ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS

{0}------------------------------------------------ élan diagnostics Image /page/0/Picture/1 description: The image shows a logo for "élan". The logo features a stylized letter "e" formed by several curved lines, with a series of horizontal lines extending from the left side of the "e", resembling motion lines. Below the symbol is the word "élan" in a bold, sans-serif font, with an acute accent over the "e". K013/52 ## SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION NOV 0 9 2001 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The ATAC PAK Direct HDL Reagent Kit, the ATAC Direct HDL Calibrator and the ATAC 8000 Random Access THE ATAC PAR DIFOR INDE ROLE AS a system for the quantitative determination of HDL-cholesterol in serum and Chemisty System are intended for ass a a Frientis and treatment of lipid disorders (such as diabetes mellius), plasma. HDL-cholesteros results and renal diseases, and for the assessment of the risk of developing cardiovascular disease. The ATAC PAK Direct HDL Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase and The HIAC ITAN Dates 1122 Nother sources of cholesterol inactive. The resulting increase in absorbance at approximately 600 nm is proportional to the HDL-cholesterol concentration in the sample. The ATAC PAK Direct HDL Reagent Kit, calibrated with the ATAC Direct HDL Calibrator, is substantially equivalent to the Roche HDL-Cholesterol plus Reagent Kit, product no. 1930672, calibrated with Roche C.f.a.s HDL/LDL-C plus calibrator, product no. 1972235, which are currently marketed by Roche Inc. of Indianapolis, IN. The effectiveness of ATAC PAK Direct HDL Reagent Kit and the ATAC Direct HDL used on the ATAC 8000 Random Access Chemistry System is shown by the following studies. The recovery of HDL-cholesterol using the ATAC PAK Direct HDL Reagent is linear from 10 to 140 mg/dL as shown by the recovery of linearity standards that span the usable range. Linear regression statistics, with the regression line forced through the origin, compare standard recoveries to standard factors. (ATAC Recoveries) = 0 mg/dL + 0.9570 x (Standard Factors), sv.x = 4.5 mg/dL, n = 40 r = 0.995. Precision is demonstrated by the replicate assay of commercially available control serum and a serum pool. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below. | Sample | n | mean | Within Run | | Total | | |---------|----|------|------------|------|-------|------| | | | | 1SD | %CV | 1SD | %CV | | Serum 1 | 66 | 26 | 1.0 | 3.8% | 1.9 | 7.4% | | Serum 2 | 66 | 55 | 1.5 | 2.8% | 2.8 | 5.1% | | Serum 3 | 66 | 68 | 2.0 | 2.9% | 2.7 | 3.9% | Mixed serum and plasma specimens, collected from adult patients, were assayed for HDL-cholesterol using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compares regression and the following statistics were obtained. Serum/Plasma Comparison ATAC 8000 = 2.8 mg/dL + 0.912 x Competitive Reagent range = 4.7 - 123 mg/dL r = 0.978 n = 156 510(k) Notification, ATAC PAK Direct HDL Reagent Kit, 19 Sept., 2001, p 49 Elan Diagnostics 1075 W. Lambert Road · Brea California 92821 Phone: 714.672.3553 · Fax: 714.672.3554 {1}------------------------------------------------ The detection limit claim of 10 mg/dL is documented through the repetitive assay of a diluted serum pool. The observed detection limit, calculated as two standard deviations of a 30 replicate within run precision study, is 1.5 mg/dL and is below the claimed limit. The 30 day on board reagent stability and 14 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of HDL-cholesterol recoveries over the test periods are less than 3 mg/dL or 6%. Wynn Storking Wynn Storking Wynn Stocking Manager of Regulatory Affairs Elan Diagnostics 510(k) Notification, ATAC PAK Direct HDL Reagent Kit, 19 Sept., 2001, p 50 Elan Diagnostics 1075 W. Lambert Road · Brea California 92821 Phone: 714.672.3553 · Fax: 714.672.3554 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 2098 Gaither Road Rockville MD 20850 NOV 0 9 2001 Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road Brea, CA 92821 Re: k013152 Trade/Device Name: ATAC PAK Direct HDL Reagent; ATAC Direct HDL Calibrator Regulation Number: 21 CFR 862.1150; : 21 CFR 862.1475 Regulation Name: Calibrator; Lipoprotein test system Regulatory Class: Class II; Class I, reserved Product Code: JIS; LBS Dated: September 19, 2001 Received: September 20, 2001 Dear Mr. Stocking: 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. {3}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and wyou would of substantial equivalence of your device to a legally marketed nouticate 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 IT you desire specific an 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, (201) 59 react 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 mornation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or 1901) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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 {4}------------------------------------------------ ## NOV 0 9 2001 510(k) Number (if known): ATAC PAK Direct HDL Reagent and ATAC Direct HDL Calibrator Indications For Use: Device Name: The ATAC PAK Direct HDL Reagent Kit, the ATAC Direct HDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of HDL-cholesterol in serum and plasma. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the risk of developing cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use. KO13152 Respectfully, Wynn Stocking Wynn Stocking Regulatory Affairs Manager Elan Diagnostics 19 September, 2001 Rull chole for Jam coop (Divisi-Off) Divinonomnical Laboratory 510(k) Number K013152 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) **Prescription Use** (Per 21 CFR 801.109) X OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)