TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113

{0}------------------------------------------------ **Thermo DMA** 845 Avenue G East Arlington, TX 76011-7709 ## 510 (k) Sumary (817)607-1700 Fax: (817) 649-2461 www.thermodma.com This Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Submitter: Thermo DMA, Inc. Address: 845 Avenue G East Arlington, Texas 76011 Contact Person: Thomas Dollar, Manager of Regulatory Affairs The assigned 510(k) number is KOI2SIB Product Code: CJE, Alkaline Phosphatase or isoenzymes test system Device Name: TRACE Scientific Alkaline Phosphatase, Two-Part Liquid Assay Device Class: II Predicate Device: Roche Diagnostics Alkaline Phosphatase Description and Intended Use: TRACE Scientifics' alkaline phosphatase reagents are intended for the in vitro quantitative determination of alkaline phosphatase in human serum and plasma. ## Clinical Significance ¹ : Human alkaline Phosphatase (ALP) consists of a group of enzymes (at least five) which hydrolyze phosphates at an alkaline pH (6-8). ALP is found in practically all tissues of the body but in high concentrations in the osteoblasts of bone, liver, placenta, kidney, intestinal wall and lactating mammary glands. In adults, the ALP normally found circulating in the serum is largely derived from the liver. In children or in adolescents going through pubertal growth spurts there is an additional contribution from bone and this accounts for the higher reference interval for these groups. Pregnancy also raises the normal values of ALP. Increased ALP (usually normal GGT) is seen in Osteomalacia and Rickets, primary hyperparathyroidism with bone involvement, Pagets disease, secondary carcinoma in bone and some cases of osteogenic sarcoma. Increased levels of ALP (usually with a raised GGT) is seen in cholestasis, hepatitis, cirrhosis, space occupying lesions and malignancy with bone or liver involvement or direct production. Low levels of ALP may be observed in conditions which cause arrested bone growth or in hypophosphatasia. #### Methodology: A Thermo Electron business The TRACE ALP - AMP (IFCC) method is based on the recommendations of the International Federation of Clinical Chemistry (IFCC) . This method utilizes 4-nitrophenylphosphate (4-NPP) as the substrate. Under the optimized conditions ALP present in the sample catalyses the following transphosphorylation reaction. {1}------------------------------------------------ At the pH of the reaction 4-NPP has an intense yellow color. The reagent also At the ph of the redeced i system to ensure that optimal concentrations of concurns a mood as a re maintained. The metal ion buffer can also chelate other potentially inhibitory ions, which may be present. The reaction is other potentially innibilory active in absorbance at 405 nm, which is proportional to the activity of ALP in the serum. Method Comparison: Comparison studies were carried out on an automated clinical chemistry analyzer(Hitachi 911). Serum samples were assayed in cirnical onemably compared by the least regression method. The following statistics were obtained; Number of Sample Pairs: 60 Range of Sample Results: 48 - 225 U/L Mean of Results (Roche): 100 U/L Mean of Results (TRACE Scientific): 105 U/L Slope: 1.03 Intercept: -0.33 Correlation Coefficient: 0.9997 ## Precision: ### Within Run | | Level 1 | Level 2 | |-----------------------|---------|---------| | Number of Data Points | 40 | 40 | | Mean (U/L) | 74 | 319 | | SD (U/L) | 0.65 | 2.02 | | CV (%) | 0.9% | 0.6% | | Total | | | | | Level 1 | Level 2 | | Number of Samples | 40 | 40 | | Mean (U/L) | 74 | 319 | | SD (mmol/L) | 2.58 | 9.34 | | CV (%) | 3.5% | 2.9% | Sensitivity: The TRACE Scientific Alkaline Phosphatase reagent assay has a sensitivity of 0.4 AmAbs/min per U/L. Reportable Range: Linearity studies conducted by TRACE Scientific demonstrated acceptable performance up to 2000 U/L. {2}------------------------------------------------ Specificity: Interference studies conducted by TRACE Scientific determined the following; - 1. Free Bilirubin interference No interference from bilirubin up to 16.3 mg/dL - 2 10.5 mg/an No interference from bilirubin up to 17.1 mq/dL - Hemoglobin interference No interference from hemoglobin up to 790 mg/dL - 4. Lipemia: When measured bichromatically, no interference from lipemia, measured as triglycerides, up to 2000 mg/dL. ### Reference Ranges : At 37° C | Age Group | Sex | Range | |-----------|---------|--------------| | 20 - 50 | Males | 53 - 128 U/L | | 20 - 50 | Females | 42 - 98 U/L | | > 60 | Males | 56 - 119 U/L | | > 60 | Females | 53 - 141 U/L | Conclusion: Analysis of the comparative measurements presented in the 510(k) submission for this reagent, together with linearity and precision data Submission for this reagons, omonstrates the TRACE Alkaline Phosphatase assay corrected in actu problem anificant differences exist between the results obtained on samples analyzed utilizing the TRACE Scientific Alkaline obtained on beaps on those obtained when utilizing the predicate device in these studies. ## References: - 1. Zilva JF, Pannall PR, "Plasma Enzymes in Diagnosis" in Clinical Diagnosis and Treatment. Lloyd London 1979:Chap 15 343. - IFCC method for the measurement of ALP J Clin Chem Clin Biochem 1983: 21:73 I-48. - 3. Tietz Textbook of Clinical Chemistry, Second Edition, WB Saunders 1994;830-843. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT - 9 2001 Mr. Thomas Dollar Manager of Regulatory Affairs Thermo DMA 845 Avenue G East Arlington, TX 76011-7709 k012518 Re: Trade/Device Name: TRACE Scientific Alkaline Phosphatase Assay Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CJE Dated: August 3, 2001 Received: August 6, 2001 Dear Mr. Dollar: 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. {4}------------------------------------------------ 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 notification. The I Dri intellig of sussion 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 additionally 809.10 for in True chaghestions on the promotion and advertising of your device, (301) 594-4566. Rudinonally, 201 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 Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers International and Solless "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Gutman 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the words "Thermo DMA" in a bold, sans-serif font. The word "Thermo" is larger than the letters "DMA". The letters are black against a white background. A Thermo Electron business 845 Avenue G East Arlington, Texas 76011-7709 USA Telephone 817/607-1700 # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): ½012518 ____________________________________________________________________________________________________________________________________________ Device Name: TRACE Scientific Alkaline Phosphatase Assay Indications For Use: This reagent is intended for the in vitro quantitative determination of Alkaline Phosphatase in human serum and plasma. Measurements of Alkaline Phosphatase or its isoenzymes are used as in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases. (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 | K012518 | |---------------|---------| |---------------|---------| | Prescription Use | <div> <img alt="Check Mark" src="check_mark.jpg"/> </div> | OR | Over-The-Counter Use | |------------------|-----------------------------------------------------------|----|----------------------| |------------------|-----------------------------------------------------------|----|----------------------| (Per 21 CFR 801.109) (Optional Format 1-2-96)