← Product Code [LFZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/LFZ) · K954301 # ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) (K954301) _Abbott Laboratories · LFZ · Mar 24, 1997 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFZ/K954301 ## Device Facts - **Applicant:** Abbott Laboratories - **Product Code:** [LFZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/LFZ.md) - **Decision Date:** Mar 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3175 - **Device Class:** Class 2 - **Review Panel:** Microbiology - **Attributes:** Pediatric ## Intended Use The Abbott CMV Total AB Diagnostic EIA is an enzyme immunoassay for the qualitative detection of total antibody to cytomegalovirus (CMV) in human serum. It is intended to be used as an aid in the determination of serologic status to CMV. ## Device Story In vitro enzyme immunoassay (EIA) for detection of total anti-CMV antibodies in human serum; utilizes complex formation between CMV antigens and patient antibodies. Device requires spectrophotometer for objective absorbance measurement; replaces subjective erythrocyte settling pattern interpretation used in traditional IHA methods. Used in clinical laboratory settings by trained technicians to determine patient serologic status. Output provides objective absorbance values interpreted as positive or negative for CMV antibodies, aiding clinical assessment of CMV infection status. ## Clinical Evidence Multi-center study (5 facilities) evaluated 2312 specimens from healthy adults. Comparison against IHA showed 95.50% overall agreement (2186/2289). Relative sensitivity 97.17% (95% CI: 96.03-98.06%); relative specificity 93.87% (95% CI: 92.34-95.18%). Additional testing of 11 serum specimens from CMV-infected pediatric patients yielded 100% positive results. ## Technological Characteristics Enzyme immunoassay (EIA) platform; utilizes antigen-antibody complex formation; requires spectrophotometer for objective absorbance measurement. In vitro diagnostic test system. ## Regulatory Identification Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome. ## Predicate Devices - CETUS Cytomegalovirus Indirect Hemagglutination Assay (IHA) ## 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} K954301 MAR 24 1997 510(K) SUMMARY Abbott CMV Total AB Diagnostic EIA ## I. SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A SUBSTANTIALLY EQUIVALENT DETERMINATION The Abbott CMV Total AB Diagnostic EIA enzyme immunoassay is substantially equivalent to the CETUS Cytomegalovirus Indirect Hemagglutination Assay (IHA) which is based on the IHA of Yeager, and originally used for CMV antibody detection by Bernstein and Stewart prior to May 28, 1976. The Abbott CMV Total AB Diagnostic EIA and the CETUS CMV IHA are substantially equivalent in that: a. Both are intended for use in the detection of antibody to CMV. b. Both are in vitro immunological test systems. c. Both are used to determine serologic status on a single specimen. d. Both are based on the formation of complexes between CMV antigens and CMV antibody. The assays differ in that: The Abbott CMV Total AB Diagnostic EIA is designed to be used with a spectrophotometer to give an absorbance value which is interpreted objectively. The IHA result, on the other hand, is determined by a subjective interpretation of the erythrocyte settling pattern. Five facilities evaluated a total of 2312 specimens from random healthy adults by CMV Total AB Diagnostic EIA and IHA. Twenty-three specimens were uninterpretable with IHA. Of the remaining 2289 specimens, 51.07% (1169/2289) were positive for antibody to CMV as determined with the CMV Total AB Diagnostic EIA and 49.37% (1130/2289) were positive for antibody to CMV as determined by IHA. The overall agreement between CMV Total AB Diagnostic EIA and IHA was 95.50% (2186/2289). Relative specificity was calculated to be 93.87% [(1159-71)/1159] with a {1} 95% confidence interval of 92.34 to 95.18%. Relative sensitivity was calculated to be 97.17% [(1130-32)/1130] with a 95% confidence interval of 96.03 to 98.06%. In addition, a total of 11 serum specimens from CMV infected pediatric patients was tested and all specimens were positive for anti-CMV with the Abbott CMV Total AB Diagnostic EIA. In conclusion, these data demonstrate that Abbott CMV Total AB Diagnostic EIA is as safe and effective and is substantially equivalent to CETUS CMV IHA. Prepared and submitted (December 22, 1995) by: Mary Spiewak 708/937-5376 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFZ/K954301](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFZ/K954301) **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