510(k) · Cleared
Recalled · Class II · 2025Giardia/Cryptosporidium Combo Rapid Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Diagnostics · MHI Giardia Spp.
Cleared on Jan 11, 1999 after a 105-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 11, 1999
- Review
- 105 days
- Class
- Class II
- Product code
- MHI
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK983399 Giardia/Cryptosporidium Combo Rapid AssayGenzyme Diagnostics · 1999
- Descendant · cites it directly · 2 of its ownK031942 Xpect Giardia Lateral Flow Assay, Model 2450020Remel, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK031965 Xpect Cryptosporidium Lateral Flow Assay, Model 2451020Remel, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK120001 Unigold GiardiaTrinity Biotech · 2013
- Descendant · 2 generations on · 0 of its ownK121565 Uni-Gold CryptosporidiumTrinity Biotech · 2013
- Descendant · 2 generations on · 0 of its ownK081064 Giardia Fecal Antigen Detection Lateral Flow Kit, Model GL-LFIvd Research, Inc. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031942Xpect Giardia Lateral Flow Assay, Model 2450020Remel, Inc. · 2003 · cites it directly2descendants
- K031965Xpect Cryptosporidium Lateral Flow Assay, Model 2451020Remel, Inc. · 2003 · cites it directly1descendant
- K120001Unigold GiardiaTrinity Biotech · 2013 · 2 generations on0descendants
- K121565Uni-Gold CryptosporidiumTrinity Biotech · 2013 · 2 generations on0descendants
- K081064Giardia Fecal Antigen Detection Lateral Flow Kit, Model GL-LFIvd Research, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983399 | Giardia/Cryptosporidium Combo Rapid Assay | Genzyme Diagnostics | 1999 | — |
| +1 | K031942 | Xpect Giardia Lateral Flow Assay, Model 2450020 | Remel, Inc. | 2003 | — |
| +1 | K031965 | Xpect Cryptosporidium Lateral Flow Assay, Model 2451020 | Remel, Inc. | 2003 | 1 |
| +2 | K120001 | Unigold Giardia | Trinity Biotech | 2013 | — |
| +2 | K121565 | Uni-Gold Cryptosporidium | Trinity Biotech | 2013 | — |
| +2 | K081064 | Giardia Fecal Antigen Detection Lateral Flow Kit, Model GL-LF | Ivd Research, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 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 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 |
|---|---|---|---|
| * | — | Alexon ProSpecT Named without a submission number |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2025 | Class II | Z-1719-2025 | Under Investigation by firm | A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements. |
| Feb 23, 2004 | Not classified | Z-0770-04 | Other | False Positive results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031942 (Remel, Inc., 2003) has gone furthest, with 2 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?
This is an immunochromatographic assay for the simultaneous qualitative detection and distinguishing of Giardia and Cryptosporidium specific antigens in aqueous extracts of fecal specimens.
It is intended for professional laboratory use.
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/K983399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983399: Giardia/Cryptosporidium Combo Rapid Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983399
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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