AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)

{0}------------------------------------------------ 1 2002 NOV 16022680 # 510(k) SUMMARY DEVICE NAME: AZOG,Inc. Urine Pregnancy Test Strip (DipStick). | APPLICANT NAME: | AZOG, Inc. 1011 US HWY 22 WEST PHILLIPSBURG, NJ 08865 | |-----------------|-----------------------------------------------------------| | CONTACT: | AZUBUIKE OGALA Tel.: (908) 213-2900 Fax: (908) 213-2901 | # INTENDED USE: The AZOG hCG One-Step (Urine) Pregnancy Test Strip (DipStick) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. # DESCRIPTION OF THE DEVICE The AZOG hCG One-Step Pregnancy Test Strip (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by immersing the test strip in a urine specimen and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly. 45 AZOG, Inc. hCG One-Step Urine Pregnancy Test Strip (DipStick) {1}------------------------------------------------ # DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE: # Assay Precision/Tolerance An evaluation of AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick) was conducted using a panel of 3 coded specimens. The proficiency panel contained negative, low positive and high positive specimens. Two different operators tested each level in replicates of five over a period of three days. No differences were observed within run (5 replicates), between runs (three different assay days), or between operators (two operators). ### Correlation A total of 150 urine specimens were tested using the AZOG, Inc. hCO One-Step Urine Pregnancy Test (DipStick). When these results were compared to results obtained from a similar device, the result demonstrated 100% overall agreement (for an accuracy of greater than or equal to 99%) of the AZOG, Inc. bCG One-Step Urine Pregnancy Test (DipStick). #### Sensitivity and Specificity The AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick) detects hCG at 25 mlU/mL or greater. The test has been standardized to the W.H.O. Third International Standard. The addition of LH (1000 mIU/mL), FSH (1000 mIU/mL) and TSH (1000 µIU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) specimens showed no cross-reactivity. #### Interference Study None of the potentially interfering substances tested interfered in the AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick)assay. AZOG, Inc. bCG One-Step Urine Preguancy Test Strip (DipStick) {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVIC Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three curved lines representing the eagle's wings and three wavy lines representing the eagle's body. 18 Garner Road Mr. Azubuike Ogala President/V.P., Research & Development Azog Incorporated 1011 US HWY 22 Phillipsburg, NJ 08865 > k022680 Trade/Device Name: ACG One-Step Urine Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: DHA Dated: August 1, 2002 Received: August 12, 2002 Dear Mr. Ogala: Re: 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ #### 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" (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/cdrl/dsmaldsmamain.html". Sincerely yours, Steven Butman 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 {4}------------------------------------------------ 022680 510(k) Number (if known): Device Name: hCG ONE-STEP GNANC Indications For Use: AZOG, INC. ACG one-step. Vrine Pregnancy test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human Urine the test is for professional use only. (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K022680 (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) OK Over-The-Counter Use_ · of (Optional Format 1-2-96) SK47