Who is the manufacturer of WIENER LAB. CREATININA CINETICA AA?

Wiener Laboratories Saic filed the 510(k) submission for WIENER LAB. CREATININA CINETICA AA (K012065).

What is the FDA product code for WIENER LAB. CREATININA CINETICA AA?

JFY. It is classified under 21 CFR 862.1225 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for WIENER LAB. CREATININA CINETICA AA?

510(k) clearance (submission type: Traditional).

What are the predicate devices for WIENER LAB. CREATININA CINETICA AA?

RANDOX CREATININE Test system (Cat. Nº CR510); DMA CREATININE Test system (Cat. Nº 1430).

Who can help prepare an FDA 510(k) submission like WIENER LAB. CREATININA CINETICA AA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

WIENER LAB. CREATININA CINETICA AA

K012065 · Wiener Laboratories Saic · JFY · Oct 10, 2001 · Clinical Chemistry

Device Facts

Record ID	K012065
Device Name	WIENER LAB. CREATININA CINETICA AA
Applicant	Wiener Laboratories Saic
Product Code	JFY · Clinical Chemistry
Decision Date	Oct 10, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1225
Device Class	Class 2

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.

Device Story

The Creatinina Cinetica AA is a clinical chemistry assay for measuring creatinine in human serum, plasma, and urine. The device utilizes an alkaline picrate colorimetric method; creatinine in the sample reacts with picrate at an alkaline pH to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm is measured, which is directly proportional to the creatinine concentration in the sample. The assay is intended for use in clinical laboratory settings by trained personnel. Results are used by clinicians to assess renal function, diagnose kidney disease, and monitor dialysis patients. The device provides quantitative data that informs clinical decision-making regarding patient renal health.

Clinical Evidence

Bench testing only. Performance data includes linearity (up to 20 mg/dl), minimum detection limit (0.012 mg/dl), and precision studies. Within-run precision (CV) reported as 0.4%–1.0% and total precision (CV) as 0.7%–1.7% across various serum and urine controls. No clinical prospective or retrospective studies were required for this submission.

Technological Characteristics

Clinical chemistry assay using alkaline picrate colorimetry. Reagents: R1 (Picric acid) and R2 (Carbonate/NaOH). Measurement wavelength: 500 nm. Working reagent stability: 7 days at room temperature or 24 hours on autoanalyzer. Compatible with standard clinical chemistry autoanalyzers.

Indications for Use

Indicated for the quantitative determination of creatinine in human serum, plasma, and urine to aid in the diagnosis and treatment of renal diseases, monitoring of renal dialysis, and as a calculation basis for other urine analytes.

Regulatory Classification

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.

Predicate Devices

RANDOX CREATININE Test system (Cat. Nº CR510)
DMA CREATININE Test system (Cat. Nº 1430)

Related Devices

K981799 — CREA · Abbott Laboratories · Jul 22, 1998
K210452 — Creatinine2 · Abbott Ireland Diagnostics Division · Mar 22, 2022
K083809 — CREATININE · Abbott Laboratories · Apr 7, 2009
K972743 — SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT · Sigma Diagnostics, Inc. · Sep 22, 1997

Submission Summary (Full Text)

{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}------------------------------------------------ K012062 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. K012065 | | 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 K012065 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