Bladder cancer monitoring uses tumour markers and immunohistochemistry techniques to diagnose patients with non-muscle invasive bladder cancer. Key tests include the Bladder Cancer Monitor, which diagnoses patients with a history of non-muscle invasive bladder cancer NMIBC. Urine tests identify tumour markers produced by bladder cancer cells. IHC is used to evaluate bladder cancer stage and grade. A combination of cystoscopy and urine biomarkers, including NMP-22 tests, has shown effectiveness in increasing bladder cancer detection rates.

Immunohistochemistry test systems (IHCs) are in vitro diagnostic devices made of polyclonal or monoclonal antibodies. They are used to identify antigens in tissues or cytologic specimens using immunological techniques.

IHCs are classified into three categories: Class I (general controls), Class II (special control), and Class III (premarket approval). Class I IHCs provide adjunctive diagnostic information that is not usually reported as an independent finding. They are used after conventional histopathology has made the primary diagnosis of tumor. Class II IHCs are intended for the detection and measurement of certain target analytes to provide prognostic or predictive data that are not directly confirmed by routine histopathologic specimens. Class III IHCs are intended for any use not described in these categories.

Intended Use

Immunocyte is a qualitative direct immunocytofluorescence assay intended for use in conjunction with cytology to increase the overall sensitivity for the detection of tumour cells exfoliated in the urine of patients previously diagnosed with bladder cancer. ImmunoCyt is indicated for use as an aid in the management of bladder cancer in conjunction with urinary cytology and cystoscopy.

Device Description

ImmunoCyt IVD devices use three monoclonal antibodies to detect tumour cells in bladder cancer patients’ urine. Two antibodies are reactive to mucin found in bladder cancer cells, while one reacts with a glycosylated form of the carcinoembryonic antigen. The antibodies are coupled with fluorescent markers, and the device also includes a sample fixative, blocking solution, and positive and negative control cells. The blocking solution minimises the non-specific binding of antibodies, while the sample fixative stabilizes the pH and reduces potential artefacts in staining. Positive and negative control cells serve as qualitative indicators for each test sample preparation.

• Stability Studies
• Precision/Reproducibility
• Detection studies
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Retrospective Study
• Analytical Sensitivity
• Assay cut-off.
• Analytical Specificity (Cross-Reactivity)
• Interfering Substances
• Precision – Intra and Inter-assay
• Prozone effect study

The same is applicable for CE Marking under IVDR also.

No Guidance available  for 510k submission and IVDR CE Marking