PYLORI DETECT IGG

{0}------------------------------------------------ ## MAR 1 0 1998 ## SUMMARY OF 510 (k) SAFETY AND EFFECTIVENESS INFORMATION This summary of 510 (k) safety and effectivencss information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92. Micro Detect, Inc. PYLORI DETECT IgG reagents (P/Nxxxxxxx) is intended for the qualitative determination of IgG antibodies to H pylori in human serum. The principal diagnostic value of the presence of these antibodies in serum is detection of H. pylori intection, which is used as an aid in patients with Peptic and Duodenal ulcers. The Micro Detect, Inc. H. pylori reagent ( PYLORI DETECT IgG) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific autigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution. The patient results obtained using the PYLORI JJHTF.CT IgG are substantially equivalent to those obtained by endoscopic evaluations: | Sensitivity: | 98.3% | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Specificity: | 94.4 % | | Positive predictive value: | 97.0 % | | Negative predictive value: 96.7 % | | | Accuracy: | વેર જે જે જે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી | Precision: 1.39-5.91(Inter) and 4.35-6.86(Intra) Stability: One year at 2-8°C. The stability of the PYLORI DETECT IgG Kit for the detection of IgG antibodies to H pylori was found to be one year at 2-8°C. This was predicted from studies done under stress condition (37°C). Real time stability is being monitored at 2-8°C. The Micro plate ELISA formats is a commonly used formal for the detection of many entities of clinical interest, including infectious diseases. The PYLORI DETECT IgG assay system is shown to be safe and effective and provide patients results which are substantially equivalent to those obtained by endoscopic cvaluations. {1}------------------------------------------------ MAR 1 0 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mehdi Alem, Ph.D. General Manager Micro Detect, Inc. 23016 Del Lago Dr., Suite B Laguna Hills, CA 92653 Re: K973508 Trade Name: Pylori Detect IgG Regulatory Class: I Product Code: LYR - ---Dated: December 19, 1997 Received: December 29, 1997 Dear Dr. Alem: 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). 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, labeline, 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 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to 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. Image /page/1/Picture/9 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle. {2}------------------------------------------------ ## Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655. 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" Sincerely vours. Steven Autman 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 {3}------------------------------------------------ K973508/A' Page 1 of 1 K97350 8 510(k) Number (if known):___ PYLORI DETECT Device Name:_ IGG Indications For Use: The PYLORI DETECT IgG is a quallefative Enzyme Immunoassay( EIA) Kit for the detection of IgG antibodies against H. pylori in human serum. The test is intended as an aid in the diagnosis of infection by H. puber in The test is intended as an aid in the diagnosis of infection by H. pylori in patients with gastroned as an aid in the diagnosis of infection by H. pylori in patients with gastronestinal symptoms. FOR IN VITRO DIAGNOSTIC USE ONLY. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <div></div> <div>(Division Sign-Off)</div> | |---------------|--------------------------------------------| | | Division of Clinical Laboratory Devices | | 510(k) Number | K973508 | | Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use | |------------------------------------------|----|----------------------| |------------------------------------------|----|----------------------| (Optional Format 1-2-96)