to use | Dissolution of R1 withR2 |
| Storage and | Unopened reagent isstable until expirationdate printed on thelabel when stored at 2-8°C. | Unopened reagents arestable until expirationdate printed on thelabels when stored at 2-8ºC. |
| Stability ofWorking Reagent | After opening, thereagent is stable untilexpiry when properlycapped immediatelyafter each opening andstored at 2-8°C. | After preparation thereagent is stable for 15days at roomtemperature or 60 daysat 2-10ºC. |
| Reagent Blank Absorbance > 0.500. | ||
| Instability ordeterioration of | Inability to recover control values. | |
| reagents | Extreme turbidity. | |
| Sample | Human serum and urine. | Human serum, plasmaand urine. |
| WorkingTemperatureRange | 30 / 37°C | 251301 37°C |
| Wavelength ofreading. | 405 nm | |
| Linearity | 2000 Ull | 1000 U/I |
| Serum: 35 - 140 U/I(37°C) | Serum: until 125 U/I(37°C) | |
| Expected values | Urine: 1 - 17 U/hour | Random urine: until680 Ull |
| Continued on next page | ||
| TRACETest System | WIENER LAB. TestSystem | |
| Intra-assayprecision | Normal Control:CV = 5.3 % | Normal Control:CV = 3.59 % |
| Abnormal Control:CV = 0.9 % | Abnormal Control:CV = 1.49 % | |
| Inter-assayprecision | Normal Control:CV = 8.1 % | Normal Control:CV = 5.53 % |
| Abnormal Control:CV = 2.6 % | Abnormal Control:CV = 1.95 % |
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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
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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.
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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. 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 (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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CDRH ODE
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)
| Division S | |
|---|---|
| Division of | vices |
| 510(k) Num. | K613101 |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
JKas
§ 862.1070 Amylase test system.
(a)
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).(b)
Classification. Class II.