(100 days)
RANDOX CREATININE (Cat. Nº CR510), DMA CREATININE (Cat. Nº 1430)
Not Found
No
The description details a standard chemical reaction-based assay for measuring creatinine levels, with no mention of AI or ML technologies.
No
This device is a diagnostic test system used to measure creatinine levels, which aids in the diagnosis and monitoring of renal diseases. It does not directly treat or alleviate a disease or condition in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Creatinine measurements are used in the diagnosis and treatment of renal diseases." This indicates its role in identifying or confirming medical conditions.
No
The device description clearly describes a chemical assay that measures creatinine levels through a reaction and absorbance measurement, indicating it is a physical test system, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure creatinine levels in human serum, plasma and urine." It also mentions that these measurements are "used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as calculation basis for measuring other urine analytes." This clearly indicates that the device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a chemical reaction that occurs with a human sample (creatinine in the sample reacts with picrate). This is a characteristic of an in vitro diagnostic test.
The definition of an IVD generally involves devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. This device fits that definition.
N/A
Intended Use / Indications for Use
The CREATININA CINETICA AA test system is a device to measure creatinine levels in human serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as calculation basis for measuring other urine analytes.
The "Wiener lab. Creatinina cincetca AA" creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are to measure croating to the atment of renal diseases, in monitoring renal dialysis, assulin the diagnools anis for measuring other urine analytes.
Product codes
JFY
Device Description
The Creatinine assay is a clinical chemistry assay in which the creatinine in the sample, at an alkaline pH, reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the amount of creatinine in the sample
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:
- RANDOX Test System: 10 mg/dl
- WIENER LAB. Test System: 20 mg/dl
- DMA Test System: 20 mg/dl
- WIENER LAB. Test System: 20 mg/dl
-
Minimum Detection Limit:
- RANDOX Test System: Not specified
- WIENER LAB. Test System: 0.012 mg/dl
- DMA Test System: 0.06 mg/dl
- WIENER LAB. Test System: 0.012 mg/dl
-
Expected Values:
- RANDOX Test System (Serum): Male: 0.6-1.1 mg/dl, Female: 0.5-0.9 mg/dl
- WIENER LAB. Test System (Serum): 0.8-1.4 mg/dl; (Urine): 0.8-2.0 g/24hs; E.C.C.: 71-135 ml/min until 60 years
- DMA Test System (Serum): 0.4-1.6 mg/dl; (Urine): 0.6-1.6 g/24hs; E.C.C.: Males: 85-125 ml/min, Females: 75-115 ml/min
- WIENER LAB. Test System (Serum): 0.8-1.4 mg/dl; (Urine): 0.8-2.0 g/24hs; E.C.C.: 71-135 ml/min until 60 years
-
Within-run Precision:
- RANDOX Test System: No stated in insert.
- WIENER LAB. Test System: Normal Serum Control: CV = 1.0%, Abnormal Serum Control: CV = 0.6%, Low Level Urine CV = 0.4%, High Level Urine CV = 0.5%
- DMA Test System: Normal Serum Control: CV = 2.9%, Abnormal Serum Control: CV = 1.3%
- WIENER LAB. Test System: Normal Serum Control: CV = 1.0%, Abnormal Serum Control: CV = 0.6%, Low Level Urine CV = 0.4%, High Level Urine CV = 0.5%
-
Total Precision:
- RANDOX Test System: No stated in insert.
- WIENER LAB. Test System: Normal Serum Control: CV = 1.7%, Abnormal Serum Control: CV = 1.0%, Low Level Urine CV = 0.7%, High Level Urine CV = 1.1%
- DMA Test System: Normal Serum Control: CV = 4.2%, Abnormal Serum Control: CV = 1.7%
- WIENER LAB. Test System: Normal Serum Control: CV = 1.7%, Abnormal Serum Control:
Predicate Device(s)
RANDOX CREATININE (Cat. Nº CR510), DMA CREATININE (Cat. Nº 1430)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
0
OCT 1 0 2001
Image /page/0/Picture/2 description: The image is a black and white circular seal or logo. The text "Wiener lab." is arranged along the top curve of the circle. Inside the circle, the text "ISO 9001" is prominently displayed above a logo that includes the text "TUV CERT". The phrase "SISTEMA DE CALIDAD CERTIFICADO" is arranged along the bottom curve of the circle.
