# P230001: ColoSense®

- Pathway: PMA
- Applicant: Geneoscopy, Inc.
- Decided: May 3, 2024 after 469 days
- Product code: SBB (System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 20, 2025 · Class II · Z-2077-2025: Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.

Source page: https://510kreport.com/device/P230001
Methodology: https://510kreport.com/methodology