VICTORCH HCG TEST STRIP

{0}------------------------------------------------ 510k Submission for # VicTorch Meditek, Inc. Human Chorionic Gonadotrophin (hCG) Urinary Pregnancy Test Strip Device VicTorch Meditek, Inc. DEC 2 7 2001 ( 0) 370 Revision B, September 19, 2001 / ## SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS The VicTorch hCG Test Strip device is a lateral flow qualitative color-conjugated immunochromatographic (CCI) in vitro diagnostic (IVD) assay for human Chorionic Gonadotropin (hCG) at the cutoff level of 20 mlU/ml of human urine, for detection of early pregnancy as commonly used by professionals. Measurements obtained by the qualitative VicTorch hCG Test Strips are used to aid in the diagnosis of pregnancy. VicTorch hCG Test Strip devices are classified as Class II Devices, as described in Section 21 CFR 862.1155 Human Chorionic Gonadotropin (hCG) Test Systems, having product code: 91 DHA. These VicTorch hCG Test Strip devices are IVD tests designed to give rapid, visual, qualitative results and are intended for professional use only. VicTorch hCG Test Strip devices are not intended for quantitative results, nor for over-the-counter sales. The VicTorch hCG Test Strips provide only preliminary analytical data. A more specific alternative clinical method must be used to obtain a confirmed analytical result. In order to determine if the VicTorch hCG Test Strip devices can function as effectively as other FDA approved and currently marketed similar hCG test devices (such as ABI's SureStrip™ hCG strip devices), a number of evaluation studies were done with the VicTorch hCG Test Strips as listed herein. These studies included: (1) Sensitivity studies that includes 20% above and below 20 mlU hCG/ml cutoff concentration and other 0 to 100 mlU hCG/ml levels that indicated the VicTorch hCG Test Strip can consistently detect 20 mlU hCG /ml or greater hCG in human urine as it claimed. (2) Specificity studies against other structurally related hormones such as 500 mlU/ml of LH, 1000 µlU/ml of TSH, and 1000 mlU/ml of FSH that shown that these hormones do not cross-react with the VicTorch hCG Test Strip at the indicated test levels. (3) Interference studies against analytes commonly found in OTC, prescription and/or abuse drugs proved that those drugs, chemical analytes, and pH (varied within normal range for human urine) did not interfere VicTorch hCG Test Strip performance, vielding no false positive or false negative results. (4) The Specimens Collection and Storage studies on both hCG negative and hCG positive urine specimens validated the VicTorch hCG Test Strip devices when tested for urine specimens refrigerated for up to three days. (5) Accuracy studies at an external OBGYN clinical center on 172 female patients (with 91 hCG positive and 81 hCG negative) gave complete agreement (accuracy = 100%) with the ABI's SureStrip™ hCG Test, the predicate approved hCG assay device. (6) In house stability study for both accelerated and real time evaluations showed that the performance of VicTorch hCG Test Strip was stable for at least one year from the time of being manufactured. Support data collected from the above evaluation and accuracy studies (i.e., Relative Accuracy = Total # of VicTorch hCG Test Strip agreed with SureStrip™ / Total # of ABI SureStrip™ tested x 100% = 172/172 x 100% = 100%, with at 95% Confidence = 99.1-99.8%) indicate substantial equivalence of this newly designed VicTorch hCG Strip with the predicate approved hCG assay device. We can conclude that VicTorch hCG Test Strip devices are substantially equivalent to currently marketed ABI's SureStrip™ hCG pregnancy rapid tests devices for professional use qualitative urinary assay of hCG at the required cut-off of 20 mlU/mL. Additional information on this submission may be obtained by contacting: Dr. Pierce Liu, President, at VicTorch Meditek, Inc, via Tel.: (858)-530-9191, Fax: (858)-530-9192, Email: Vtorch99@aol.com. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine, with three intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 VicTorch Meditek, Inc. c/o Raymond Wilson, Pharm. D. California Department of Health 714/744 P Street P.O. Box 942732 (MS-357) Sacramento, CA 94234-7320 DEC 2 7 2001 Re: k013702 Trade/Device Name: VicTorch Meditek, Inc Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Strip Device (VicTorch hCG Test Strip Device) Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (hCG) test system Regulatory Class: Class II Product Code: JHI Dated: December 12, 2001 Received: December 13, 2001 Dear Dr. Wilson: 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. {2}------------------------------------------------ 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 DI Incation 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 If you desire specific active to your care devices), please contact the Office of Compliance at additionally 607.10 for millionally, for questions on the promotion and advertising of your device, (301) 594-4560. Addidonally) for "quice at (301) 594-4639. Also, please note the regulation 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 mionination on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/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 {3}------------------------------------------------ ### 510k Submission for VicTorch Meditek, Inc. Human Chorionic Gonadotrophin (hCG) Urinary Pregnancy Test Strip Device VicTorch Meditek, Inc. Proprietary Information Revision B. September 19, 2001 ldentity of the Classification: 21 CFR 862.1155; Product Code: DHA Device Name: VicTorch Meditek, Inc. Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Strip Device # INDICATIONS FOR USE STATEMENT: The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Strip device (also rne vioron moditor Haman Sherion's designed as a rapid in vitro diagnostic (IVD) qualitative lateral flow color-conjugated immuno-chromatographic (CCI) assay for the early detection of pregnancy, now done ourick direct visual test for the placental hormone, hCG, at the required cut-off level of 20 mlU hCGml of human urine. VicTorch hCG Test Strip devices are intended to meet all requirements for rioUing rapid, easily read, qualitative results for the purpose of early pregnancy detection via CCI assay of ylolang rapid, outlif rodal quality of the may be present in human plasma or urine, according to the requirements set forth in Title 21, section 862.1155 of the Code of Federal Regulation or CFR, and in subsequent federal Guidance Documents. VicTorch hCG Test Strip devices are not intended for quantitative results, nor for over the counter (OTC) sales. VicTorch hCG Test Strip devices are designed for professional use nor of of of of over to over (viran analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) #### Concurrence of CDRH, Office of Device Evaluation (ODE) Lean Cooges. (Division Sign-Off Division of Clin Ces 510(k) Number K013702 Prescription Use: (Per 21 CFR 801.109) or Over-the-Counter Use: (Optional Format 1-2-96)