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 Clinicos" 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: ূপ্যাব্যক্ত ני נ
Introduction
According to the requirements of 21 CFR 862.1580, the following information provides sufficient details to understand the basis of a determination of substantial equivalence.
Wiener Laboratorios S.A.I.C. 6-1 Submitter Name, Address, Riobamba 2944 2000 - Rosario - Argentina Contact Tel: 54 341 4329191 Fax: 54 341 4851986 Contact person: Viviana Cétola Date Prepared: March 19, 2001
1
Common name: Creatinine test system Classification name: Alkaline picrate, colorimetry, creatinine, CGX, as per 21 CFR section 862.1225. Device Class II We claim substantial equivalence to the currently marketed 6-3 Predicate Device "RANDOX CREATININE" Test system (Cat. Nº CR510) for the serum / plasma application and "DMA CREATININE" Test system (Cat. Nº 1430) for the urine application. 6-4 Device The Creatinine assay is a clinical chemistry assay in which the Description creatinine in the sample, at an alkaline pH, reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the amount of creatinine in the sample 6-5 Intended Use The CREATININA CINETICA AA test system is a device to measure creatinine levels in human serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as calculation basis for measuring other urine analytes. The CREATININA CINETICA AA test system is substantially 6-6 Equivalencies and Differences equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed RANDOX CREATININE test system for the serum / plasma application and DMA CREATININE test system for the urine application. The following table illustrates the similarities and differences between the WIENER LAB CREATININA CINETICA AA test system and the currently marketed RANDOX CREATININE test system.
Proprietary name: Wiener lab. CREATININA CINETICA AA
6-2 Device Name
2
| | RANDOX Test
System | WIENER LAB.
Test System |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative
determination of
creatinine in human
serum and plasma. | Quantitative
determination of
creatinine in human
serum, plasma and
urine. |
| Test Principle | The Creatinine assay is a clinical chemistry
assay in which the creatinine in the sample,
at an alkaline pH, reacts with picrate to
form a creatinine-picrate complex. The rate
of increase in absorbance at 500 nm due to
the formation of this complex is directly
proportional to the amount of creatinine in
the sample. | |
| Essential
Components | Picric acid and NaOH | |
| Reagents | R1: Picric acid /
Surfactant
R2: NaOH | R1: Picric acid
R2: Carbonate /
NaOH |
| Preparation of
Working Reagent | Mixture of R1 and R2
(1:1) | Mixture of R1 and
R2 (1:1) or they can
be used separately. |
| Working Reagent
Stability | Stable 3 days at 15-
25°C in closed plastic
bottle | Stable 7 days at
room temperature in
closed plastic bottle
and 24 hours on
autoanalvzer |
| Sample | Human serum and
plasma. | Human serum,
plasma and urine. |
| Working
Temperatures | 25 - 30 - 37°C | |
| Wavelength of
reading. | 490-510 nm | |
| Calibrator and Serum
Controls | Available - provided separately | |
| Continued on next page | | |
| | RANDOX Test
System | WIENER LAB.
Test System |
| Linearity | 10 mg/dl | 20 mg/dl |
| Minimum Detection
Limit | Not specified | 0.012 mg/dl |
| Expected Values | Serum (mg/dl)
Male: 0.6-1.1
Female: 0.5-0.9 | Serum
0.8-1.4 mg/dl
Urine
0.8-2.0 g/24hs
E.C.C.
71-135 ml/min
until 60 years |
| Within-run Precision | No stated in insert. | Normal Serum
Control:
CV = 1.0%
Abnormal Serum
Control:
CV = 0.6%
Low Level Urine
CV = 0.4%
High Level Urine
CV = 0.5% |
| Total Precision | No stated in insert. | Normal Serum
Control:
CV = 1.7%
Abnormal Serum
Control:
CV = 1.0%
Low Level Urine
CV = 0.7%
High Level Urine
CV = 1.1% |
3
creatinina cinetica aa v
The following table illustrates the similarities and differences The following table finastration the CININA CONETICA AA test between the vriently marketed DMA CREATININE test system.
