510(k) · Cleared
ClearedOC-Sensor Diana Ifob Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymedco Cancer Diagnostics, LLC · OOX Automated Occult Blood Analyzer
Cleared on Jan 8, 2010 after a 157-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jan 8, 2010
- Review
- 157 days
- Class
- Class II
- Product code
- OOX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK092330 OC-Sensor Diana Ifob TestPolymedco Cancer Diagnostics, LLC · 2010
- Descendant · cites it directly · 0 of its ownK191147 OC-Auto SENSOR io iFOB TestEiken Chemical Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K191147OC-Auto SENSOR io iFOB TestEiken Chemical Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092330 | OC-Sensor Diana Ifob Test | Polymedco Cancer Diagnostics, LLC | 2010 | — |
| +1 | K191147 | OC-Auto SENSOR io iFOB Test | Eiken Chemical Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191147 | OC-Auto SENSOR io iFOB Test | 2020 | 0 |
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?
- Of its descendants, K191147 (Eiken Chemical Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OOX devicesOOX Automated Occult Blood Analyzer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
"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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092330 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092330: OC-Sensor Diana Ifob Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092330
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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