← Product Code [DBI](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI) · K962198 # QUANTEX C4 (K962198) _Instrumentation Laboratory CO · DBI · Sep 26, 1996 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K962198 ## Device Facts - **Applicant:** Instrumentation Laboratory CO - **Product Code:** [DBI](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI.md) - **Decision Date:** Sep 26, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5240 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use This product permits the quantitative in vitro diagnostic determination of Complement 4 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C4 is one of a group of serum proteins which destroy infectious agents. Measurement of this protein aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of C4. ## Device Story Turbidimetric immunoassay for quantitative C4 determination in serum/plasma; performed on ILab Clinical Chemistry System. Input: patient serum/plasma samples. Principle: antigen-antibody reaction causing turbidity proportional to C4 concentration. Output: quantitative C4 levels. Used in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in diagnosing immunologic disorders and C4 deficiencies. ## Clinical Evidence Method comparison study; 38 serum samples; compared quantex C4 on ILab system vs. IL Test™ C4 on Monarch system. Correlation coefficient (r) = 0.9791. ## Technological Characteristics Turbidimetric immunoassay; reagents include anti-human C4 and buffer. Designed for use on ILab Clinical Chemistry System. Quantitative measurement of serum proteins. ## 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. ## Predicate Devices - IL Test™ C4 ([K920010](/device/K920010.md)/B) ## 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} # SECTION 3 ## quantex C4 - 510(k) SUMMARY ### (Summary of Safety and Effectiveness) **Submitted by:** Betty Lane Director, Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 phone (617) 861-4182 fax (617) 861-4464 *K962198* **SEP 26 1996** **Contact Person:** Betty Lane phone (617) 861-4182 **Summary Prepared:** May 29, 1996 **Name of the device:** quantex C4: 8 x 6 mL anti-human C4 P/N 3000-22137 2 x 100 mL Buffer P/N 3000-22130 **Classification name(s):** 866.5240 Complement components immunological test systems Class II **Identification of predicate device(s):** IL Test™ C4 #K920010/B **Description of the device/intended use(s):** This product permits the quantitative *in vitro* diagnostic determination of Complement 4 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C4 is one of a group of serum proteins which destroy infectious agents. Measurement of this protein aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of C4. **Statement of how the Technological Characteristics of the Device compare to the Predicate device:** Biokit’s quantex C4 is substantially equivalent in performance, intended use, safety and effectiveness to the predicate, IL Test™ C4 -- 510(k) #K920010/B. **Summary of Performance Data:** A comparative performance study was performed with IL Test™ C4 on a Monarch Clinical Chemistry System and Biokit’s quantex C4 on an ILab Clinical Chemistry System. Method comparison studies evaluated C4 levels of thirty-eight serum samples on the respective instruments. The correlation $(r)$ in these studies was 0.9791. Section 3 quantex C4 510(k) Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K962198](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBI/K962198) **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