VFE

{0}------------------------------------------------ OCT 22 1998 Image /page/0/Picture/1 description: The image shows the logo for Ramco Laboratories Inc. The logo is in black and white and features the company name in a bold, sans-serif font. The address "4507 Mt. Vernon St." is printed in a smaller font below the company name. 07 Mt. Vernon • Houston, Texas 77006 • (713) 526-9677 • Toll Free Number 1-800-231-6238 24 hrs. Fax No.: 713-526-1528 # 510(k) SUMMARY 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. The assigned Premarket Notification [510(k)] Number is:_______________________________________________________________________________________________________________________ | Submitter: | Ramco Laboratories, Inc.<br>4507 Mt. Vernon<br>Houston, Texas 77006 | |------------------------|-------------------------------------------------------------------------------------------------------| | Phone #:<br>Fax #: | (713) 526-9677<br>(713) 526-1528 | | Contact Person: | Jeffrey B. Grubb, President | | Dated Prepared: | September 3, 1998 | | Device Name: | von Willebrand Factor Antigen Assay | | Trade Name: | <i>VFE</i> | | Common Name: | Enzyme Assay for von Willebrand Facto <b>r</b> | | Classification Name: | Enzyme Linked Immunoassay | | Predicate Device Name: | SPECTRO vWF<br>Ramco Laboratories, Inc.<br>4507 Mt. Vernon<br>Houston, Texas 77006<br>510(k) #K861159 | {1}------------------------------------------------ #### Description of Device: VFE is an enzyme immunoassay, in microplate format, intended for the in vitro quantification of von Willebrand Factor antigen in serum or plasma as an aid to differentiate patients with von Willebrand disease from those with classical Hemophilia A. This assay represents an updated technical format, with performance improvements, when compared to the predicate device. #### Intended Use and Indications for Use: VFE is intended for use as an aid in the diagnosis and management of patients having an increased tendency to bleed. It is useful to differentiate patients with von Willebrand disease from those with Classical Hemophilia A (Factor VIII coagulant deficiency). The later group of patients have prolonged activated partial thromboplastin time (PTT) but have normal or increased concentrations of von Willebrand Factor (vWF) in their plasma. In contrast, patients with von Willebrand disease have depressed levels of vWF. VFE should be used whenever a patient demonstrates: - a decrease in procoagulant activity as measured by activated PTT; and/or i) - ii) a prolonged bleeding time. | | VFE | SPECTRO vWF | |-------------|-------------------------------------------------------------------|-------------------------------------------------| | Methodology | Sandwich ELISA | Sandwich ELISA | | Solid phase | coated microtiter<br>wells | coated beads | | Material | polystyrene | polystyrene | | Antibody | rabbit anti-human<br>vWF, IgG from<br>(NH4)2SO4 | rabbit anti-human<br>vWF, IgG from<br>(NH4)2SO4 | | Conjugate | HRP labeled anti-<br>human vWF antibody<br>Labeled anti-human vWF | Alkaline<br>phosphatase | | Antibody | sheep | rabbit | ### Summary of Technological Characteristics of Predicate and Proposed Device {2}------------------------------------------------ | Sample Material | serum, plasma in<br>EDTA or citrate | plasma in<br>EDTA or citrate | |--------------------------|-----------------------------------------------|-----------------------------------------------| | Sample dilution | 1:51 and 1:102 if<br>Needed | 1:51 | | Sample volume | 20 microliters<br>10 microliters if needed | 50 microliters; | | Incubations | 2 | 2 | | Length #1 | 2 hours, 10 min. | 2 hours | | Length #2 | 30 minutes | 30 minutes | | Washes | 4 | as needed | | Wash material | 1X diluted wash<br>Buffer | deionized water | | Calibrator | Lyophilized, pre-diluted<br>human plasma pool | liquid purified human<br>vWF in buffer | | Number | 5 dilutions per assay | one per assay | | Assay Reading | microplate reader | spectrophotometer | | Wavelength | 450 nm | 492 nm | | Background<br>correction | yes | no | | Substrate | TMB | phenylphosphate<br>disodium, 4-amino-tipyrine | | Components/kit | 1 | 2 | | Color developer | none | potassium ferricyanide | | Stop Solution | 1% HCl | none | : {3}------------------------------------------------ ## Non-clinical Performance Discussion: The following non-clinical performance data comparison indicates that SPECTRO vWF, the predicate test, and VFE have similar characteristics and are substantially equivalent. | Parameter | VFE | SPECTRO vWF | |-------------------------------------|---------------------|--------------------| | Sensitivity | 0.78% N | 0.23% N | | Intra-assay<br>reproducibility - CV | 5.0 - 5.8 | 6.2 - 8.0 | | Inter-assay<br>reproducibility - CV | 7.0 - 11.5 | 6.3 - 12.8 | | Accuracy - R | 0.849*<br>(n = 118) | 0.96**<br>(n = 24) | compared to predicate test results **original comparison versus Laurell Rocket electrophoresis results ### Conclusions from Non-clinical Testing: Based on the above results the performance characteristics of, VFE, the subject device, and SPECTRO vWF, are substantially equivalent. Since two tests have very similar technological characteristics, this conclusion is not unexpected. {4}------------------------------------------------ Image /page/4/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all caps and is evenly spaced around the caduceus symbol. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 2 2 1998 Mr. Jeffrey B. Grubb President Ramco Laboratories, Inc. 4507 Mt. Vernon Houston, Texas 77006 Re: K983107 Trade Name: VFE Regulatory Class: II Product Code: GGP Dated: September 3, 1998 Received: September 4, 1998 Dear Mr. Grubb: 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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. {5}------------------------------------------------ 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"(21 CFR 807.97). Other qeneral 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 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 {6}------------------------------------------------ # INDICATIONS FOR USE STATEMENT 510(k) Number: K983107 Device Name: VEE - The VFE assay is an in vitro enzyme immunoassay Indications for Use: for quantifying the concentration of von Willebrand Factor Antigen in human plasma to aid in differentiating patients with von Willebrand disease from those with Classical Hemophilia A. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | |--------------------------------------------------------| |--------------------------------------------------------| | | <div>(Division Sign-Off)</div> <div>Division of Clinical Laboratory Devices</div> | |---------------|-----------------------------------------------------------------------------------| | 510(k) Number | K983107 | | Prescription Use | ✓ | OR | Over-The-Counter | |------------------|---|----|------------------| |------------------|---|----|------------------|