INVERNESS MEDICAL EARLY PREGNANCY TEST

{0}------------------------------------------------ DEC 1 8 2001 ## 510(k) Summary (As Required by 21 C.F.R. §807.92) k013907 Avril Murray, MSc. Submitted by: Product Development Manager Cambridge Diagnostics Ireland Limited Mervue Business Park Galway, Ireland. Phone 011 353 91 741976, Fax 011 353 91 752551 e-mail: avril.murray@cambridgediagnostics.ie Date of summary November 23, 2001 Inverness Medical™ Early Pregnancy Test Device name Common name Early Pregnancy Test Classification Name Regulation Number Classification names 862.1155(a) Kit, Test, Pregnancy, hCG, Over the Counter The modified device is substantially equivalent to the previously cleared Selfcare Predicate Device Early Pregnancy Test (K960436). The primary modifications are changes to the strip width and specimen sample Modifications size. Corresponding dimensional changes have been made to the housing to accommodate the narrower strip design. The modified device has the same intended use as the legally marketed predicate Intended Use device. The Inverness Medical™ Early Pregnancy Test is intended for use by lay consumers for the qualitative detection of hCG in urine as an aid in the detection of early pregnancy. Technological The modified device has the same technological characteristics as the legally marketed predicate device employing monoclonal antibodies for Characteristics immunochromatographic assay. Testing Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device. Testing involved safety testing from the risk analysis. Other evaluations included laboratory studies for repeatability, sensitivity, and interferences, and field evaluations for professional and consumer accuracy. Acceptance criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three curved lines representing its wings or feathers. The eagle is positioned within a circular frame, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 1 8 2001 Ms. Avril Murray MSc Product Development Manager Cambridge Diagnostics Ireland, Ltd. Mervue Industrial Estate Galway, Ireland Re: k013907 Trade/Device Name: The Inverness Medical™ Early Pregancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gondotropin (HCG) test system Regulatory Class: Class II Product Code: LCX; Dated: November 23, 2001 Received: November 26, 2001 Dear Ms. Murray: 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 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/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 {3}------------------------------------------------ ## 3.1 ODE Indications Statement ## Indications for Use Statement 510(k) Number KO13907 (if known) The Inverness Medical™ Early Pregnancy Test Device Name Indications for Use The Inverness Medical™ Early Pregnancy Test is intended for use by lay consumers for the qualitative detection of hCG in urine as an aid in the detection of early pregnancy. Thoman E. Dote Le Jean Cooper sion Sign-Off vision of Clinical Laboratory Devices Kol 3907 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