AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK

{0}------------------------------------------------ K974027 ## 510(k) Premarket Notification Alfa Biotech (UK) Ltd AuraFlex® FT3 ## 10.0 510(K) SUMMARY ## FEB - 2 1998 A 510(k) Summary follows for the AuraFlex® FT3 reagents described in this submission. 510(k) Summary AuraFlex® FT3 12.05. This summary and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. Submitter's Name: Alfa Biotech (UK) Ltd Submitter's Address: Unit 4, Spring Lakes Estate, Deadbrook Lane, Aldershot, Hants, GU12 4UH Submitter's Telephone: (44) 1252 341477 Submitter's Contact: Mr M John Taylor Date 510(k) Summary Prepared: September 26, 1997 Device Trade or Proprietary Name: AuraFlex® FT3 Device Common or Usual Name: Immunoassay for free triiodothyronine Device Classification Name: Free triiodothyronine Test System Device Description: Fluorescent immunoassay reagents. Device Intended Use: The AuraFlex® FT3 assay is a fluorescent immunoassay for the quantitative determination of free triiodothyronine assay in human serum or plasma using the AuraFlex® System. ## Data Upon Which Substantial Equivalence was Determined: A comparison study was conducted in which 110 human serum samples were assayed using the AuraFlex® FT3 assay in singlicate. Results between the two assays showed a correlation of 0.9 (AuraFlex* FT3 = 0.93 Other FT3 assay +0.2pg/ml (0.3 pmoV1). {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three heads, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 FEB - 2 1998 M. John Taylor . Director of Quality and Regulatory Affairs Alfa Biotech (UK) Ltd. 4 Spring Lakes Estate Deadbrook Lane Aldershot Hants GU12 4UH Re : K974027 AuraFlex® FT3 Requlatory Class: II Product Code: CDP January 21, 1998 Dated: Received: January 21, 1998 Dear Mr. Taylor: 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, labeling, 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. Existinq major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ 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 Druq 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 requlations. {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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Steven Bitman 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}------------------------------------------------ | 510(k) Number (if known): | K974027 | |---------------------------|--------------| | Device Name: | AURAFLEX FT3 | Page ___ of ___Indications for Use: AuraFlex FT3 employs a fluorescent enzyme immunometric assay technology for the quantitative determination of free triodothyronine (FT-) in human serum or plasma using the AuraFlex system. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use_ (Per 21 CFR 801. 109) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Optional Format 1-2-96) (Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number K974027