MYSET PREGNANCY TEST

{0}------------------------------------------------ K 053/38 #### MAR I 2006 # 510 (k) SUMMARY Date of Summary: February 24, 2006 #### Product Name: MySet™ Pregnancy Test #### Sponsor: Ani Biotech Oy Tiilitie 3, 01720 Vantaa, Finland ### Correspondent: MDC Associates Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915 (978)-927-3808 # Substantially Equivalent Devices: Product: True® 20 One-Step Pregnancy Test Manufactured by: Stanbio Laboratory #### PRODUCT DESCRIPTION: The MySet™ Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The MySet™ Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. #### INTENDED USE: The MySet™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Over-The-Counter Use. # SUMMARY OF TECHNOLOGY: The One-Step Pregnancy Test employs a unique combination of monoclonal-dye conjugate and mouse monoclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine. As the urine sample flows through the absorbent portion of the device, the antibody-dye conjugate binds to the hCG forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a red color band if hCG concentration is equal to or greater than 25 mIU/ml. In the absence of hCG, there is no line in the reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a red color band, demonstrating that the test is functioning correctly. {1}------------------------------------------------ # PERFORMANCE DATA: A method comparison was done to compare the performance of the MySet™ Pregnancy Test to a FDA cleared product. These data clearly demonstrate the performance of the MySet™ Pregnancy Test by Ani Biotech Oy is substantially equivalent to a commercially available FDA cleared pregnancy test: Stanbio True® 20 One-Step Pregnancy Test (K980531) Agreement: 100% # STATEMENT OF SAFETY AND EFFICACY: The MySet™ Pregnancy Test when compared with another commonly used pregnancy test (Stanbio True 20-K980531) demonstrated 100% performance. These data clearly demonstrate the safety and efficacy of the MySet™ Pregnancy Test and further confirm that the accuracy of this product when compared to a substantially equivalent device currently being sold. Testing by untrained women of childbearing years confirmed that the test can be effectively performed by untrained individuals. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted in a minimalist, abstract design. Public Health Service MAR I 2006 Food and Drug Administration 2098 Gaither Road Rockville MD 20130 Ani Biotech Ov c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915 Re: k053138 > Trade/Device Name: MySet™ Pregnancy Test Regulation Number: 21 CFR8862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: January 14, 2006 Received: January 17, 2006 Dear Ms. White: 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {3}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours, Alberto G Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K053138 MySet™ Pregnancy Test Device Name: The MySet™ Pregnancy Test is a test for the qualitative Indications For Use: determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. For Over-the-Counter Use. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use V (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | Division Sign-Off | | |--------------------------------------|---------| | Office of In Vitro Diagnostic Device | | | | | | | k053138 | Page 1 of 1