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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.
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).
Antibody staining of cells from a urine sample (immunocytology), read alongside conventional urine cytology.
| Region | Year | Indication |
|---|---|---|
| US | 2000 | Immunocytology tumour-marker test for monitoring bladder cancer, 510(k) K994356 |
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Query for this drug: (TITLE:"ImmunoCyt" OR ABSTRACT:"ImmunoCyt" OR TITLE:"urine immunocytology for bladder cancer" OR ABSTRACT:"urine immunocytology for bladder cancer" OR TITLE:"IMMUNOCYT" OR ABSTRACT:"IMMUNOCYT") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about ImmunoCyt (urine immunocytology for bladder cancer), not a curated reading list.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
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