# K994356: Immunocyt

- Pathway: 510(k) (Traditional)
- Applicant: Diagnocure, Inc.
- Decided: Feb 23, 2000 after 62 days
- Product code: NBK (System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964151 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964151: Bard and Bta Test, Bard Diagnostic Sciences,Inc. (1997) Summary page 1.
- K970353: Aura Tek FDP, Perimmune, Inc. (1997) Summary page 1.

## Indications for use
ImmunoCyt is a qualitative direct immunocytofluorescence assay intended for use in conjunction with cytology to increase the overall sensitivity for the detection of tumor 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.

Source page: https://510kreport.com/device/K994356
Methodology: https://510kreport.com/methodology