← Product Code [MOB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB) · K013285 # RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 (K013285) _Immuno Concepts, Inc. · MOB · Nov 14, 2001 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB/K013285 ## Device Facts - **Applicant:** Immuno Concepts, Inc. - **Product Code:** [MOB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB.md) - **Decision Date:** Nov 14, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5660 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use This is an enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum. This test system is to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides. ## Device Story Enzyme immunoassay (EIA) test system for detection of anti-myeloperoxidase (MPO) antibodies in human serum; used in clinical laboratory settings. Device utilizes microwell strips to capture antibodies; results interpreted by healthcare providers to aid in diagnosis of vasculitides including microscopic polyangiitis and glomerulonephritis. Subject device features individual pouch packaging for 8-well strips to improve stability and uses five calibrator sera compared to six in the predicate. Output provides qualitative or semi-quantitative detection of MPO antibodies, assisting clinicians in differential diagnosis of autoimmune vasculitis. ## Clinical Evidence Clinical study compared subject device to predicate using 758 human serum samples (including patients with Churg-Strauss, vasculitis, Wegener's granulomatosis, and healthy donors). Results: 96.4% relative sensitivity, 94.6% relative specificity, and 94.7% overall agreement. 38 false positives were noted, with 28 showing P-ANCA patterns by immunofluorescence. ## Technological Characteristics Enzyme immunoassay (EIA) test system. Microwell plate format. Features individual foil pouch packaging for 8-well strips to maintain stability. Uses five calibrator sera. Class II device (21 CFR 866.5660). ## Regulatory Identification A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies). ## Predicate Devices - Bindazyme™ Anti-MPO Enzyme Immunoassay Kit ([K981030](/device/K981030.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Immuno Concepts. The logo is black and white and features a stylized "IC" with the words "Immuno" and "Concepts" stacked on top of each other. The "I" in "IC" is represented by two horizontal lines, and the "C" is represented by a circle with three smaller circles inside. NOV 1 4 2001 Date Prepared: July 23, 2001 Contact Person: Eric S. Hoy, Ph.D., SI(ASCP) Name of Device: - · Trade Name RELISA® MPO-ANCA Test System for Antibodies to Myeloperoxidase - · Common Name Anti-MPO Antibody Enzyme Immunoassay Test Kit - · Classification Name · Test System, Antineutrophil Cytoplasmic Antibodies (ANCA) (21 CFR 866.5660) Legally marketed device with which this device has been shown to be equivalent: Bindazyme™ Anti-MPO Enzyme Immunoassay Kit manufactured by The Binding Site, Ltd., Birmingham, England, UK, K981030. ### Description: This is an enzyme immunoassay for the detection of antibodies to myeloperoxidase (MPO) in human serum. ### Intended Use: This is an enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum. This test system is to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides. ### Summary of Technological Characteristics Compared to the Predicate Device: Technologically, this device is similar to the predicate device with the following exceptions: a) The predicate device has all 96 microwells sealed in a single pouch. The present device has each eight well strip of microwells sealed in an individual pouch, so that unused wells remain in the pouches, and maintain at least 12 months stability. b) The predicate device uses six calibrator sera, the present device uses five calibrator sera. ### Description of Laboratory Data That Indicate Substantial Equivalence: The Immuno Concepts RELISA® MPO Test System was compared to the Bindazyme™ Anti-MPO Enzyme Immunoassay Kit manufactured by The Binding Site, Ltd., Birmingham, England, UK. (K981030). The population studied consisted of 208 samples which were submitted to clinical laboratories for ANCA, MPO and PR3 testing, but without specific diagnoses, 7 samples which were from pateints with a diagnosis of Churg-Strauss syndrome, 18 patients with a diagnosis of vasculitis, 25 patients with a diagnosis of Wegener's granulomatosis, 261 All samples from male blood donors, and 239 samples from female blood donors. samples were tested in parallel on the predicate device and the subject device. Based on this comparison, the following data were obtained: {1}------------------------------------------------ ### Bindazyme™ Antl-MPO Enzyme lmmunoassay Kit Negative Positive | Immuno Concepts | Positive | 53 | 38 | |---------------------------------|----------|----|-----| | RELISA® MPO-ANCA
Test System | Negative | 2 | 665 | These data yield the following statistics: relative sensitivity, 96.4%; relative specificity, 94.6%; and overall agreement, 94.7% Among the 38 "false positive" samples, 28 showed a P-ANCA pattern by Among the 56 Traise postere banged, by immunofluorescence, 3 showed immanoridorescence, 3 Biowed a Chilon parceace, and 4 did not demonstrate any immunofluorescent pattern. In accordance with 21 CFR 807.92(b)(3), we conclude from these data that the present device is substantially equivalent to the predicate device. {2}------------------------------------------------ Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Eric Hoy, Ph.D., SI (ASCP) NOV 1 4 2001 Chief Scientific Officer, Regulatory Affairs Immuno Concepts, Inc. 2280 Springlake Road, Suite 106 Dallas, Texas 75234 Re: K013285 Trade/Device Name: Immuno Concepts RELISA® MPO-ANCA Test System for Antibodies to Myeloperoxidase Regulation Number: 21 CFR § 866.5660 Regulation Name: ANCA Test System Regulatory Class: II Product Code: MOB Dated: September 27, 2001 Received: October 2, 2001 Dear Dr. Hoy: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {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 International and Consumer 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 Autman 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}------------------------------------------------ NOV 1 4 2001 Page 1 of 1 510(k) number (if known): Device Name: RELISA® MPO-ANCA Test System for Antibodies to Myeloperoxidase # Indications for use: This is an enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum. This test system is to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides. Sousan Saltaie 510(k) Numb # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use J (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB/K013285](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MOB/K013285) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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