ELAN ALKALINE PHOSPHATE REAGENT KIT

{0}------------------------------------------------ K991387 34 MAY 1 9 1000 élan diagnostics Image /page/0/Picture/3 description: The image shows a logo for "élan". The logo consists of a stylized letter "e" formed by multiple parallel lines curving around to create a circular shape. To the left of the "e", there are three horizontal lines extending outward, suggesting movement or direction. Below the symbol, the word "élan" is written in a lowercase sans-serif font. SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 21 CFR 807.92. Elan ALP Reagent is intended for the quantitative determination of alkaline phosphatasc in serum and plasma nd plant of the same of any the wide with and interlinal diverder Flan ALP Reagent is intended for the qualificantes news.id, and intestinal disorders. The Elan ALP Reagent determines alkaline phosphatase by catalyzing the hydrolysis of p-nitrohenythosphate to The Elan ALP Reagent determines alkaline phosphalase of catalyzhig in 1970 - 1991 - 1991 p-nitrophenol. The resulting increase in absorbance at approximately 410 nm is propo phosphatase activity in the sample. The Elan AIJP Reagent is an adaptation of the AACC and IFCC methods, and is intended for use with the Beckman The Elan ALP Reagent is an adaptation of the AACC and ICC negired manipulations To support this Synchron CX-5 Autoanalyzer, or with analyzers willen ear attemate at other of those instruments. Iatter use, procedure supplication sheets) will be supplied to the users of t The Elan ALP Reagent is substantially equivalent to the Beckman® SYNCHRON® Systems ALP Reagent, production The Elan ALP Reagent is substantially equivalent to the Deckner of teenters of based on the same methodology no. 442670, manufactured by Beckman Instruments, Brea, CA. Doth c no. 442670, manufactured by the hydrolysis of p-nitrophenylphosphate to p-nitrophenol. The effectiveness of the Elan reagent application for the Beckman" Systems is shown by the The effectiveness of the Elan reagent application of crecovery of ferum controls for on-board recovery of linearity standards, the precision of control recovery of ferum cont recovery of linearity standards, the precision of control recovery of the records of patient speciments stability claims, the Vandation of chemical was and of Reagent. The recoveries of alkaline phosphatase using the Elan ALP Reagon on the SYNCHRON CXX ° Systems are linearity range. Regression The recoveries of alkaline phosphatase using ne read which span the linearity range. Regression from 5 U/L to 1000 U/L as shown by the recovery of linearity stant tartars wh from 5 U/L to 1000 U/L as shown by the recovery of mich is now and standard factors which range from 0 to 1251 U/L, are shown below. (Elan Recoveries) = 2.788 U/L + 0.990 x (Standard Factors), r2 = 1.000 Sys = 1.148, df = 10 Precision, demonstrated by replicate assays of commercially available control sera and a spiked high control is shown below. | Specimen | n | mean | within-run SD | total SD | |----------|----|-----------|---------------|----------| | low | 60 | 37.5 U/L | 1.34 | 1.36 | | medium | 60 | 251.4 U/L | 1.38 | 3.70 | | high | 60 | 740.6 U/L | 4.13 | 15.38 | 510(k) Notification, Elan Alkaline Phosphatase Reagent Kit Elan Diagnostics, Brea, California {1}------------------------------------------------ élan diagnostics Image /page/1/Picture/1 description: The image shows a logo for "élan". The logo features a stylized letter "e" formed by multiple curved lines, with three horizontal lines extending from the left side of the "e". Below the symbol is the word "élan" in a sans-serif font, with an acute accent over the "e". The logo is black and white. Alkaline phosphatase recoveries of 80 serum specimens and 78 plasma specimens are compared between the Elan and Beckman® AP Reagents on the SYNCHRON CX® Systems. Least squared regression statistics are shown below. Patients Comparisons: (Elan Results) = - 0.451 U/L + 0.9986 x (Beckman® Results) r2 = 0.9964 = S(x) = 3.059 n = 158 The use of anticoagulants, heparin and lithium iodoacetate are shown to be acceptable chemical additives by comparison of spiked and unspiked serum pools. In all cases, the addition of anticonnulants is less than 1.5 U/I . alkaline phosphatase and statistically insignificant. The detection limit claim of 5 U/L is documented through the repetitive assay of an alkaline phosphatase standard. The observed detection limit, calculated as three standard deviations of a 30 replicate within ruroprieision study is 1.845 U/I. and is below the claimed limit. The 10 day on-board reagent stability claim is documented through the assay of serum controls over the claimed periods. In all cases, the changes in alkaline phosphatasc recoveries over the test periods are less than 3 VL 6 6 % Ralph Belotti ⁵¹⁰⁽k) Notification, Flan Alkaline Phosphatase Reagent Kit Elan Diagnostics, Brea, California {2}------------------------------------------------ Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle. ## DEPARTMENT OF HEALTH & HUMAN SERVICES MAY 1 9 1990 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Ralph Bolstad Senior R & D Chemist Elan Diagnostics 231 North Puente Street Brea, California 92821 Rc: K991387 > Trade Name: Elan Alkalinc Phosphate Reagent Kit Regulatory Class: II Product Code: CJE Dated: April 19, 1999 Reccived: April 21, 1999 Dear Mr. Bolstad: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 misbranding and adultcration. If your device is classified (sec above) into cither class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic Q1 inspections, the Food and Drug Administration (FDA) will verify such assumptions. Tailure (o comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ ## Page 2 Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may 1988 (Clinical Laborators areassizetion - To determine if it does, you should c Under the Clinical Laboratory Improvement Amendiments of 1 706 (OEIF 2017) require a CLIA complexity categorization. To determine if it does, you should contact the first require a CLIA complexity categorization: 16 accential Centers for Disease Control and Prevention (CDC) at (770) 488-7655. Chiels in Lisease obla This letter will allow you to begin marketing your device to a legally harketed on Algally marketed notification. The FDA finding of substantial equivalence of your device t notification. The FDA finding of substantial equivalence of your device and thus, permits your device to proceed to the market. proceded on the for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your device on our labeling regulation (2) Office of Compliance at additionally 809.10 for in vitro diagnostic devices), please contact the If you desire open in vite dagnostic devices), please contact me of your device, (301) 594-4588. Al or in xitte diagnostic devices), please not the regulation (301) 594-4588. Additionally, for questions on the promotion and at were and (101) 594-4368. Premience at (301) 594-4639. Also, please note more in estable in estable in elemental entitled, "Misbranding by reference to premarket mor be obtained fro pressed on the mail on reference to premarket motification (1) CLFK of From the Division of Small entitled, "Misbranding by reference to premarked from the Division of Small entitude, Tresponsibilities under the Act may be oblamber (801) 443-6597, or at its Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at Manufacturers Assistance at its ton-free hands in ("." ") internet address "http://www.fda.gov/cdrlv/dsmaldsmamain.html". Sincerely yours, Steven Putman 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}------------------------------------------------ 510(k) Number (if known): Page 1 of 1 Device Name: Elan ALP Reagent Kit Indications For Use: Elan ALP Reagent is intended for the quantitative determination of alkalinc phosphatasc in serum and plasma for the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This reagent is intended to be used on a Beckman® SYNCHRON CX ® autoanalyzer in a professional setting or by trained personnel, and is not intended for home use. Respectively, Ralph Bolstad Senior R&D Chemist Elan Diagnostics 19 April, 1999 (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K991387 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) ✓ OR Over-The-Counter Use (Optional Format 1-2-96)