(100 days)
The "Wiener lab. Creatinina cinética AA" creatinine test system is a device intended 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 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
Here's a breakdown of the acceptance criteria and study information for the "Wiener lab. CREATININA CINETICA AA" test system, based on the provided text:
Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not necessarily on presenting a full study report with detailed acceptance criteria and performance data for every characteristic. Therefore, some information, particularly regarding specific acceptance criteria thresholds for each performance metric, may not be explicitly stated as "acceptance criteria" but can be inferred from the comparison to the predicate devices. The study is a comparative effectiveness study against predicate devices. No information is available for training set.
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
For the "Wiener lab. CREATININA CINETICA AA" test system, acceptance criteria are implicitly tied to demonstrating performance that is equivalent to or better than the predicate devices ("RANDOX CREATININE" and "DMA CREATININE").
| Performance Metric | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Wiener Lab.) |
|---|---|---|
| Intended Use | Quantitative determination of creatinine in human serum and plasma (RANDOX); Quantitative determination of creatinine in human serum and urine (DMA). | Quantitative determination of creatinine in human serum, plasma and urine. (Broader than RANDOX, matched with DMA) |
| 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. | 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. (Identical) |
| Essential Components | Picric acid and NaOH (RANDOX & DMA) | Picric acid and NaOH (Identical) |
| Reagents | RANDOX: R1: Picric acid/Surfactant, R2: NaOH; DMA: R2: Picric acid, R1: NaOH, sodium borate and surfactant. | R1: Picric acid, R2: Carbonate / NaOH. (Similar but with Carbonate in R2 for Wiener Lab.) |
| Preparation of Working Reagent | Mixture of R1 and R2 (1:1) (RANDOX & DMA) | Mixture of R1 and R2 (1:1) or they can be used separately. (More flexible) |
| Working Reagent Stability | RANDOX: Stable 3 days at 15-25°C in closed plastic bottle; DMA: 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. (Better than RANDOX, different from DMA with both longer room temp and autoanalyser stability) |
| Sample | Human serum and plasma (RANDOX); Human serum and urine (DMA). | Human serum, plasma and urine. (Broader than RANDOX, identical to DMA) |
| Working Temperatures | RANDOX: 25 - 30 - 37°C; DMA: 30 - 37°C. | 25 - 30 - 37°C (Matches RANDOX, broader than DMA) |
| Wavelength of Reading | 490-510 nm (RANDOX & DMA) | 490-510 nm (Identical) |
| Calibrator & Serum Controls | Available - provided separately (RANDOX & DMA) | Available - provided separately (Identical) |
| Linearity | RANDOX: 10 mg/dl; DMA: 20 mg/dl. | 20 mg/dl (Better than RANDOX, identical to DMA). |
| Minimum Detection Limit | RANDOX: Not specified; DMA: 0.06 mg/dl. | 0.012 mg/dl (Significantly better than DMA, and specified unlike RANDOX). |
| Expected Values (Serum) | RANDOX: Male: 0.6-1.1 mg/dl, Female: 0.5-0.9 mg/dl; DMA: 0.4-1.6 mg/dl. | 0.8-1.4 mg/dl. (Comparable ranges, within typical variations for healthy populations) |
| Expected Values (Urine) | RANDOX: N/A; DMA: 0.6-1.6 g/24hs. | 0.8-2.0 g/24hs. (Comparable range, slightly larger upper end) |
| Within-run Precision | RANDOX: No stated in insert; DMA: 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%. (Significantly better CV than DMA; specified when RANDOX was not). |
| Total Precision | RANDOX: No stated in insert; DMA: Normal Serum Control: CV = 4.2%, Abnormal Serum Control: CV = 1.7%. | Normal Serum Control: CV = 1.7%; Abnormal Serum Control: CV = 1.0%; Low Level Urine: CV = 0.7%; High Level Urine: CV = 1.1%. (Significantly better CV than DMA; specified when RANDOX was not). |
Summary of Device Performance vs. Predicates:
The Wiener lab. Creatinina Cinetica AA test system generally meets or exceeds the performance characteristics of its predicate devices, especially in areas like linearity, minimum detection limit, and precision (which are more quantitative metrics with direct comparison available). The "Conclusion" section explicitly states that the "Above mentioned data show substantial equivalency to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated. The document presents comparative performance data (e.g., precision, linearity, detection limits, expected values) but does not detail the number of individual patient samples or control runs used to generate this data. It only lists performance metrics.
- Data Provenance: Not explicitly stated. The submitter is Wiener Laboratorios S.A.I.C. based in Rosario, Argentina. It is not specified whether the data for the performance characteristics was generated in Argentina or elsewhere, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts & Qualifications: Not applicable. This device is a clinical chemistry assay, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for such assays typically comes from established reference methods, spiked samples, or certified control materials with known concentrations. The document does not describe the methodology for establishing ground truth for the performance studies, other than implying the use of controls and calibrators.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As a quantitative clinical chemistry assay, adjudication by multiple human readers is not relevant. Performance is measured against analytical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This document concerns a chemical assay, not an interpretive diagnostic.
- Effect Size: Not applicable.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study: Yes, in essence, the reported performance characteristics (linearity, detection limit, precision, etc.) represent the standalone performance of the assay system itself. There is no "human-in-the-loop" component in the direct operation or result generation of a creatinine assay; the system provides a direct quantitative measurement.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for evaluating the performance metrics of a quantitative chemical assay like creatinine typically involves:
- Reference Standards/Calibrators: Solutions with precisely known concentrations of creatinine.
