510(k) · Cleared
ClearedLeuko EZ Vue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techlab Inc., Corporate Research Center · DEG Lactoferrin, Antigen, Antiserum, Control
Cleared on Dec 4, 2007 as substantially equivalent to K931241 (Techlab, Inc., 1994) after a 165-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Dec 4, 2007
- Review
- 165 days
- Class
- Class I
- Product code
- DEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931241 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK931241 Fast'n'flammatory KitTechlab, Inc. · 1994
- This deviceK071712 Leuko EZ VueTechlab Inc., Corporate Research Center · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931241 | Fast'n'flammatory Kit | Techlab, Inc. | 1994 | — |
| 0 (this device) | K071712 | Leuko EZ Vue | Techlab Inc., Corporate Research Center | 2007 | — |
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 DEG? 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? (2)
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 |
|---|---|---|---|
| * | K931241 | Fast'n'flammatory KitSummary page 1…19, 2007 Product and Trade Name TECHLAB® LEUKO EZ VUET M Classification Class 1,21 CFR 866.5570 Predicate Devices * TECHLAB® LEUKO-TEST (K931241/Al). The LEUKO-TEST is a latex agglutination test for detecting elevated levels of fecal lactoferrin as a marker of… | 1994 |
| * | — | Methylene Blue stain and Gram stain along with microscopic observation Named without a submission number |
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 DEG devicesDEG Lactoferrin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DEG
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DEG
Too few DEG 510(k)s in any year since 2007 to give a median.
Recalls per year · DEG
No recall names DEG since 2007.
Adverse event reports per year · DEG
No MAUDE report names DEG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LEUKO EZ VUE™ test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE™ test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing.
FOR IN VITRO DIAGNOSTIC USE.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071712 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071712: Leuko EZ Vue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071712
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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