ABBOTT TESTPACK PLUS H. PYLORI

{0}------------------------------------------------ KC982362 NOV 1 8 1998 / ﻟﺴﻨﺎ ﺴﻴﺔ Section II 510(k) Summary . Abbott TestPack Plus H. pylori 510(k) July 1998 Hpsecii.lwp Volume I Section II {1}------------------------------------------------ ## 510(k) Summary Abbott TestPack® Plus™ H. pylori # Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination The following information as presented in the Premarket Notification [510(k)] for the Abbott TestPack Plus H. pylori assay constitutes data supporting a substantially equivalent determination. Abbott TestPack Plus H. pylori is a rapid, visually read, qualitative immunoassay for the detection of human IgG antibodies specific to Helicobacter pylori in human serum, plasma, or whole blood. The assay is intended for use by health professionals as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease. There are two kit configurations associated with the Abbott TestPack Plus H. pylori assay, one where the intended use is for testing serum, plasma, venous whole blood, and fingerstick whole blood specimens and a second where the intended use is for testing whole blood specimens collected by fingerstick or venipuncture. Substantial equivalence has been demonstrated between the Abbott TestPack Plus H. pylori assay and the HM-CAPm Helicobacter pylori Enzyme Immunoassay for the detection of H. pylori specific IgG antibodies. The intended use of the HM-CAP assay is for the qualitative detection of IgG antibody to H. pylori in human serum and it is used as an adjunct in the diagnosis of infection by H. pylori. Fresh serum specimens were obtained from 107 symptomatic patients undergoing endoscopic examination at two clinical sites. Forty nine (49) specimens were tested at one site, of which four were excluded from the analysis because the biopsy test results were indeterminate for H. pylori infection. The sensitivity and specificity were 90.9% (10/11) (95% C.I. of 58.7% to 99.8%) and 76.5% (26/34) (95% C.I. of 58.8% to 89.3%), respectively. The presence of H. pylori specific IgG antibodies in all eight TestPack {2}------------------------------------------------ positive and biopsy negative specimens from this site were detected by the HM-CAP assay. Fifty eight (58) specimens were tested and analyzed at the second site resulting in a sensitivity and specificity of 70.8% (17/24) (95% C.I. of 48.9% to 87.4%) and 88.2% (30/34) (95% C.I. of 72.6% to 96.7%), respectively. The presence of H. pylori specific IgG antibodies in all four TestPack positive and biopsy negative specimens from this second site was detected by the HM-CAP assay. Similarly, the absence of H. pylori specific IgG antibodies in two of seven TestPack negative and biopsy positive specimens was observed by the HM-CAP assay. A comparison was made with the TestPack assay to biopsy and the HM-CAP assay using 135 previously characterized serum specimens. (Refer to Table 1.) Two of the 135 specimens were HM-CAP indeterminate and not used in the TestPack to HM-CAP analysis. (Refer to Table 2.) | Table 1 | |---------------------------------------| | Abbott TestPack Plus <i>H. pylori</i> | | Compared to Biopsy | | n | Agreement | Sensitivity<br>(95% C.I.) | Specificity<br>(95% C.I.) | |-----|-----------------|------------------------------------|-----------------------------------| | 135 | 92.0% (124/135) | 92.3% (96/104)<br>(85.4% to 96.6%) | 90.3% (28/31)<br>(74.3% to 98.0%) | ### Table 2 Abbott TestPack Plus H. pylori Compared to HM-CAP | n | Relative<br>Agreement | Relative Sensitivity<br>(95% C.I.) | Relative Specificity<br>(95% C.I.) | |-----|-----------------------|------------------------------------|------------------------------------| | 133 | 94.0% (125/133) | 95.0% (96/101)<br>(88.8% to 98.4%) | 90.6% (29/32)<br>(75.0% to 98.0%) | Abbott TestPack Plus H. pylori 510(k) July 1998 Hpsecii lwp {3}------------------------------------------------ In conclusion, these data demonstrate that the Abbott TestPack Plus H. pylori assay is as safe and effective as, and is substantially equivalent to, the HM-CAP Helicobacter pylori Enzyme Immunoassay. Prepared and Submitted July 2, 1998 by: Abbott Laboratories Irene Powers ← Regulatory Section Leader ADD Regulatory Affairs 1-847-937-1998 200 Abbott Park Road Abbott Park, IL 60064-3537 {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. ### NOV 1 8 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Irene Powers Section Leader - Devices ADD Regulatory Affairs Dept. 9V6, Building AP31 200 Abbott Park Road Abbott Park, Illinois 60060-3537 Re : K982362/S1 Abbott TestPack® Plus™ H.pylori Trade Name: Requlatory Class: I Product Code: LYR Dated: September 24, 1998 Received: September 25, 1998 Dear Ms. Powers: 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. 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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. {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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.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 {6}------------------------------------------------ 510(k) Number (if known): K982362 Device Name: Abbott TestPack® Plus™ H. pylori Indications For Use: The Abbott TestPack®Plus™ H. pylori assay is a rapid, visually read, qualitative immunoassay for the detection of human IgG antibodies specific to Helicobacter pylori in serum, plasma, and whole blood specimens from symptomatic adults. #### Reference: 1 - 1. McGuigan JE. Peptic Ulcer and Gastritis. In: Harrison's Priniciples of Internal Medicine, 12th Edition, New York: McGraw-Hill, 1991:1229-1248. Woody Dubres 510/k) Number (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) OR Over-The-Counter Use - - - (Optional Format 1-2-96)