VIRGO ANCA SCREEN KIT

{0}------------------------------------------------ # K973822 # 510(k) Summary - Submitter's Name/Contact Person 1. Joseph M. Califano Manager, Regulatory Affairs # Address Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, MA, 02154 | Phone: | (781) 890-3766 | |--------|-----------------------| | Fax: | (781) 890-3748 | | email: | jcalifano@hemagen.com | ### Date Prepared 30 September 1997 #### 2. Device Name | Trade Name: | VIRGO® ANCA SCREEN (EIA method) | |----------------------|---------------------------------------------------| | Common Name: | PR3 and MPO Antibody Kit | | Classification Name: | Antineutrophil Cytoplasmic Antibodies test system | #### 3. Predicate Devices - Scimedx EIA Kit For the Detection of Anti-PR3 Antibodies a. {510 (k) Docket No. K 954105} - Scimedx EIA Kit For the Detection of Anti-MPO Antibodies b. {510 (k) Docket No. K 954062} NOV 1 3 1997 {1}------------------------------------------------ #### Description of Device 3. An enzyme-linked immunosorbent assay (ELISA) designed for the detection of autoantibodies to the antigens Proteinase 3 and mveloperoxidase in human serum. The ELISA methodology is commonly used for serum antibody evaluations. Purified PR3 and Myeloperoxidase antigens have been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigens and remain in place after a wash step. A second antibody which is conjucated to horseradish peroxidase (HRP) is used to recognize the "heavy + light" chain regions of the patient's antibodies remaining after the wash step. In the wells where the second antibody remains bound, the conjugated HRP catalyzes a color change in the substrate, tetramethyl benzidine (TMB). After the reaction is stopped, the color is read in an EIA Plate reader. ### 4. Intended Use of Device An enzvme-linked immunosorbent assay (ELISA) intended to determine an individual's serologic status with respect to autoantibodies to the antigens Proteinase 3 and myeloperoxidase in human serum. ### 5.(A) Technological Characteristics ### Proposed Device The VIRGO ® ANCA SCREEN Kit is an enzyme-linked immunosorbent assay. The device utilizes optical density as a measure of antibody presence, with an established cutoff between a positive and a negative reaction. #### Predicate Devices The Scimedx ANTI-PR3 ANTIBODY EIA and the Scimedx ANTI-MPO ANTIBODY EIA are also an enzyme-linked immunosorbent assays. Both of the devices utilize optical density as a measure of antibody presence, with an established cutoff between a positive and a negative reaction. {2}------------------------------------------------ # 5.(B) Performance Data ### Precision To evaluate precision, both inter-assay and intra-assay studies were conducted. The results are summarized below: #### A. Inter-assay Eight samples were assayed twice a day for five different days. | Sample | Mean OD | Std. Dev. | % CV | |--------|---------|-----------|------| | 1 | 1.622 | 0.151 | 9.3 | | 2 | 0.731 | 0.093 | 12.7 | | 3 | 0.532 | 0.057 | 10.7 | | 4 | 0.787 | 0.096 | 12.2 | | 5 | 0.777 | 0.093 | 12.0 | | 6 | 1.375 | 0.152 | 11.1 | | 7 | 0.071 | 0.007 | N/A | | 8 | 0.040 | 0.007 | N/A | The assay controls {Positive, Negative, and Cutoff Serum} were assayed concurrently twice a day for each of the five days. | Sample | Mean OD | Std. Dev. | % CV | |------------------------|---------|-----------|------| | Negative Control | 0.009 | 0.003 | N/A | | cANCA Positive Control | 1.538 | 0.115 | 7.5 | | pANCA Positive Control | 0.973 | 0.145 | 14.9 | | Cutoff Serum | 0.224 | 0.019 | 8.5 | #### B. Intra-assay The eight serum samples were assayed 20 consecutive times in a single run. | Sample | Mean OD | Std. Dev. | % CV | |--------|---------|-----------|------| | 1 | 1.563 | 0.072 | 4.6 | | 2 | 0.763 | 0.072 | 9.4 | | 3 | 0.557 | 0.052 | 9.3 | | 4 | 0.916 | 0.103 | 11.2 | | 5 | 0.777 | 0.057 | 7.3 | | 6 | 1.233 | 0.173 | 14.0 | | 7 | 0.083 | 0.006 | 7.2 | | 8 | 0.046 | 0.003 | 6.5 | {3}------------------------------------------------ #### Comparison Testing A total of 109 serum specimens (17 from individuals