510(k) · Cleared
ClearedIvd Crypto/Giardia Dfa
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 Mar 5, 2003 as substantially equivalent to K912408 (Meridian Diagnostics, Inc., 1991) after an 82-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Mar 5, 2003
- Review
- 82 days
- Class
- Class II
- Product code
- MHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912408 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912408 Merifluor-Cryptosporidium/GiardiaMeridian Diagnostics, Inc. · 1991
- This deviceK024113 Ivd Crypto/Giardia DfaIvd Research, Inc. · 2003
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) | K024113 | Ivd Crypto/Giardia Dfa | Ivd Research, Inc. | 2003 | — |
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 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? (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 |
|---|---|---|---|
| * | K912408 | Merifluor-Cryptosporidium/GiardiaSummary page 1…Entamoeba histolytica serological reagents Predicate Device: Meridian Diagnostic’s Merifluor TM CryptosporidiumlGiardia Direct Fluorescent Antigen Detection Kit, 510(k) K912408 DESCRIPTION AND PRINCIPLE: This IVD Research, Inc. CryptosporidiumlGiardia Direct Fluorescent Antigen Detection Kit (DFA Assay… | 1991 |
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.
- 2 other devices also cite its predicate K912408.
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 direct fluorescent antigen (DFA) detection kit is an in vitro diagnostic (IVD) immunoassay for the detection of Cryptosporidium oocysts and Giardia Cysts in human feces using fluorescent microscopic visualization. This IVD assay is intended to be used with stools preserved in 10% formalin, SAF or Medical Chemical Corporation’s (MCC’s ) Universal fixative. Such samples may be concentrated or unconcentrated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024113: Ivd Crypto/Giardia Dfa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024113
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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