← Product Code [KTN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN) · K963425 # GENZYME DIAGNOSTICS CONTRAST MONO (K963425) _Genzyme Diagnostics · KTN · Feb 25, 1997 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN/K963425 ## Device Facts - **Applicant:** Genzyme Diagnostics - **Product Code:** [KTN](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN.md) - **Decision Date:** Feb 25, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5640 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician’s office laboratory and the clinical laboratory. ## Device Story Rapid membrane-based immunoassay for qualitative detection of human IgM antibodies to heterophile antigen. Input: serum, plasma, or whole blood samples. Principle: utilizes mouse monoclonal anti-IgM antibodies and heterophile antigen derived from bovine red blood cells. Output: visual qualitative result (positive/negative). Used in physician office laboratories and clinical laboratories by professional staff. Assists clinicians in diagnosing acute infectious mononucleosis. ## Clinical Evidence Multicenter study across three physician office laboratories and one clinical laboratory. Total of 480 specimens (serum, plasma, whole blood) tested. Comparison against Quidel Concise® Plus™ Mono showed 99.2% agreement (476/480). Reproducibility panel tested in replicates of 5 over three days demonstrated consistent results. ## Technological Characteristics Membrane-based immunoassay. Reagents: mouse monoclonal anti-IgM antibodies, bovine red blood cell-derived heterophile antigen. Form factor: rapid test kit. No electronic components or software. ## Regulatory Identification An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis. ## Predicate Devices - Quidel CONCISE® PLUS™ MONO ## 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} K963425 FEB 25 1997 510(k) Notification Genzyme Diagnostics Contrast® Mono August 30, 1996 # 510(k) Summary of Safety and Effectiveness ## Information Upon Which An Equivalence Determination Could Be Made | Trade or Proprietary Name: | Contrast® Mono Test | | --- | --- | | Common or Usual Name: | Infectious Mononucleosis Test for Human IgM antibodies to Heterophile Antigen | | Product Classification Number: | 21 CFR § 866.5640, Class II *Handwritten signature* | | Manufacturer: | Genzyme Diagnostics 1531 Industrial Road San Carlos, CA 94070 | | Contact Person: | Delia R. Bethell, Ph.D. Director of Research and Development Phone: (415) 594-0513 Fax: (415) 594-0571 | | Predicate Device: | Quidel CONCISE® PLUS™ MONO | | Device Description: | Rapid membrane based immunoassay for the qualitative detection of human IgM antibodies to heterophile antigen using mouse monoclonal anti-IgM antibodies and heterophile antigen from bovine red blood cells. | | Intended Use: | The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician’s office laboratory and the clinical laboratory. | A multicenter clinical study was performed in three physician’s office laboratories, POL, (including two university student health clinics) and one clinical laboratory. The Genzyme Diagnostics Infectious Mono Test was provided to the sites. Each site also used the legally marketed Quidel Concise® Plus™ Mono Test. The Quidel test is marketed for laboratory and professional use. The clinical laboratory performed the Genzyme and Quidel tests on serum and plasma specimens submitted for infectious mononucleosis. The university student health centers tested whole blood and plasma from students presenting with symptoms consistent with a diagnosis of infectious mononucleosis. A total of 480 serum, plasma and whole blood specimens were tested and compared with the reference method. Page 9 of 87 {1} 510(k) Notification Genzyme Diagnostics Contrast® Mono August 30, 1996 The results demonstrate that the Genzyme Diagnostic Infectious Mono Test has a 99.2% agreement with the Quidel Concise® Plus™ Mono (476/480). There was no difference in performance between the university student health centers and the clinical laboratory. Contrast® Mono | | Positive | Negative | | --- | --- | --- | | Positive | 58 | 3 | Concise® Plus™ Mono | Negative | 1 | 418 | | --- | --- | --- | Individuals with various levels of training tested a blind reproducibility panel using the Genzyme Diagnostics Contrast® Mono Test. Panel samples in replicates of 5 were tested on three different days. The Contrast® Mono Test demonstrated reproducible results at three physician's office laboratories. These results establish that the Genzyme Diagnostic Contrast® Mono Test is substantially equivalent to Quidel Concise® Plus™ Mono Test. The Contrast® Mono Test can detect human IgM antibodies to heterophile antigen in serum, plasma, and whole blood samples. The intended use of the Genzyme Diagnostic Contrast® Mono Test is for the detection of human IgM antibodies to heterophile antigen as an aid in the diagnosis of acute infectious mononucleosis. This product will be marketed for laboratory and professional use. Page 10 of 87 --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN/K963425](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTN/K963425) **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