510(k) · Cleared
ClearedE. Histolytica II
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 Dec 21, 1999 after a 15-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Dec 21, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- KHW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK994101 E. Histolytica IITechlab, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK170728 E. Histolytica Quik ChekTechlab, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170728E. Histolytica Quik ChekTechlab, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994101 | E. Histolytica II | Techlab, Inc. | 1999 | — |
| +1 | K170728 | E. Histolytica Quik Chek | Techlab, 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 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170728 | E. Histolytica Quik Chek | 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?
- Of its descendants, K170728 (Techlab, Inc., 2017) has gone furthest, with 0 descendants of its own.
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 I is an enzyme immunoassay for the rapid detection of the adhesin of E. histolytica in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea or dysentery to determine the presence of E. histolytica gastrointestinal infection. The test can be used for fecal specimens submitted for routine clinical testing from adults or children. Conventional microscopy is not a prerequisite for use of the test. FOR IN VITRO DIAGNOSTIC USE.
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/K994101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994101: E. Histolytica II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994101
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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