510(k) · Cleared
ClearedInstant-View Fecal Occult Blood (Fob) Rapid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Scientific Designs, Inc. · KHE Reagent, Occult Blood
Cleared on Jun 21, 2007 as substantially equivalent to K880499 (Smithkline Diagnostics, Inc., 1988) after a 104-day review. Its family tree reaches back 1 generation to 1988. 3 later devices descend from it.
- Decided
- Jun 21, 2007
- Review
- 104 days
- Class
- Class II
- Product code
- KHE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880499 (1988). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK880499 Hemoccult Sensitive TestSmithkline Diagnostics, Inc. · 1988
- This deviceK070660 Instant-View Fecal Occult Blood (Fob) Rapid TestAlfa Scientific Designs, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK110309 Fob One Step Rapid TestOrient Gene Biotech · 2011
- Descendant · cites it directly · 0 of its ownK173212 Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK162333 Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See all- K110309Fob One Step Rapid TestOrient Gene Biotech · 2011 · cites it directly1descendant
- K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc. · 2018 · cites it directly0descendants
- K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880499 | Hemoccult Sensitive Test | Smithkline Diagnostics, Inc. | 1988 | — |
| 0 (this device) | K070660 | Instant-View Fecal Occult Blood (Fob) Rapid Test | Alfa Scientific Designs, Inc. | 2007 | — |
| +1 | K110309 | Fob One Step Rapid Test | Orient Gene Biotech | 2011 | — |
| +1 | K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Alfa Scientific Designs, Inc. | 2018 | — |
| +2 | K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | Guangzhou Wondfo Biotech Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 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 |
|---|---|---|---|
| * | K880499 | Hemoccult Sensitive TestSummary page 1…Test Product Code: NGK Date of SummaryDembr2 06 PreparationDeebr2,06 Predicate Device 510K Number: K880499 Hemoccult® test by Beckman Coulter, Inc. Device is a one-step lateral flow… | 1988 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 KHE devicesKHE Reagent, Occult Blood: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 INSTANT-VIEW Fecal Occult Blood (FOB) Self-Test is a qualitative 'mxnunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as a self-test product. Measurement of FOB is useful as an aid to detect human blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps and colorectal cancer. It is intended for over the counter use. The Fecal Occult Blood (FOB) Self-Test is a…
Read the full statement (125 words)
The INSTANT-VIEW Fecal Occult Blood (FOB) Self-Test is a qualitative 'mxnunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as a self-test product. Measurement of FOB is useful as an aid to detect human blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps and colorectal cancer. It is intended for over the counter use.
The Fecal Occult Blood (FOB) Self-Test is a qualitative immunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as a self-test product. Measurement of FOB is useful as an aid to detect human blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps and colorectal cancer. It is intended for over the counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070660 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070660: Instant-View Fecal Occult Blood (Fob) Rapid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070660
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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