4
CREATININA CINETICA AA Wiener lab.
| | DMA Test System | WIENER LAB.
Test System |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative
determination of
creatinine in human
serum and urine. | Quantitative
determination of
creatinine in human
serum, plasma and
urine. |
| Test Principle | The Creatinine assay is a clinical chemistry
assay in which the creatinine in the sample,
at an alkaline pH, reacts with picrate to
form a creatinine-picrate complex. The rate
of increase in absorbance at 500 nm due to
the formation of this complex is directly
proportional to the amount of creatinine in
the sample | |
| Essential
Components | Picric acid and NaOH | |
| Reagents | R2: Picric acid
R1: NaOH, sodium
borate and
surfactant | R1: Picric acid
R2: Carbonate /
NaOH |
| Preparation of
Working Reagent | Mixture of R1 and
R2 (1:1) | Mixture of R1 and R2
(1:1) or they can be
used separately. |
| Working Reagent
Stability | Stable 14 days at
15-30°C in closed
plastic bottle | Stable 7 days at room
temperature in closed
plastic bottle and 24
hours on
autoanalyzer |
| Sample | Human serum and
urine | Human serum,
plasma and urine |
| Working
Temperatures | 30 - 37°C | 25 - 30 - 37°C |
| Wavelength of
reading. | 490-510 nm | |
| Calibrator and Serum
Controls | Available - provided separately | |
| Linearity | 20 mg/dl | 20 mg/dl |
| Continued on next page | | |
| | DMA Test
System | WIENER LAB.
Test System |
| Minimum Detection
Limit | 0.06 mg/dl | 0.012 mg/dl |
| Expected Values | Serum
0.4-1.6 mg/dl
Urine
0.6-1.6 g/24hs
E.C.C.
Males: 85-125
ml/min
Females: 75-115
ml/min | Serum
0.8-1.4 mg/dl
Urine
0.8-2.0 g/24hs
E.C.C.
71-135 ml/min
until 60 years |
| Within-run Precision | Normal Serum
Control:
CV = 2.9%
Abnormal Serum
Control:
CV = 1.3% | Normal Serum
Control:
CV = 1.0%
Abnormal Serum
Control:
CV = 0.6%
Low Level Urine
CV = 0.4%
High Level Urine
CV = 0.5% |
| Total Precision | Normal Serum
Control:
CV = 4.2%
Abnormal Serum
Control:
CV = 1.7% | Normal Serum
Control:
CV = 1.7%
Abnormal Serum
|
5
Ko12065
6-7 Conclusion
Above mentioned data show substantial equivalency to the predicate devices.
6
Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 0 2001
Dr. Viviana Cetola QC/QA Manager Wiener Laboratorios S. A. I. C. Riobamba 2944 Rosario, Santa Fe Argentina
Re: K012065 Trade/Device Name: Creatinina Cinetica AA Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY Dated: August 30, 2001 Received: September 10, 2001
Dear Dr. Cetola:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be 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 conninered pror to Tria) 2011-03-11 (1) accordance with the provisions of the Federal Food, Drug, de necs that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dierelere, mains 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 If your de rise to such additional controls. Existing major regulations affecting your device can may or babyer to deem waters as Regulations, Title 21, Parts 800 to 898. 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 r lease be determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I odolar statutes and states and station of limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 6077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
Page 2 -
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 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/cdrb/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
8
CDRH ODE
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Wiener
Creatining
Indications For Use:
The "Wiener lab. Creatinina cinética AA" creatinine test system is a device intended The Wiener creatinine levels in plasma and urine. Creatinine measurements are to measure croating to the atment of renal diseases, in monitoring renal dialysis, assulin the diagnools anis for measuring other urine analytes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Alexander Charaper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012065
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
SK24