WIENER LAB. ALP 405

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a circular logo or seal, likely representing a certification or quality standard. The text "Wiener lab." is arranged along the top curve of the circle, while "SISTEMA DE CALIDAD CERTIFICADO" is along the bottom curve. In the center of the circle, there is a symbol resembling a stylized "W" above the text "ISO 9001" and the "TÜV CERT" logo. JAN 2 8 2002 Image /page/0/Picture/3 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, there 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: _ K013983 99 According to the requirements of 21 CFR 862.1050, the Introduction following information provides sufficient details to understand the basis of a determination of substantial equivalence. 6-1 Submitter Wiener Laboratorios S.A.I.C. Name, Address, Riobamba 2944 Contact 2000 - Rosario - Argentina > Contact person: Viviana Cétola Date Prepared: February 23, 2001 | 6-2 Device Name | Proprietary name: | WIENER LAB. ALP 405 | |-----------------|----------------------|-------------------------------------------------------------| | | Common name: | Alkaline phosphatase test system. | | | Classification name: | Nitrophenylphosphate, Alkaline<br>Phosphatase or Isoenzymes | | | Device Class II | | {1}------------------------------------------------ We claim substantial equivalence to the currently marketed 6-3 Predicate RANDOX ALKALINE PHOSPHATASE OPT. test system (Cat. Device Nº AP307). Alkaline phosphatase (ALP or orthophosphoric monoester 6-4 Device phosphohydrolase - EC 3.1.3.1.) hvdrolyzes colorless Description paranitrophenyl phosphate (pNPP) producing phosphate and p-nitrophenol at pH 9.8. The speed at which the p-nitrophenolate anion (yellow) appears, read at 405 nm, is directly proportional to the enzymatic activity of the sample. 6-5 Intended Use The ALP 405 test system is intended to be used in the quantitative determination of alkaline phosphatase in human serum and heparinized plasmas. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. 6-6 Equivalencies The WIENER LAB. ALP 405 test system is substantially equivalent to other products in commercial distribution and Differences intended for similar use. Most notably it is substantially equivalent to the currently marketed RANDOX ALKALINE PHOSPHATASE OPT test system. > The following table illustrates the similarities and differences between the WIENER LAB. ALP 405 test system and the currently marketed RANDOX ALKALINE PHOSPHATASE OPT test system. {2}------------------------------------------------ : | | RANDOX<br>Test System | WIENER LAB. Test<br>System | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Intended use | Quantitative determination of alkaline phosphatase<br>in human serum and heparinized plasma. | | | Test principle | Alkaline phosphatase (ALP or orthophosphoric<br>monoester phosphohydrolase - EC 3.1.3.1.)<br>hydrolyzes colorless paranitrophenyl phosphate<br>(pNPP) producing phosphate and p-nitrophenol at<br>pH 9.8. The speed at which the p-nitrophenolate<br>anion (yellow) appears, read at 405 nm, is directly<br>proportional to the enzymatic activity of the sample. | | | Essential<br>Components | p-Nitrophenylphosphate (p-NPP) - DEA | | | Reagents | R1: p-NPP<br>R2: Buffer | R1: p-NPP<br>R2: Buffer | | Instability or<br>deterioration of<br>reagents | Not specified | Reagent Blank<br>Absorbance > 0.900 | | Sample | Human serum and heparinized plasma | | | Working<br>Temperatures | 25 - 30 - 37°C | | | Wavelength of<br>reading. | 405 nm | | | Linearity | 825 U/I | 1,400 U/I | | Minimum<br>detection limit | Not specified | 8.7 U/I | | | | Continued on next page | | | RANDOX<br>Test System | WIENER LAB. Test<br>System | | Expected values | Adults:<br>98 - 279 U/l (37°C) | Adults:<br>65 - 300 U/l (37°C)<br>Children:<br>until 645 (37°C) | | Within-run<br>precision | No stated in insert. | Normal Serum Control:<br>CV = 2.2%<br>Abnormal Serum Control:<br>CV = 0.7% | | Total precision | No stated in insert. | Normal Serum Control:<br>CV = 2.4%<br>Abnormal Serum Control:<br>CV = 0.9% | : لقيق المقتلبة المقتلبة المقتلبة المقتلبة المقتلبة المقاومة المنتخب المنتخب المنتخب المنتخب المنتخب المنتجات المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب ا 6 - 3 {3}------------------------------------------------ 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 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three wavy lines that resemble a bird in flight. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JAN 2 8 2002 Dr. Vivianna Cetola QC/QA Manager Weiner Laboratorios S.A.I.C. Riobamba 2944. Rosairo 2000 Santa Fe Argentina k013983 Re: > Trade/Device Name: Weiner Lab. ALP 405 Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CJE Dated: November 14, 2001 Received: December 3, 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 commerce 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. {5}------------------------------------------------ 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 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/odrb/dsma/dsmamain.html". Sincerely yours, Steven Dutman 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 {6}------------------------------------------------ CDRH ODE K0/3983 Page / of / | 510(k) Number (if known): | K013983 | |---------------------------|-------------| | Device Name: | Wiener lab. | | | ALP 405 | ## Indications For Use: The "Wiener lab. ALP 405" test system is an in vitro diagnostic device intended to be used in the quantitative determination of alkaline phosphatase in human serum and heparimized plasmas. Measurements of alkaline phosphatase or its isoenzymes are used Measurements of alkaline proophalas of liver, bone, parathyroid, and intestinal diseases. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDBOD Concurrence of CDRH, Office of Device Evaluation (ODE) Carol C Benson for Jean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices K013983 510(k) Number _ Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96) H C SKEE