PR 3 ANTIBODY KIT

{0}------------------------------------------------ # K973823 ## 510(k) Summary NOV 1 3 1997 #### Submitter's Name/Contact Person 1. Joseph M. Califano Manager, Regulatory Affairs ### Address Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, MA, 02154 (617) 890-3766 Phone: (617) 890-3748 Fax: jcalifano@hemagen.com email: ## Date Prepared 26 September 1997 #### Device Name 2. | Trade Name: | VIRGO® cANCA Kit (EIA method) | |----------------------|---------------------------------------------------| | Common Name: | PR3 Antibody Kit | | Classification Name: | Antineutrophil Cytoplasmic Antibodies test system | #### Predicate Device 3. Scimedx EIA Kit For the Detection of Anti-PR3 Antibodies Scimedx Election AN - 16 051105) {510 (k) Docket No. K 954105} {1}------------------------------------------------ #### Description of Device 3. An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of autoantibodies to the antigen Proteinase 3 in human serum. The ELISA methodology is commonly used for serum antibody evaluations. Purified PR3 antigen has been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigen and remain in place after a wash step. A second antibody which is conjugated 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) designed for the detection and measurement of autoantibodies to the antigen Proteinase 3 in human serum. The test is intended as an aid in the diagnosis of current or past autoimmune mediated vasculitides. ### 5.(A) Technological Characteristics ### Proposed Device The VIRGO ® cANCA 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 Device The Scimedx ANTI-PR3 ANTIBODY EIA is also 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. {2}------------------------------------------------ ## 5.(B) Performance Data ### Precision To evaluate precision, both inter-assay and intra-assay studies were conducted. The results are summarized below: Eight serum samples were assayed in duplicate twice a day for five different days. | Sample | Mean OD | Std. Dev. | % CV | Mean Units | Std. Dev | % CV | |--------|---------|-----------|------|------------|----------|------| | 1 | 1.444 | 0.112 | 7.8 | 7.3 | 0.6 | 7.9 | | 2 | 1.060 | 0.070 | 6.6 | 5.3 | 0.4 | 8.0 | | 3 | 0.128 | 0.020 | N/A | 0.6 | 0.1 | N/A | | 4 | 0.037 | 0.009 | N/A | 0.2 | 0.04 | N/A | | 5 | 0.770 | 0.075 | 9.7 | 3.7 | 0.5 | 12.3 | | 6 | 0.586 | 0.059 | 10.1 | 3.0 | 0.3 | 11.1 | | 7 | 0.515 | 0.039 | 7.5 | 2.6 | 0.2 | 8.2 | | 8 | 0.351 | 0.040 | 11.5 | 1.8 | 0.2 | 11.7 | 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 | 0.011 | 0.004 | N/A | | Positive Control | 0.863 | 0.068 | 7.8 | | Cutoff Serum | 0.197 | 0.012 | 6.2 | ### B. Intra-assay Eight serum samples were assayed 20 consecutive times in a single run. | Sample | Mean OD | Std. Dev. | % CV | Mean Units | Std. Dev. | % CV | |--------|---------|-----------|------|------------|-----------|------| | 1 | 1.197 | 0.073 | 6.1 | 6.1 | 0.4 | 6.7 | | 2 | 0.818 | 0.045 | 5.6 | 4.1 | 0.2 | 5.7 | | 3 | 0.131 | 0.005 | 3.7 | 0.7 | 0.02 | 3.7 | | 4 | 0.057 | 0.003 | 4.4 | 0.3 | 0.01 | 4.4 | | 5 | 0.563 | 0.034 | 6.1 | 3.0 | 0.2 | 6.4 | | 6 | 0.460 | 0.032 | 6.9 | 2.4 | 0.1 | 6.1 | | 7 | 0.407 | 0.020 | 4.9 | 2.2 | 0.1 | 4.9 | | 8 | 0.269 | 0.018 | 6.8 | 1.5 | 0.1 | 6.7 | {3}------------------------------------------------ Comparison Testing A total of 108 serum specimens (28 from individuals with Wegners Granulomatosis, and 80 includes that follow: Computers. A total of 108 serum specimens (28 from individuals with Wegners). from normal apparently donors) were concurrently assayed by both the predice. A total of 108 serum specifieds (2011-11-11). from normal apparently healthy donors) were concurrently assayed by bom the posses from normal apparently healthy donors) were p | Table 1.1 Panel 1, n = 28 { Positive Panel} | Predicate Device | |---------------------------------------------|------------------| |---------------------------------------------|------------------| | | Positive | Negative | l olai | |--------------------------------------------------------------------------------------------|----------|------------------|--------------------------------------------| | Proposed Device<br>Positive | 28<br>O | 0<br>O | 28<br>O | | Negative | 28 | O | 28 | | Relative Sensitivity = 100.0 % {28/28}, oss confidence interval = 87.9 % to 100 % = 100.0 | | | | | | | | | | Table 1.2 Normals, n = 80 | | Predicate Device | | | | Positive | Negative | Total | | Proposed Device<br>Positive | 0<br>0 | 0<br>80 | 0<br>80 | | Negative | 0 | 80 | 80 | | Total | . | | --- confidence interval = 95.4 % to 100 % | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Realive open and and with the assay following the assay following NCCLS ------------------------------------------------------------------------------------------------------Interiog Substances Interfering Substances were versions the evention in Clinical Chemistry. The Subscription of the Subscription of the Subscription of the Subscription of t more of Gric, and hemolyte samples were Testing in Chincal Onemical onemical of the more Liberine, icter7-P Proposed Guideline, interence Testing in the assay for samples res with: Hemoglobin concentration: Hemoglobili concentration: Lipid concentration: < 500 mg/dL < 20 mg/dL < 3000 mg/dL Prozone The VIRGO® © eANCA Kit was used to assay several high titered serum samples to doch if the ViRGO ® cANCA Kit was used to assay several high titered sera. The VIRGO ® CANOT Production of the results with high titered sera. if the kit would return unexpectedly low values with high titered sera. kit gives appropriately high posit ## Conclusions Conclusions The results of the comparative studies support the claim that the proposed device is Ochender {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 NOV 1 3 1997 Mr. Joseph M. Califano Manager, Regulatory Affairs Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, Massachusetts 02154 Re : K973823 Trade Name: VIRGO® cANCA Kit (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, 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, labelinq, 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 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 requlatory 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}------------------------------------------------ Paqe 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.qov/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 Radioloqical Health Enclosure {6}------------------------------------------------ K9738223 Device Name: VIRGO ® cANCA Kit Indication(s) For Use This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection of autoantibodies to the antigen Proteinase 3 in human serum. The presence of PR-3 antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of Wegener's granulomatosis (WG) and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA) #### (PLEASE DO NOT WRITE BELOW THIS LINE) Concurrence of CDRH, Office of Device Evaluation (ODE) Peter E. Madem (Division Sign-Off) Division of Clinical Laboratory Dev 510(k) Number _ Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use