510(k) · Cleared
ClearedOC-Auto SENSOR io iFOB Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eiken Chemical Co., Ltd. · OOX Automated Occult Blood Analyzer
Cleared on Jan 2, 2020 as substantially equivalent to K092330 (Polymedco Cancer Diagnostics, LLC, 2010) after a 247-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Jan 2, 2020
- Review
- 247 days
- Class
- Class II
- Product code
- OOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092330 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK092330 OC-Sensor Diana Ifob TestPolymedco Cancer Diagnostics, LLC · 2010
- This deviceK191147 OC-Auto SENSOR io iFOB TestEiken Chemical Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092330 | OC-Sensor Diana Ifob Test | Polymedco Cancer Diagnostics, LLC | 2010 | — |
| 0 (this device) | K191147 | OC-Auto SENSOR io iFOB Test | Eiken Chemical Co., Ltd. | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OOX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OOX device
- #1 K200754 Hemosure Accu-Reader A100score 3.4 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092330 | OC-Sensor Diana Ifob TestSummary page 4…K191147 Manufacturer: Eiken Chemical Co., Ltd. Predicate Device Information: Trade Name: OC-Sensor DIANA iFOB Test 510(k) Number: K092330 510(k) Applicant: Eiken Chemical Co., Ltd. Manufacturer: Eiken Chemical Co., Ltd. Repackager/Relabeler: Polymedco Inc… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All OOX devicesOOX Automated Occult Blood Analyzer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OOX
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OOX
Too few OOX 510(k)s in any year since 2007 to give a median.
Recalls per year · OOX
No recall names OOX since 2007.
Adverse event reports per year · OOX
No MAUDE report names OOX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
"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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191147: OC-Auto SENSOR io iFOB Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191147
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026