← Product Code [MSV](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MSV) · K022945 # AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA (K022945) _Hycor Biomedical, Inc. · MSV · Dec 18, 2002 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MSV/K022945 ## Device Facts - **Applicant:** Hycor Biomedical, Inc. - **Product Code:** [MSV](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MSV.md) - **Decision Date:** Dec 18, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5660 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Intended Use Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to ß2-Glycoprotein I (ß2-GPI) antibodies in human serum. Uses: The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-B-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. This device can be used with the HYCOR HY•TEC automated EIA instrument. For in vitro diagnostic use only. ## Device Story Autostat™ I Anti-ß2 Glycoprotein-IgG ELISA is an enzyme-linked immunosorbent assay for detecting specific IgG autoantibodies in human serum. Device functions as an aid in diagnosing autoimmune conditions like antiphospholipid syndrome. Designed for use with the HYCOR HY•TEC automated EIA instrument. Clinical laboratory personnel perform the assay; results provide semi-quantitative data used by physicians as one component of a multi-factorial diagnostic regime. ## Clinical Evidence No clinical data provided in the document; substantial equivalence determination based on bench-level performance characteristics for an ELISA-based immunological test system. ## Technological Characteristics Enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgG autoantibodies. Designed for compatibility with the HYCOR HY•TEC automated EIA instrument. In vitro diagnostic device. ## 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 consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Food and Drug Administratio 098 Gaither Road ockville MD 20850 DEC 1 8 2002 Ms. Danielle M. Knight Quality Manager Hycor Biomedical Ltd. Pentlands Science Park Bush Laon, Penicuik Midothian EH26 OPL Scotland, UK Re: k022945 Trade/Device Name: Autostat™I Anti-ß2 Glycoprotein -IgG ELISA Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MSV Dated: December 5, 2002 Received: December 9, 2002 Dear Ms. Knight: 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {1}------------------------------------------------ ## Page 2 This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Putman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use. Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to ß2-Glycoprotein I (ß2-GPI) antibodies in human serum. Uses: The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-B-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. This device can be used with the HYCOR HY•TEC automated EIA instrument. For in vitro diagnostic use only. for Prescription ✓ J. Alves for J. Batista (Division Sign-Off) Division of Clinical Laboratory Devices 022945 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MSV/K022945](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MSV/K022945) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com