HICHEM CHOLESTEROL REAGENT KIT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for HiChem Diagnostics. The logo features a black circle at the top, followed by the words "HiChem" in large, bold letters. Below "HiChem" is the word "DIAGNOSTICS" in smaller letters. To the right of the black circle are the words "Smart Solutions" in a smaller, italicized font. K982469 ## SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION This summary of 510(k) safely and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFF 807 ee SMDA 1990 and 21 CFR 807.92. HiChem Cholesterol Reagent is intended for the quantitative determination of total cholesterol in serum and plasma. Measurements of total checked are used in the diagnosis and treatment of the choisecon in series cholesters in the blood and lipid and lipoprotein metabolism disorders. The HiChem Cholesterol Reagent determines cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase. The resulting increase in absorbance at one of interested estable concessed on concentration in the sample. The HiChem Cholesterol Reagent is an adaptation of the method first described by Allain and is intended for use with manual spectrophotometers or clinical analyzers which can automate the required manipulations. The HiChem Cholesterol Reagent is substantially equivalent to the Beckman® SYNCHRON® Systems Cholesterol Reagent, product no. 467825, manufactured by Beckman® Instruments, Brea, CA. All three reagents support the same intended use and produce equivalent results with the same clinical products support ne same mended on the same methodology which determines total cholesterol through the enzymatic action of the are and cholesterol oxidase. The effectiveness of the manual procedure is shown by the recovery of linearity standards, the precision of control recoveries, the comparison of serum and plasma recoveries to the Beckman® Cholesterol Reagent and the validation of the chemical additives and sensitivity claims. The recovery of total cholesterol using HiChem Cholesterol Reagent as a manual procedure is linear from 5 mg/dL to 750 mg/dL as shown by the recovery of linearity standards which procure is incearing in including in thigh comparing mean standard recoveries which the open the find failure into handles, shown below shown below. (HiChem Recoveries) = 3.7 mg/dL + 0.975 × (Standard Factors), r2 = 1.000 Sv.x = 4.11 mg/dL. df = 11 Precision, demonstrated by replicate assay of commercially available control sera, is shown below. | Specimen | n | mean | within-run SD | total SD | |-----------------|----|-----------|---------------|------------| | Serum control 1 | 29 | 109 mg/dL | 0.85 mg/dL | 0.92 mg/dL | | Serum control 2 | 30 | 226 mg/dL | 1.46 mg/dL | 1.90 mg/dL | | Serum control 2 | 30 | 501 mg/dL | 3.12 mg/dL | 4.47 mg/dL | Cholesterol recoveries of 113 mixed serum and plasma specimens are compared between the HiChem manual procedure and the Beckman® Cholesterol Read on the Synchron CX® Systems. Least squares regression statistics are shown below. Serum/ Plasma Comparisons: (HiChem Results) = 12 mg/dL + 0.957 × (Beckman® Results) r2 = 0.966 S(v.x) = 8.1 The use of the anticoagulants EDTA, citrate, oxalate, fluoride and heparin are shown to be acceptable chemical additives by comparison of spiked and unspiked serum pols. In all cases produced by the additive were less than 2.5 mg/dL cholesterol. The detection limit claim of 5 mg/dL is documented through the repetitive assay of a cholesterol standard. The observed detection limit, calculated as three standard deviations of a crowsition study, is 3.2 mg/dL and is below the claimed limit. 231 North Puente Street, Brea, California 92821 • (800) 733-4424 • (714) 871-8360 • FAX (714) 871-2439 ⁵¹⁰⁽k) Notification, HiChem Cholesterol Reagent Kit, p 74 {1}------------------------------------------------ The effectiveness of the HiChem secondary reagent application for the Beckman® SYNCHRON CX® Systems is shown by ilie recovery of linearity standards, the precision of control recovery of serum controls over both the calibration stability and on-board stability claims, the validation of the chemical additives and the comparison of patient specimen recoveries to the Beckman® SYNCHRON® Systems Cholesterol Reagent. The recovery of total cholesterol using the HiChem Cholesterol Reagent on the SYNCHRON CX® Systems is linear from 5 mg/dL to 750 mg/dL as shown by the recovery of linearity standards which span the claimed linear range. Regression statistics, comparing mean standard recoveries which open in oldniver in than it in really. In 010 to 918, are shown below. (HiChem Recoveries) = -1.0 mg/dL + 0.964 × (Standard Factors), sv.x = 8.9 ma/dL. df = 11 Precision, demonstrated by replicate assay of urine pools and commercially available control sera, is shown below. | Specimen | n | mean | within-run SD | total SD | |-----------------|----|-----------|---------------|-----------| | Serum control 1 | 60 | 105 mg/dL | 1.8 mg/dL | 1.4 mg/dL | | Serum control 2 | 60 | 217 mg/dL | 1.2 mg/dL | 2.5 mg/dL | | Serum control 3 | 60 | 504 mg/dL | 2.8 mg/dL | 2.5 mg/dL | Cholesterol recoveries of 154 