# K092330: OC-Sensor Diana Ifob Test

- Pathway: 510(k) (Traditional)
- Applicant: Polymedco Cancer Diagnostics, LLC
- Decided: Jan 8, 2010 after 157 days
- Product code: OOX (Automated Occult Blood Analyzer)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K191147: OC-Auto SENSOR io iFOB Test (2020), 0 descendants of its own

## Indications for use
"00-Sensor DIANA iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders (GI), e.g. colitis, polyps, and colorectal cancer. The 00-Sensor DIANA iFOB test is recommended for use in: 1. Routine physical examinations 2. Monitoring bleeding in patients 3. Screening for colorectal cancer or gastrointestinal bleeding

Source page: https://510kreport.com/device/K092330
Methodology: https://510kreport.com/methodology