510(k) · Cleared
ClearedE. Histolytica Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techlab, Inc. · KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Cleared on Aug 30, 1996 after a 248-day review. The FDA summary names no predicate by number.
- Decided
- Aug 30, 1996
- Review
- 248 days
- Class
- Class II
- Product code
- KHW
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 KHW? 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?
The FDA summary names no predicate by 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.
How does its category compare?
All KHW devicesKHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHW
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · KHW
Too few KHW 510(k)s in any year since 2007 to give a median.
Recalls per year · KHW
No recall names KHW since 2007.
Adverse event reports per year · KHW
No MAUDE report names KHW 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 | 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 | 1 | — | 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 E. histolytica Test can be used to detect adhesin (also referred to as galactose-inhibitable lectin) produced by strains of E. histolytica. It does not cross-react with the adhesin from E. dispar (formerly known as nonpathogenic E. histolytica). The test can be used to detect the adhesin in fecal specimens from persons suspected of having amebiasis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955895 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955895: E. Histolytica Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955895
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026