← Product Code [MID](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MID) · K060176 # EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (K060176) _Theratest Laboratories, Inc. · MID · Feb 7, 2006 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MID/K060176 ## Device Facts - **Applicant:** Theratest Laboratories, Inc. - **Product Code:** [MID](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MID.md) - **Decision Date:** Feb 7, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.5660 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Intended Use The TheraTest EL-aCL™screen and TheraTest EL-aCL™ IgM, InG, IgA are intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against the phospholipid cardiolipin. ## Device Story TheraTest EL-aCL™ Screen and TheraTest EL-aCL™ IgM, IgG, IgA are in vitro diagnostic immunoassays. Device utilizes human serum samples to detect and quantify autoantibodies directed against cardiolipin. Intended for use in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in the diagnosis and management of patients with suspected autoimmune conditions associated with anti-phospholipid antibodies. Device provides quantitative or qualitative measurement of specific antibody classes (IgM, IgG, IgA) or a screening result, aiding in clinical decision-making regarding autoimmune disease status. ## Clinical Evidence No clinical data provided in the document; bench testing only. ## Technological Characteristics In vitro diagnostic immunological test system. Principle of operation involves detection of autoantibodies against cardiolipin in human serum. Class II device (Product Code: MID). ## 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). ## 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}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Public Health Service FEB 7 2006 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Theratest Laboratories, Inc. c/o Marius Teodorescu, M.D., Ph.D. President and CEO 1111 N. Main St. Lombard, IL 60148 Re: k060176 Trade/Device Name: TheraTest EL-aCL™ Screen and TheraTest EL-aCL™ IgM, IgG, IgA Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies, immunological test system Regulatory Class: Class II Product Code: MID Dated: January 17, 2006 Received: January 23, 2006 Dear Dr. Teodorescu: 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. {1}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will anow you to ought anding of substantial equivalence of your device to a legally premarked notification: "The PDF maning sification 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), please IT you desire specific at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Robert H. Becker Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known):_k060176 Device Name: TheraTest EL-aCL™ screen and TheraTest EL-aCL™ IgM, IgG, IgA Indications For Use: "The TheraTest EL-aCL™screen and TheraTest EL-aCL™ IgM, InG, IgA are intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against the phospholipid cardiolipin. Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Mana chon Division Sign-Off Office of In Vitro Diagnost Device Evaluation and Safety 510(k) Ko60176 --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MID/K060176](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MID/K060176) **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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