← Product Code [DAE](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAE) · K992488 # TOTAL HAEMOLYTIC COMPLEMENT RID KIT (K992488) _The Binding Site, Ltd. · DAE · Sep 17, 1999 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAE/K992488 ## Device Facts - **Applicant:** The Binding Site, Ltd. - **Product Code:** [DAE](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAE.md) - **Decision Date:** Sep 17, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5240 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use For measuring human haemolytic complement activity in human serum, as an aid in the assessment of complement activity by the Classical pathway in clinical laboratories, and as an aid in the diagnosis of complement component deficiencies. ## Device Story The Total Haemolytic Complement RID Kit is an in vitro diagnostic device used in clinical laboratories to measure complement activity in human serum. It utilizes Radial Immunodiffusion (RID) technology to quantify complement function via the Classical pathway. The device assists clinicians in assessing immune system function and diagnosing complement component deficiencies. Results are interpreted by laboratory professionals to inform clinical decision-making regarding patient immune status. ## Technological Characteristics Radial Immunodiffusion (RID) assay for the measurement of complement activity in human serum. In vitro diagnostic device. ## Regulatory Identification A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. ## 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 ## SEP 1 7 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 The Binding Site, Limited C/O Mr. Jay H. Geller East Tower, Suite 600 2425 West Olympic Boulevard Santa Monica, California 90404 Re: K992488 > Trade Name: Total Haemolytic Complement RID Kit Regulatory Class: II Product Code: DAE Dated: July 21, 1999 Received: July 26, 1999 Dear Mr. Geller: 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. {1}------------------------------------------------ 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 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 {2}------------------------------------------------ Total Haemolytic Complement Kit Device Name: For measuring human haemolytic complement Indications for Use: Indications for ose. Tor meabway in human serum, as an aid in activity by the Crassical pachar in Maxical Bank, and and with complement component deficiencies. Peter E. Maksimi Division Sign-Off Prescription - 1999 1995 - 1 --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAE/K992488](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAE/K992488) **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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