(60 days)
Not Found
Not Found
No
The description details a standard kinetic enzymatic assay with spectrophotometric detection, and there are no mentions of AI, ML, or related concepts.
No
This device is an in vitro diagnostic device used to measure amylase activity for diagnostic purposes, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a quantitative in vitro diagnostic device" and that its measurements are "used primarily for the diagnosis and treatment of pancreatitis".
No
The device description clearly outlines a kinetic method based on a chemical reaction and spectrophotometric detection, indicating a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"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."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for 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).
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)
Product codes
JFJ
Device Description
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linearity: 1000 U/l
Minimum detection limit: 4.7 U/l (real)
Expected values: Until 125 U/l
Intra-assay precision: Normal Control: CV = 3.48 %, Abnormal Serum Control: CV = 1.51 %
Inter-assay precision: Normal Control: CV = 5.53 %, Abnormal Control: CV = 1.95 %
Linearity: 1000 U/I
Expected values: Serum: until 125 U/I (37°C), Random urine: until 680 U/I
Intra-assay precision: Normal Control: CV = 3.59 %, Abnormal Control: CV = 1.49 %
Inter-assay precision: Normal Control: CV = 5.53 %, Abnormal Control: CV = 1.95 %
Predicate Device(s)
Not Found. The text states "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." but no K/DEN number is provided.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
Internet:
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
| 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. _________________________________________________________________________________________________________________________________________________________
2
:
:
| | GENZYME
Test System | WIENER LAB. Test
System |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative
determination of
amylase in human sera
and heparinized
plasmas. | Quantitative
determination of
amylase in human sera,
heparinized plasmas
and urine. |
| Test Principle | Kinetic method.
The principle is based on the following reaction
system:
$ \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
at 405 nm | |
| Essential
Components | CNPG3 (2-Chloro-4-Nitrophenyl-α-D-
Maltotrioside) substrate | |
| Reagents | Single reagent | R1: CNPG3 Substrate
R2: MES Buffer |
| Precautions and
Warnings | Do not pipette by mouth.
Avoid contamination of the reagent with salivary α
amylase | |
| Preparation of
Working Reagent | Ready to use | Dissolution of R1 with
R2 |
| | GENZYME
Test System | WIENER LAB. Test
System |
| Storage and
Stability of
Working Reagent | Unopened reagent is
stable until expiration
date printed on the
label when stored at 2-
8°C.
After opening, the
reagent is stable for 60
days when properly
capped immediately
after each opening and
stored at 2-8°C. | Unopened reagents are
stable until expiration
date printed on the
labels when stored at 2-
8°C.
After preparation the
reagent is stable for 15
days at room
temperature or 60 days
at 2-10°C. |
| Instability or
deterioration of
reagents | Reagent Blank Absorbance > 0.500.
Inability to recover control values.
Extreme turbidity. | |
| Working
Temperature
Range | 37°C | 25 - 37°C |
| Wavelength of
reading. | 405 nm | |
| Linearity | 2000 U/l | 1000 U/l |
| Minimum detection
limit | 1.0 U/l (theoretical) | 4.7 U/l (real) |
| Expected values | 25 - 94 U/l | Until 125 U/l |
| Intra-assay
precision | Normal Control:
CV = 4.6 %
Abnormal Control:
CV = 3.3 % | Normal Control:
CV = 3.48 %
Abnormal Serum
Control: CV = 1.51 % |
| Inter-assay
precision | Normal Control:
CV = 6.1 %
Abnormal Control:
CV = 4.2 % | Normal Control:
CV = 5.53 %
Abnormal Control:
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
Test System | WIENER LAB. Test
System |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative
determination of
amylase in human sera
and urine | Quantitative
determination of
amylase in human sera,
plasma and urine. |
| Test Principle | Kinetic method. | Kinetic method. |
| | The principle is based
on the following
reaction system: | The principle is based
on the following
reaction 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 detected
spectrophotometrically
at 405 nm | CNP can be detected
spectrophotometrically
at 405 nm |
| Essential
Components | EpNPG7 (Ethylidene-
pNP-G7) substrate
$α$ glucosidase. | CNPG3 (2-Chloro-4-
Nitrophenyl- $α$ -D-
Maltotrioside)
substrate. |
| Reagents | Single reagent | R1: CNPG3 Substrate
R2: Buffer |
| Precautions and
Warnings | Do not pipette by mouth.
Avoid contamination of the reagent with salivary
$α$ amylase | |
| Continued on next page | | |
| | TRACE
Test System | WIENER LAB. Test
System |
| Preparation of
Working Reagent | Ready to use | Dissolution of R1 with
R2 |
| Storage and | Unopened reagent is
stable until expiration
date printed on the
label when stored at 2-
8°C. | Unopened reagents are
stable until expiration
date printed on the
labels when stored at 2-
8ºC. |
| Stability of
Working Reagent | After opening, the
reagent is stable until
expiry when properly
capped immediately
after each opening and
stored at 2-8°C. | After preparation the
reagent is stable for 15
days at room
temperature or 60 days
at 2-10ºC. |
| | Reagent Blank Absorbance > 0.500. | |
| Instability or
deterioration of | Inability to recover control values. | |
| reagents | Extreme turbidity. | |
| Sample | Human serum and urine. | Human serum, plasma
and urine. |
| Working
Temperature
Range | 30 / 37°C | 251301 37°C |
| Wavelength of
reading. | 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: until
680 Ull |
| | | Continued on next page |
| | TRACE
Test System | WIENER LAB. Test
System |
| Intra-assay
precision | Normal Control:
CV = 5.3 % | Normal Control:
CV = 3.59 % |
| | Abnormal Control:
CV = 0.9 % | Abnormal Control:
CV = 1.49 % |
| Inter-assay
precision | Normal Control:
CV = 8.1 % | Normal Control:
CV = 5.53 % |
| | Abnormal Control:
CV = 2.6 % | Abnormal Control:
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 (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
9
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