510(k) · Cleared
ClearedOsom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SEKISUI Diagnostics, LLC · KHE Reagent, Occult Blood
Cleared on Dec 28, 2012 as substantially equivalent to K021423 (Alfa Scientific Designs, Inc., 2002) after a 233-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Dec 28, 2012
- Review
- 233 days
- Class
- Class II
- Product code
- KHE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K880499 (1988). No later device cites it as a predicate yet.
- Root · 2 generations backK880499 Hemoccult Sensitive TestSmithkline Diagnostics, Inc. · 1988
- 1 generation backK021423 Instant-View Fecal Occult Blood Rapid TestAlfa Scientific Designs, Inc. · 2002
- This deviceK121397 Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit…SEKISUI Diagnostics, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880499 | Hemoccult Sensitive Test | Smithkline Diagnostics, Inc. | 1988 | — |
| −1 | K021423 | Instant-View Fecal Occult Blood Rapid Test | Alfa Scientific Designs, Inc. | 2002 | — |
| 0 (this device) | K121397 | Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob… | SEKISUI Diagnostics, LLC | 2012 | — |
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 KHE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K021423 | Instant-View Fecal Occult Blood Rapid TestSummary page 1…Occult blood test Product Code: KTEE Classification: Class II 3. Predicate Device K02 1423 - Alfa Scientific Designs' Instant-View Fecal Occult Blood Rapid Test (Currently marketed as Quidel QuickVue iFOB Test).… | 2002 |
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?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K021423.
How does its category compare?
All KHE devicesKHE Reagent, Occult Blood: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KHE
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KHE
126in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHE
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHE
3in 2025
MAUDE reports naming product code KHE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 104 | 0 | 3 |
| 2008 | 3 | 93 | 1 | 5 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 2 | — | 6 | 4 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 0 | — | 2 | 16 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 1 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 4 | 126 | 0 | 1 |
| 2018 | 1 | — | 1 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OSOM iFOBT Control Kit is intended for use in quality control testing with the OSOM iFOB Test.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121397 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121397: Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121397
Report an extraction error
Are you the manufacturer?
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