510(k) · Cleared
ClearedE. Histolytica Quik Chek
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 Jun 7, 2017 as substantially equivalent to K994101 (Techlab, Inc., 1999) after a 90-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 7, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- KHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K994101 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK994101 E. Histolytica IITechlab, Inc. · 1999
- This deviceK170728 E. Histolytica Quik ChekTechlab, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994101 | E. Histolytica II | Techlab, Inc. | 1999 | — |
| 0 (this device) | K170728 | E. Histolytica Quik Chek | Techlab, Inc. | 2017 | — |
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? (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 |
|---|---|---|---|
| * | K994101 | E. Histolytica IISummary page 6…Similarities E. HISTOLYTICA II™ E. HISTOLYTICA QUIK CHEK™ Item (K994101) (K170028) The E. HISTOLYTICA II™ is an enzyme The TECHLAB E. HI… | 1999 |
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 KHW devicesKHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 TECHLAB E. HISTOLYTICA QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of adhesin from Entamoeba histolytica in a single use cassette. It is intended for use with human fecal specimens from patients with diarrhea or dysentery as an aid in the diagnosis of E. histolytica gastrointestinal infection. Test results should be considered in conjunction with patient history.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170728 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170728: E. Histolytica Quik Chek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170728
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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