- Quality Control Materials: Commercial controls with established target ranges (e.g., normal serum control, abnormal serum control, urine controls).
- Spiked Samples: Patient samples to which a known amount of analyte has been added to test recovery and linearity.
- Comparison to Reference Methods: While not explicitly detailed as the "ground truth" for all metrics, the comparison to predicate devices implies that the performance is benchmarked against established, legally marketed systems.
The document does not detail the specific ground truth methods for each reported metric, but these are the standard approaches for such devices.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not provided. This is a chemical assay, not a machine learning or AI-driven algorithm that requires a "training set" in the typical sense. Its performance is based on the chemical reactions and spectrophotometric measurements. The formulation of reagents and optimization of the method would be part of product development, but not an AI-style "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, there is no "training set" in the AI/machine learning context for this device.
{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: 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: ূ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 TestSystem | WIENER LAB.Test System | |
|---|---|---|
| Intended Use | Quantitativedetermination ofcreatinine in humanserum and plasma. | Quantitativedetermination ofcreatinine in humanserum, plasma andurine. |
| Test Principle | The Creatinine assay is a clinical chemistryassay in which the creatinine in the sample,at an alkaline pH, reacts with picrate toform a creatinine-picrate complex. The rateof increase in absorbance at 500 nm due tothe formation of this complex is directlyproportional to the amount of creatinine inthe sample. | |
| EssentialComponents | Picric acid and NaOH | |
| Reagents | R1: Picric acid /SurfactantR2: NaOH | R1: Picric acidR2: Carbonate /NaOH |
| Preparation ofWorking Reagent | Mixture of R1 and R2(1:1) | Mixture of R1 andR2 (1:1) or they canbe used separately. |
| Working ReagentStability | Stable 3 days at 15-25°C in closed plasticbottle | Stable 7 days atroom temperature inclosed plastic bottleand 24 hours onautoanalvzer |
| Sample | Human serum andplasma. | Human serum,plasma and urine. |
| WorkingTemperatures | 25 - 30 - 37°C | |
| Wavelength ofreading. | 490-510 nm | |
| Calibrator and SerumControls | Available - provided separately | |
| Continued on next page | ||
| RANDOX TestSystem | WIENER LAB.Test System | |
| Linearity | 10 mg/dl | 20 mg/dl |
| Minimum DetectionLimit | Not specified | 0.012 mg/dl |
| Expected Values | Serum (mg/dl)Male: 0.6-1.1Female: 0.5-0.9 | Serum0.8-1.4 mg/dlUrine0.8-2.0 g/24hsE.C.C.71-135 ml/minuntil 60 years |
| Within-run Precision | No stated in insert. | Normal SerumControl:CV = 1.0%Abnormal SerumControl:CV = 0.6%Low Level UrineCV = 0.4%High Level UrineCV = 0.5% |
| Total Precision | No stated in insert. | Normal SerumControl:CV = 1.7%Abnormal SerumControl:CV = 1.0%Low Level UrineCV = 0.7%High Level UrineCV = 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 | Quantitativedetermination ofcreatinine in humanserum and urine. | Quantitativedetermination ofcreatinine in humanserum, plasma andurine. |
| Test Principle | The Creatinine assay is a clinical chemistryassay in which the creatinine in the sample,at an alkaline pH, reacts with picrate toform a creatinine-picrate complex. The rateof increase in absorbance at 500 nm due tothe formation of this complex is directlyproportional to the amount of creatinine inthe sample | |
| EssentialComponents | Picric acid and NaOH | |
| Reagents | R2: Picric acidR1: NaOH, sodiumborate andsurfactant | R1: Picric acidR2: Carbonate /NaOH |
| Preparation ofWorking Reagent | Mixture of R1 andR2 (1:1) | Mixture of R1 and R2(1:1) or they can beused separately. |
| Working ReagentStability | Stable 14 days at15-30°C in closedplastic bottle | Stable 7 days at roomtemperature in closedplastic bottle and 24hours onautoanalyzer |
| Sample | Human serum andurine | Human serum,plasma and urine |
| WorkingTemperatures | 30 - 37°C | 25 - 30 - 37°C |
| Wavelength ofreading. | 490-510 nm | |
| Calibrator and SerumControls | Available - provided separately | |
| Linearity | 20 mg/dl | 20 mg/dl |
| Continued on next page | ||
| DMA TestSystem | WIENER LAB.Test System | |
| Minimum DetectionLimit | 0.06 mg/dl | 0.012 mg/dl |
| Expected Values | Serum0.4-1.6 mg/dlUrine0.6-1.6 g/24hsE.C.C.Males: 85-125ml/minFemales: 75-115ml/min | Serum0.8-1.4 mg/dlUrine0.8-2.0 g/24hsE.C.C.71-135 ml/minuntil 60 years |
| Within-run Precision | Normal SerumControl:CV = 2.9%Abnormal SerumControl:CV = 1.3% | Normal SerumControl:CV = 1.0%Abnormal SerumControl:CV = 0.6%Low Level UrineCV = 0.4%High Level UrineCV = 0.5% |
| Total Precision | Normal SerumControl:CV = 4.2%Abnormal SerumControl:CV = 1.7% | Normal SerumControl: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
§ 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.