PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "DADE" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The letters are evenly spaced and aligned horizontally. KA73100 SEP 2 9 1997 ## DADE INTERNATIONAL Chemistry Systems P.O. Box 6101 Newark, DE 19714 Summary of Safety and Effectiveness Information This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | Submitter's Name: | Rebecca S. Ayash<br>Dade International Inc.<br>Building 500, Mailbox 514<br>P.O. Box 6101<br>Newark, DE 19714-6101 | |----------------------|--------------------------------------------------------------------------------------------------------------------| | Date of Preparation: | 8/15/97 | | Device Name: | Prostate Specific Antigen (PSA) Calibrator | | Classification Name: | Calibrator, Secondary | | Predicate Device: | aca® plus Prostate Specific Antigen Calibrator | Device Description: Prostate Specific Antigen (PSA) Calibrator for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is a frozen product. The Level 1 calibrator is horse serum based with no detectable PSA. Levels 2 through 5 contain human PSA-ACT in a bovine serum albumin base. The kit consists of ten vials; two at each of five levels, containing 1 mL each. Intended Use: PSA Calibrator is intended to be used to calibrate the PSA method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module. ## Comparison to Predicate Device: | | Dimension® RxL PSA Calibrator | aca® plus PSA Calibrator | |--------------|-------------------------------|------------------------------| | Intended Use | Calibrator | Calibrator | | Analyte | PSA-ACT | PSA-ACT | | Matrix | L-1 horse serum<br>L-2-5 BSA | L-1 horse serum<br>L-2-3 BSA | | Form | frozen | liquid | | Volume | 1.0 mL per vial | 3.0 mL per vial | | Levels | 5 levels | 3 levels | {1}------------------------------------------------ ## Comments on Substantial Equivalence: Both the PSA Calibrator for the Dimension® RxL system and the aca® plus PSA Calibrator are manufactured using the same matrices and contain PSA-ACT as the analyte source. Both products are intended to be used as calibrators for prostate specific antigen assays. Conclusion: PSA Calibrator for the Dimension® RxL system is substantially equivalent to the aca® plus PSA Calibrator based on the comparison summarized above. Rebecca Slayden Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 8/15/97 {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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three tail feathers. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Rebecca S. Ayash Requlatory Affairs and Compliance Manager Dade International Inc. Building 500, mailbox 514 P.O. Box 6101 Newark, DE 19714-6101 SEP 2 9 1997 Re: K973100 Trade Name: Prostate Specific Antigen (PSA) Calibrator Requlatory Class: II Product Code: JIT Dated: August 15, 1997 Received: August 19, 1997 Dear Ms. Ayash: 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. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug 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. this response to your premarket notification Please note: 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 regulations. {3}------------------------------------------------ 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 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" (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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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 {4}------------------------------------------------ ## Indications Statement Device Name: Prostate Specific Antigen (PSA) Calibrator Indications for Use: The PSA Calibrator is an in vitro diagnostic product intended to be used to calibrate the Prostate Specific Antigen (PSA) method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassy module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method. Rebecca Scapph Rebecca S. Ayas Regulatory Affairs and Compliance Manager Date: 9/25/97 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) נ K 973100 (510(k) Number Victor E. Macher Division Sign-Off Office of Device Evaluation Prescription Use ✓