# ImmunoCyt (urine immunocytology for bladder cancer)

Source: https://onco.cc/drugs/immunocyt/  
OnCo record `immunocyt` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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).

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Also known as: IMMUNOCYT
- Tags: test; screening-test
- 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: US 2000: Immunocytology tumour-marker test for monitoring bladder cancer, 510(k) K994356

## Sources

- FDA 510(k) K994356: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K994356
- He et al., Oncology Letters 2016 (ImmunoCyt meta-analysis): https://doi.org/10.3892/ol.2016.4556

## Connected records

- collections: [FDA medical device databases (PMA, 510(k), De Novo)](https://onco.cc/collections/fda-device-databases/)
- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [Urine tests for bladder cancer (cytology, FISH, RNA and methylation)](https://onco.cc/technologies/urine-bladder-cancer-tests/)
- terms: [Screening](https://onco.cc/terms/screening/)

---
JSON: https://onco.cc/api/v1/entities/immunocyt.json