510(k) · Cleared
ClearedTri-Combo Parasite Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techlab, Inc. · MHJ Cryptosporidium Spp.
Cleared on Jul 10, 2017 as substantially equivalent to K051929 (Techlab, Inc., 2005) after a 90-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jul 10, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- MHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912408 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912408 | Merifluor-Cryptosporidium/Giardia | Meridian Diagnostics, Inc. | 1991 | — |
| −1 | K051929 | Giardia/Cryptosporidium Chek | Techlab, Inc. | 2005 | — |
| 0 (this device) | K171078 | Tri-Combo Parasite Screen | Techlab, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 MHJ? 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 |
|---|---|---|---|
| * | K051929 | Giardia/Cryptosporidium ChekSummary page 6…nd differences. Similarities Item Device (K171028) Predicate (K051929) Intended Use The TECHLAB® TRl-COMBO PARASITE The GIARDIA/ SCREEN test is… | 2005 |
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?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All MHJ devicesMHJ Cryptosporidium Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MHJ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MHJ
Too few MHJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MHJ
No recall names MHJ since 2007.
Adverse event reports per year · MHJ
No MAUDE report names MHJ 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 | 1 | — | 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® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171078: Tri-Combo Parasite Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171078
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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