WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA

{0}------------------------------------------------ DEC 21 2001 Image /page/0/Picture/1 description: The image is a circular logo or seal with the text "Wiener lab." at the top. Inside the circle, there is a symbol resembling an upside-down "W" above the text "ISO 9001". Below that, there is another logo with the text "TUV CERT". The text "SISTEMA DE CALIDAD CERTIFICADO" is written around the bottom half of the circle. Image /page/0/Picture/2 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" inside 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: كـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ 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. 1) Submitter Riobamba 2944 Name, 2000 - Rosario - Argentina Address, Tel: 54 341 4329191 Contact Fax: 54 341 4851986 Contact person: Viviana Cétola Date Prepared: June 04, 2001 Continued on next page {1}------------------------------------------------ #### GLICEMIA LAB. WIENER 2) Device name Proprietary name: ENZIMATICA AA Common name: Glucose test system. Classification name: Glucose oxidase, glucose as per 21CFR section 862.1345. Device Class II 3) Predicate Device We claim substantial equivalence to the currently (DMA) Data Medical Associates, Inc. marketed GLUCOSE (Oxidase) test system. 4) Device description End point method. The Wiener lab. Glicemia enzimatica AA is based on the following reaction system: $$\text{Glucose} + \text{O}_{2} + \text{H}_{2}\text{O} \xrightarrow{\text{GOD}} \text{Gluconic Acid} + \text{H}_{2}\text{O}_{2}$$ $$2 \text{ H}_{2}\text{O}_{2} + \text{4-AP} + \text{4-Hydroxybenzoate} \xrightarrow{\text{POD}} \text{red}$$ The amount of glucose is determined by measuring the absorbance of this pigment GOD (glucose oxidase) POD (peroxidase) 4-AP (4-aminophenazone). Continued on next page {2}------------------------------------------------ 5) Intended use The GLICEMIA ENZIMATICA AA test system is intended to be used in the quantitative determination of glucose in human serum and plasma on both manual and automated systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal including disorders hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. # 6) Equivalencies The WIENER LAB. GLICEMIA ENZIMATICA AA test system is substantially equivalent to other products in Equivalorioloo of oyensial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed DMA GLUCOSE (oxidase) test system. > The following table illustrates the similarities and differences between the WIENER LAB. GLICEMIA ENZIMATICA AA test system and the currently marketed DMA GLUCOSA test system. | | DMA<br>Test System | WIENER LAB.<br>Test System | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------| | Intended use | Quantitative determination of glucose in<br>human serum and plasma. | | | Test principle | End point method. | | | | The principle is based on the following<br>reaction system:<br>$Glucose+O2+H2O ⟶GOD Gluconic Acid +H2O2$ $2 H2O2+4-AP+4-Hydroxybenzoate ⟶POD red quinonimine$ | | | Essential<br>Components | GOD - POD -<br>Mutarotase - 4-AP<br>Hydroxybenzoate | GOD - POD - 4-AP<br>Hydroxybenzoate | Continued on next page {3}------------------------------------------------ : 11.000 | Calibrator and<br>Serum Controls | Available - provided separately | | |------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Instability or<br>deterioration of<br>reagents | Blank Absorbance<br>> 0.300. | Blank Absorbance<br>> 0.160. | | | Abnormal values of<br>controls. | Abnormally low<br>Standard<br>Absorbance. | | Sample | Human serum, heparinized plasmas,<br>potassium oxalate/fluoride and<br>EDTA/fluoride plasmas | | | Working<br>Temperature<br>Range | 37°C | Manual: 15 - 37°C<br>Automated: 37°C | | Stability of final<br>color | Not specified | 30 minutes | | Wavelength of<br>reading. | 505 nm | | | Calibration | Single point | | | Linearity | 1000 mg/dl | 500 mg/dl | | Minimum<br>detection limit | 1.4 mg/dl | 0.544 mg/dl | | Expected values | 75 - 113 mg/dl<br>(70 - 105 mg/dl) | 70 - 110 mg/dl<br>(70 - 105 mg/dl) | | Intra-assay<br>precision | Normal Serum<br>Control:<br>CV = 0.66% | Normal Serum<br>Control:<br>CV = 1.39% | | | Abnormal Serum<br>Control:<br>CV = 0.58% | Abnormal Serum<br>Control:<br>CV = 1.11% | | Inter-assay<br>precision | Normal Serum Control:<br>CV = 1.22%<br>Abnormal Serum Control:<br>CV = 0.91% | Normal Serum Control:<br>CV = 1.92%<br>Abnormal Serum Control:<br>CV = 1.62% | | | Sterility<br>conditions | Not required | Continued on next page ------ {4}------------------------------------------------ ## 7) Conclusion ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Above mentioned data show substantial equivalency to the predicate device. ・ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized, overlapping shapes that resemble a caduceus, a symbol often associated with healthcare. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 2 1 2001 Dr. Viviana Cétola QC/QA Manager Weiner Laboratorios S.A.I.C. 2944 Riobamba Rosario, Santa Fe, Argentina Re: k011953 Trade/Device Name: Glicemia enzimatica AA Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA Dated: October 1, 2001 Received: October 9, 2001 Dear Dr. Cetola: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 more prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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. {6}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and it you finding of substantial equivalence of your device to a legally marketed nouncation. THE FDF Intention 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 II you desire specific across ic devices), please contact the Office of Compliance at additionally 007.10 for millionally, for questions on the promotion and advertising of your device, (301) 594-4500. Traditional (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 mornation on your respondiations on 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 Sutman 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 {7}------------------------------------------------ CORR UNE | 510(k) Number (if known): | K011953 | |---------------------------|------------------------| | Device Name: | Wiener lab. | | | Glicemia enzimática AA | ## Indications For Use: The “Wiener lab. Glicemia enzimática AA” test system is intended to be The Wichel lub. Shoon a termination of glucose in human serum and both manual and automated Glucose systems. plasma on and treatment of the diagnosis measurements are used in diabetes carbohydrate metabolism disorders including mellitus, hypoglycemia, and of idiopathic neonatal hypoglycemia, and pancreatic islet cell carcinoma. Jean Cooper (Division Sign- Division of Clire Laboratory Devices 510(k) Numbe: Kol1953 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NERDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)