510(k) · Cleared
ClearedGiardia/Cryptosporidium Chek
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techlab, Inc. · MHJ Cryptosporidium Spp.
Cleared on Nov 17, 2005 as substantially equivalent to K955157 (Alexon Biomedical, Inc., 1996) and 1 other predicate after a 127-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Nov 17, 2005
- Review
- 127 days
- Class
- Class II
- Product code
- MHJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912408 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K171078Tri-Combo Parasite ScreenTechlab, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912408 | Merifluor-Cryptosporidium/Giardia | Meridian Diagnostics, Inc. | 1991 | — |
| 0 (this device) | K051929 | Giardia/Cryptosporidium Chek | Techlab, Inc. | 2005 | — |
| +1 | K171078 | Tri-Combo Parasite Screen | Techlab, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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 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? (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 |
|---|---|---|---|
| * | K955157 | Prospect Giardia/Cryptosporidium Microplate AssaySummary page 1…ProSpecT®oGiardialCryptosporidiumMicroplate Assay Remel (Lenexa, KS - formerly Alexon Biomedical, Inc.) K955 157 MeriflUor TM Cryposporidium/ GiardiaKit Meridian Diagnostics (Cinc… | 1996 |
| * | K912408 | Merifluor-Cryptosporidium/GiardiaSummary page 1…MeriflUor TM Cryposporidium/ GiardiaKit Meridian Diagnostics (Cincinnati, Ohio) K912408 Intended Use The GIARDIA/CRYPTOSPORIDIUM CHEKTM test is an enzyme immunoassay for the qualitative detection of Giardiacyst a… | 1991 |
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 |
|---|---|---|---|
| K171078 | Tri-Combo Parasite Screen | 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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K171078 (Techlab, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MHJ devicesMHJ Cryptosporidium Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 GIARDIA/CRYPTOSPORIDIUM CHEK TM test is an enzyme immunoassay for the
qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal
specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of
Giardia and/or Cryptosporidium gastrointestinal infections.
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/K051929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051929: Giardia/Cryptosporidium Chek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051929
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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