← Product Code [LJM](/productcode/LJM) · K992041 # RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 (K992041) _Immuno Concepts, Inc. · LJM · Jul 23, 1999 · Immunology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K992041 ## Device Facts - **Applicant:** Immuno Concepts, Inc. - **Product Code:** [LJM](/productcode/LJM.md) - **Decision Date:** Jul 23, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5100 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use This is an enzyme immunoassay test system for the detection of antinuclear antibodies in human serum. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease. ## Device Story RELISA® ANA Screening Test System is an enzyme immunoassay (EIA) for detecting antinuclear antibodies (ANA) in human serum. Used in clinical laboratory settings to aid in diagnosing systemic rheumatic disease. Device utilizes microwell strips packaged in individual pouches to maintain stability. Operation involves testing patient serum samples; results are determined via calibrator serum. Output provides qualitative detection of ANA. Clinical utility lies in identifying antibodies associated with autoimmune conditions. Compared to predicate, device offers improved shelf-life stability for microwells and utilizes a calibrator serum rather than a cutoff control serum. ## Clinical Evidence Clinical performance evaluated by comparing the RELISA® ANA test against a predicate EIA method and a referee indirect fluorescent antibody (IFA) method. Initial comparison to predicate showed 85.4% agreement. Upon re-testing discordant samples using the HEp-2000® ANA-Ro IFA method, the adjusted overall agreement was 93.5% (305 true positives, 791 true negatives, 72 false positives, 4 false negatives). ## Technological Characteristics Enzyme immunoassay (EIA) test system. Components include microwell strips, reagents, and calibrator serum. Microwells are individually pouched for 12-month stability. Detection principle is based on enzyme-linked immunosorbent assay for antinuclear antibodies in human serum. ## Regulatory Identification An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues). ## Predicate Devices - Enzyme Immunoassay Antinuclear Antibody Screening Test Kit ([K954723](/device/K954723.md)) ## Reference Devices - Immuno Concepts HEp-2000® ANA-Ro Test System ([K944096](/device/K944096.md) & [K972145](/device/K972145.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}------------------------------------------------ KG92041 Image /page/0/Picture/2 description: The image shows the logo for Immuno Concepts. The logo consists of a stylized "IC" symbol followed by the word "immuno" in a bold, sans-serif font. Below "immuno" is the word "concepts" in a smaller, bold, sans-serif font. The logo is black and white. - 510(k) SUMMARY * --- Date Prepared: July 12, 1999 Contact Person: Eric S. Hoy, Ph.D., SI(ASCP) Name of Device: - · Trade Name RELISA® ANA Screening Test System - Common Name Antinuclear Antibody Enzyme Immunoassay Test System - · Classification Name Antinuclear Antibody (21 CFR 866.5100) Legally marketed device with which this device has been shown to be equivalent: Enzyme Immunoassay Antinuclear Antibody Screening Test Kit manufactured by Helix Diagnostics, West Sacramento, CA, K954723. ### Description: This is an enzyme immunoassay for the detection of antinuclear antibodies in human serum. #### Intended Use: This is an enzyme immunoassay test system for the detection of antinuclear antibodies in human serum. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease. ### Summary of Technological Characteristics Compared to the Predicate Device: Technologically, this device is similar to the predicate device with the following exceptions: The predicate device has all 96 microwells sealed in a single pouch. a) After this pouch is opened, the wells remain stable for only 30 days. 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 a cutoff control serum, the present device uses a calibrator serum in the kit. ## Description of Laboratory Data That Indicate Substantial Equivalence: For direct determination of relative sensitivity and specificity, we used the Enzyme Immunoassay Antinuclear Antibody Screening Test Kit manufactured by Helix Diagnostics, West Sacramento, CA, (K954723) as a reference method. The data obtained in this comparison are shown in the following Table. | Helix Diagnostics Enzyme Immunoassay Antinuclear
Antibody Screening Test | | Positive | Negative | |-----------------------------------------------------------------------------|------------|----------|----------| | Immuno Concepts
RELISA® Antinuclear
Antibody Test | Positive | 214 | 46 | | | Borderline | 12 | 105 | | | Negative | 8 | 787 | Borderline results were considered positive. These data show an overall agreement of 85.4% {1}------------------------------------------------ The large number of "false positive" samples seen with the Immuno Concepts test was troubling, so we tested all of these sera for antinuclear antibodies using Immuno Concepts HEp-2000® ANA-Ro Test System (K944096 & K972145). Seventy-nine of the "false positive" samples were shown to have clearly discernible ANA patterns with the indirect fluorescent antibody technique and were considered "true positives" for the detection of antinuclear antibodies. Four of the "false negative" samples were shown to be negative by the indirect fluorescent antibody technique and were considered "true negatives" for the detection of antinuclear antibodies. Thus, when the referee method is taken into account, the comparison looks like this: | | | Reference
Positive | Method
Negative | |---------------------------------------------------------|----------|-----------------------|--------------------| | Immuno Concepts
RELISA° Antinuclear
Antibody Test | Positive | 305 | 72 | | | Negative | 4 | 791 | These data show an overall agreement of 93.5% 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}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble waves or fabric. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUL 23 1999 Eric S. Hoy, Ph.D., SI (ASCP) Chief Scientific Officer Regulatory Affairs Immuno Concepts, N.A., Limited 2280 Springlake Road, Suite 106 Dallas, Texas 75234 Re: K992041 > Trade Name: RELISA® ANA Screening Test System Regulatory Class: II Product Code: LJM Dated: June 15, 1999 Received: June 17, 1999 Dear Dr. Hoy: 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 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours. Steven Sutman 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}------------------------------------------------ # K992041 510(k) number (if known): Device Name: RELISA® ANA Screening Test System Indications for use: . . This is an enzyme immunoassay test system for the detection of antinuclear antibodies in human serum. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR イン Peter E. Machon vision Sign-Off) of Clinical Laboratory Devices Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda-staging.innolitics.com/device/K992041](https://fda-staging.innolitics.com/device/K992041) **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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