GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05

{0}------------------------------------------------ FEB 16 2000 K9933332 ## GRADIPLASMA LA HIGH AND LOW PREMARKET NOTIFICATION 510(K) SUMMARY (Summary of Safety and Effectiveness) | Submitter: | Rhonda Pilgrim<br>Regulatory Affairs Manager<br>Gradipore Ltd<br>Lot 16 Riverside Corporate Park<br>35 - 105 Delhi Rd, North Ryde 2113<br>Australia<br>1800 762 2620<br>Fax (612) 9805 0624 | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Rhonda Pilgrim<br>1800 762 2620 | | Date Prepared: | January 17, 2000 | | Trade Name: | GradiPlasma LA High and Low | | Common or Usual Name: | Lupus Anticoagulant Quality Control Plasmas | | Classification Name: | Control, Plasma, Abnormal<br>Per 21CFR section 864.7925, Class II | | Equivalent Device: | Verify® LA Control, K961370 | #### Description of the device / intended use: GradiPlasma LA High and Low are preparations of fresh human citrated plasma with added buffers and stabilizers, for in vitro diagnostic use. The controls are prepared from patients diagnosed with Lupus Anticoagulant and lyophilized in two levels (High and Low) and two volumes (0.5ml and 1.0ml). GradiPlasma LA High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore. GradiPlasma LA Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore. Validation studies for the GradiPlasma LA High and GradiPlasma LA Low have been performed using IL ACL300, IL MLA 800 and Dade Behring BCT instruments. Image /page/0/Picture/8 description: The image shows the words "Gradipore" and "ORIGINAL" stacked on top of each other. Below that, the words "(if in red)" are written. The text appears to be part of a document or label, possibly indicating the authenticity or original status of a product. {1}------------------------------------------------ #### 510(k) Premarket Notification - Additional Information Gradipore LTD GradiPlasma LA High and Low K993332 ## Statement of how the technological characteristics of the Device compare to the predicate device GradiPlasma LA High and Low were compared against Organon Teknika's Verify® LA Control, a 510(k) cleared device. Both devices are unassayed in vitro diagnostic controls prepared by lyophilization of known positive lupus anticoagulant patients, with added buffers and stabilizers. Both controls are intended for use in dilute Russell's Viper Venom Time test systems such as LA SCREEN (DRVVT) with phospholipid neutralization tests such as LA CONFIRM (DRVVT). The Verify® LA Control is a single level control whereas the GradiPlasma LA has both a high and low level. Each level of GradiPlasma LA is available in 10 X 0.5ml and 10 X 1.0ml volumes while the Verify® LA Control is available only in 10 X 0.5ml. ### Summary of Performance Data In a comparative performance study on an IL MLA800 instrument, the GradiPlasma LA High and GradiPlasma LA Low exhibited similar within-run variance to the predicate device, Verify® LA Control. Within-run %CV for both levels of GradiPlasma was well below specifications (5%). GradiPlasma LA High gave 1.7% CV with LA SCREEN and 1.4% with LA CONFIRM; GradiPlasma LA Low gave 0.8% with LA SCREEN and 0.9% with LA CONFIRM, while the predicate Verify® LA Control gave 0.8% with LA SCREEN and 2.3% with LA CONFIRM. In a study comparing reconstituted stability of the devices using a Dade Behring BCT analyzer the GradiPlasma LA High and Low were stable for 8 hours at 2-8℃ and were able to be freeze thawed once. The Verify® LA was also stable for 8 hours at 2-8°C. ### Conclusion Based on the data provided, Gradipore concludes that GradiPlasma LA High and Low are substantially equivalent to the predicate device, Verify® LA Control in overall performance characteristics, intended use, safety and effectiveness. The one new performance characteristic of the GradiPlasma LA, (two levels of control), is designed to provide a more comprehensive set of controls for lupus anticoagulant testing. | Gradipore | |-------------| | ORIGINAL | | (if in red) | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered in the image and is the only element present. FEB 1 6 2000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Rhonda Pilgrim Regulatory Affairs Manager Gradipore Limited Lot 16 Riverside Corporate Park 35-105 Delhi Road, North Ryde 2113 AUSTRALIA Re: K993332 Trade Name: GradiPlasma LA High and Low Regulatory Class: II Product Code: GGC Dated: January 17, 2000 Received: January 19, 2000 Dear Ms. Pilgrim: 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 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). 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 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 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. 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 regulations. {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 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 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}------------------------------------------------ # INTENDED USE STATEMENT 510(k) Number (If known): 993332 Device Names: GradiPlasma LA-High and GradiPlasma LA - Low Indications For Use: GradiPlasma LA High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore. GradiPlasma LA Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore. Validation studies for the GradiPlasma LA High and GradiPlasma LA Low have been performed using IL ACL300, IL MLA 800 and Dade Behring BCT instruments. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|----------------------------------------------| | | <img alt="Signature" src="signature.png"/> | | (Division Sign-Off) | | | Division of Clinical Laboratory Devices | | | 510(k) Number | K993332 | | Prescription Use | <img alt="Check Mark" src="check_mark.png"/> | | (Per 21 CFR 801.109) | | | OR | Over-The-Counter Use | | | (Optional Format 1-2-96) | | 1 - 1987 - 1984 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----| | .<br>2006 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1<br>- 3 82<br>. | | | 2 8 8<br>ﺔ ﺍﻟﺘ | AXP | | 2 5 % | | | Personal program and the mail of the mail of the production of the service of the send the service of the | |