510(k) · Cleared
ClearedIvd Giardia Antigen Detection Assay Model GL-96
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivd Research, Inc. · MHI Giardia Spp.
Cleared on Sep 17, 2002 after a 208-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 17, 2002
- Review
- 208 days
- Class
- Class II
- Product code
- MHI
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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.
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?
This ELISA is an in vitro immunoassay for the qualitative determination of Giardia antigen in feces. It is a double antibody (sandwich) ELISA using an anti-Giardia antibody to capture the antigen from the stool supernatant. A second anti-Giardia antibody is then added which sandwiches the captured antigen. This reaction is visualized by the addition of an anti-second antibody conjugated to peroxidase and the chromogen tetramethylbenzidine (TMB). The resulting blue color development indicates the presence of Giardia antigens being bound by the anti-Giardia antibodies.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K020583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020583: Ivd Giardia Antigen Detection Assay Model GL-96.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020583
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026