with Wegners Granulomatosis, 19 pANCA A would or 100 bornh op of our the United States, and 73 from normal apparently positive specificals taken from ally assayed by both the predicate device and the proposed device. The results are summarized in the tables that follow: | Table 1.1 Positive Panels, n = 36} | | | | |------------------------------------|------------------|----------|-------| | | Predicate Device | | | | | Positive | Negative | Total | | Proposed Device | | | | | Positive | 35 | 0 | 35 | | Negative | 0 | 1 | 1 | | Total | 35 | 1 | 36 | Relative Sensitivity = 100.0 % {35/35}, "gs confidence interval = 90.1 % to 100 % | Table 1.2 Normals, n = 73 | | | | |---------------------------|----------|----------|-------| | Predicate Device | | | | | Proposed Device | Positive | Negative | Total | | Positive | 1 | 0 | 1 | | Negative | 61 | 66 | 72 | | Total | 7 | 66 | 73 | Relative Specificity = 100.0 % {66/66}, o.ss confidence interval = 94.5 % to 100 % 1. The six discrepants were evaluated by a third party IFA assay. All six of the samples were reported to be negative. {4}------------------------------------------------ #### Interfering Substances Lipemic, icteric, and hemolytic samples were evaluated with the assay following NCCLS Document EP7-P Proposed Guideline, Interference Testing in Clinical Chemistry. The results indicate that there is no significant effect (<15 % variation) on the assay for samples with: | Hemoglobin concentration: | ≤ 500 mg/dL | |---------------------------|--------------| | Bilirubin concentration: | ≤ 20 mg/dL | | Lipid concentration: | ≤ 3000 mg/dL | #### Prozone The VIRGO ® ANCA SCREEN Kit was used to assay several high titered serum samples to determine if the kit would return unexpectedly low values. The results of this evaluation indicate that the kit gives appropriately high positive results with high titered sera. #### Conclusions The results of the comparative studies support the claim that the proposed device is substantially equivalent to the predicate devices and performs as an effective screening assay. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line and are easily readable. Image /page/5/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a vector graphic. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 NOV 1 3 1997 Mr. Joseph M. Califano Manager, Regulatory Affairs Hemagen Diaqnostics, Inc. 34-40 Bear Hill Road Waltham, Massachusetts 02154 Re : K973822 Trade Name: VIRGO® ANCA Screen (EIA method) Regulatory Class: II Tier: II Product Code: мов Dated: September 30, 1997 Received: October 7, 1997 Dear Mr. Califano: 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, Druq, 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 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 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 obliqation 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. {6}------------------------------------------------ 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 requlation 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 {7}------------------------------------------------ Device Name: VIRGO ® ANCA SCREEN Kit Indication(s) For Use This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection of autoantibodies to the antigens Proteinase 3 (PR-3) and myeloperoxidase (MPA) in human serum. The presence of these antibodies, In combination with clinical observations and other serological tests, can aid in the diagnosis of Wegener's granulomatosis (WG), polyarteritis, necrotizing glomerulonephritis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA). Since a positive test result with this assay does not indicate which ANCA is (are) present, all positives should be confirmed using assays designed for particular ANCA specificities. (PLEASE DO NOT WRITE BELOW THIS LINE) Concurrence of CDRH, Office of Device Evaluation (ODE) Greta E. Malm (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number - ﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍ Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________