mixed serum and plasma specimens are compared between the HiChem and Beckman® CHOL Reagents on the SYNCHRON CX® Systems. Least squares regression statistics are shown below. Serum/ Plasma Comparisons: (HiChem Results) = -3.6 mg/dL + 0.993 x (Beckman® Results) r2 = 0.983 S(y.x) = 6.1 The use of the anticoagulants EDTA, citrate, oxalate, fluoride and heparin are shown to be acceptable chemical additives by comparison of spiked and unspiked serum pools. In all cases, the bias due to the addition of anticoagulants is less than 1 mg/dL cholesterol and statistically insignificant. The detection limit claim of 5 mg/dL is documented through the repetitive assay of a cholesterol standard. The observed detection limit, calculated as three standard deviations of a 30 replicate study, is 2.7 mg/dL and is below the claimed limit. The 14 day onboard calibration stability and the 30 day on board reagent stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the changes in cholesterd recoveries over the test periods are lesse than 2.6% and less than the manufacturer's 3% within run precision claim for the SYNCHRON® Analyzer, The HiChem Cholesterol Reagent is substantially equivalent to the Beckman® SYNCHRON® Systems Cholesterol Reagent, product no. 467825, manufactured by Beckman® Instruments, Brea, CA. Wynn Starking Stocking Manager of Regulatory Affairs HiChem Diagnostics {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of 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 a caduceus, a symbol of medicine, with a staff and two snakes. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 AUG / 9 1998 Wynn Stocking · Manager, Regulatory Affairs HiChem Diagnostics 231 North Puente Street Brea, California 92821 Re : K982469 HiChem Cholesterol Reagent Regulatory Class: I Product Code: СНН Dated: July 14, 1998 Received: July 15, 1998 Dear Mr. Stocking: 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 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 (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, listing, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either 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 Requlations, Title 21, Parts 800 to 895. प्र substantially equip rate ar, fares out co 895. A the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (Q5) Tor Medical through poriodic of through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulations. Fran 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 requlations. {3}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-88), this device may require a CLTA complexity (CLA-88), this device may require a CLIA complexits categorization. To determine if it device a CLIA complexity can been for Disease Control if it does, your should contacts of 1988 the Centers for Disease Control if it does, your should contact (770), 199 assesse Control and Preventio the Centers for Disease Control if it does, you should con the Centers for Disease Control and Prevention (CDC) at This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification with described in your 510(k) premarket notification. The FDA first of substantial equivalence of your divine to a FDA manketed predicate device of your device to a legally marketed predicate device results in a classification a legally device and thus, permits your device to research and the provi the was producate device results in a classification for your device to proceed to the market. If you desire specific advice for your device on our exceller regulation (21 CFR Part 801 and additionally 000 consequence of regulation (21 CFR Part 801 and additionally 809.10 for in vice diagnostic devices), please contact the 0ffice of the promotion and advertising of vour devices of and first on the promotion and advertising of your device, pleases of the regulation entitled, "Misbranding of your device, contact on the regulation entitled, "Misbranding by reference to the resolution of the resolution of the resolution of the resolution of the research besto che information on your respo info a noonroad.com™ (21 CR 807.97). Other general obtained from the Division of Small Morefore of the more of your responsibilities under - end generati obtained from the Division of Small Manufacthe Armay Barance at its toll-free number (800) 638-2041 or (301) 443-6597 or at 11 11 0001 116e number (800) 638-2041 or (301) 443-6597 01 at its internet address "http://www.fda.gov/cdch/dsmanain.html". Sincerely yours, Steven Litman 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}------------------------------------------------ Page 1 of 1 510(k) Number (if known): K982469 Device Name: HiChem Cholesterol Reagent Kit . Indications For Use: HiChem Cholesterol Reagent is intended for the quantitative determination of total cholesterol in serum and plasma for the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This reagent is intended to be used in a professional setting or by trained personnel and is not intended for home use. .:- Respectfully. Wym Stocking Wynd Stocking Regulatory Affairs Manager HiChem Diagnostics 6 August, 1998 (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)