510(k) · Cleared
ClearedI-Chroma Ifob with I-Chroma Reader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boditech Med, Inc. · OOX Automated Occult Blood Analyzer
Cleared on May 2, 2014 as substantially equivalent to K041408 (Polymedco, Inc., 2004) after a 294-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- May 2, 2014
- Review
- 294 days
- Class
- Class II
- Product code
- OOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041408 (2004). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K163225AFIAS iFOB with AFIAS-50Immunostics Inc., · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041408 | Polymedco OC Auto Micro 80 Fob Test | Polymedco, Inc. | 2004 | — |
| 0 (this device) | K132167 | I-Chroma Ifob with I-Chroma Reader | Boditech Med, Inc. | 2014 | — |
| +1 | K163225 | AFIAS iFOB with AFIAS-50 | Immunostics Inc., | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
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
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K041408 | Polymedco OC Auto Micro 80 Fob TestSummary page 1…: OOX Regulation: 21 CFR § 864.6550 Predicate Device: OC Auto Micro FOB Test and Polymedco OC Auto Micro 80 Analyzer Predicate K Number: K04 1408 Device Description: i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immuno- chromatographic assay system for… | 2004 |
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 |
|---|---|---|---|
| K163225 | AFIAS iFOB with AFIAS-50 | 2017 | 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?
How does its category compare?
All OOX devicesOOX Automated Occult Blood Analyzer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
i-CH-ROMA IFOB Controls are external quality control reagents intended for monitoring and ensuring acceptable performance of i-CHROMA iFOB test system which is a qualitative in-vitro diagnostic test for detection of focal occult blood having an analytical cut-off of 100 ng/mL which is equivalent to 8ptg i.e. 0.008 mg hemoglobin per gram of stool. i-CHROMA IFOB in conjunction with i-CH-ROMA Reader is a fluorescence inimuno-chromatographic assay system for…
Read the full statement (102 words)
i-CH-ROMA IFOB Controls are external quality control reagents intended for monitoring and ensuring acceptable performance of i-CHROMA iFOB test system which is a qualitative in-vitro diagnostic test for detection of focal occult blood having an analytical cut-off of 100 ng/mL which is equivalent to 8ptg i.e. 0.008 mg hemoglobin per gram of stool.
i-CHROMA IFOB in conjunction with i-CH-ROMA Reader is a fluorescence inimuno-chromatographic assay system for qualitative detection of fecal occult blood (FOB) in human focal samples.
i-CHROMA iFOB is an in vitro diagnostic test used by laboratories and physician offices for routine physical examination when gastrointestinal bleeding may be suspected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132167 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132167: I-Chroma Ifob with I-Chroma Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132167
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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