510(k) · Cleared
ClearedGiardia II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techlab, Inc. · MHI Giardia Spp.
Cleared on Nov 4, 2003 after a 25-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Nov 4, 2003
- Review
- 25 days
- Class
- Class II
- Product code
- MHI
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK033274 Giardia IITechlab, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK103673 Giardia/ Cryptosporidium Quik ChekTechlab Inc., Corporate Research Center · 2011
Most influential descendants
Showing 1 of 1 · See all- K103673Giardia/ Cryptosporidium Quik ChekTechlab Inc., Corporate Research Center · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033274 | Giardia II | Techlab, Inc. | 2003 | — |
| +1 | K103673 | Giardia/ Cryptosporidium Quik Chek | Techlab Inc., Corporate Research Center | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHI? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K103673 | Giardia/ Cryptosporidium Quik Chek | 2011 | 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, K103673 (Techlab Inc., Corporate Research Center, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MHI devicesMHI Giardia Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHI
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · MHI
Too few MHI 510(k)s in any year since 2007 to give a median.
Recalls per year · MHI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHI
No MAUDE report names MHI 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 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 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 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GIARDIA I1 test is an enzyme immunoassay for the qualitative detection of Giardia
iambiia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from
patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test
can be used for fecal specimens submitted for routine clinical testing from adults or children. FOR
IN VITRO DIAGNOSTIC USE.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033274 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033274: Giardia II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033274
Report an extraction error
Are you the manufacturer?
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