# K191147: OC-Auto SENSOR io iFOB Test

- Pathway: 510(k) (Traditional)
- Applicant: Eiken Chemical Co., Ltd.
- Decided: Jan 2, 2020 after 247 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
Longest line of descent: 1 generation back to K092330 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092330: OC-Sensor Diana Ifob Test, Polymedco Cancer Diagnostics, LLC (2010) Summary page 4.

## Indications for use
"OC-Auto Sensor io iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitatitve detection of fecal occult blood in feces by professional laboratories. The automated test is used for the measurement of fecal occult blood and is useful as an aid to detect blood in stool when lower gastrointestinal bleeding may be suspected.

Source page: https://510kreport.com/device/K191147
Methodology: https://510kreport.com/methodology