{"entity":{"id":"immunocyt","kind":"drug","name":"ImmunoCyt (urine immunocytology for bladder cancer)","aka":["IMMUNOCYT"],"tldr":"A urine cell test cleared by the FDA in 2000 for monitoring bladder cancer; with ordinary urine cytology it finds more cancers than cytology alone, at the cost of more false positives.","summary":"IMMUNOCYT (Diagnocure) was cleared by the FDA on 23 February 2000 (510(k) K994356) under the product code for immunohistochemistry tumour-marker tests for monitoring bladder cancer (21 CFR 864.1860, class II). A meta-analysis of seven studies with 1,602 patients with bladder cancer found pooled sensitivity of 72.5% for ImmunoCyt against 56.6% for urine cytology, with lower specificity; ImmunoCyt and cytology combined had a pooled sensitivity of 83.3% and specificity of 64.4% (He et al., Oncology Letters 2016).","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K994356","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K994356"},{"label":"He et al., Oncology Letters 2016 (ImmunoCyt meta-analysis)","url":"https://doi.org/10.3892/ol.2016.4556"}],"tags":["test","screening-test"],"related":["fda-device-databases"],"cancers":["urothelial"],"sections":["early-detection","diagnostics"],"technologies":["urine-bladder-cancer-tests"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"ImmunoCyt","modality":"Urine immunocytology test (bladder cancer monitoring)","mechanism":"Antibody staining of cells from a urine sample (immunocytology), read alongside conventional urine cytology.","approvals":[{"region":"US","year":2000,"indication":"Immunocytology tumour-marker test for monitoring bladder cancer, 510(k) K994356"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/immunocyt/","neighbours":{"collection":[{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","route":"/collections/fda-device-databases/"}],"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"urine-bladder-cancer-tests","kind":"technology","name":"Urine tests for bladder cancer (cytology, FISH, RNA and methylation)","route":"/technologies/urine-bladder-cancer-tests/"}],"term":[{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}]}}