510(k) · Cleared
ClearedXpect Giardia Lateral Flow Assay, Model 2450020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remel, Inc. · MHI Giardia Spp.
Cleared on Nov 18, 2003 as substantially equivalent to K983399 (Genzyme Diagnostics, 1999) after a 147-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- Nov 18, 2003
- Review
- 147 days
- Class
- Class II
- Product code
- MHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983399 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983399 Giardia/Cryptosporidium Combo Rapid AssayGenzyme Diagnostics · 1999 · Recalled
- This deviceK031942 Xpect Giardia Lateral Flow Assay, Model 2450020Remel, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK120001 Unigold GiardiaTrinity Biotech · 2013
- Descendant · cites it directly · 0 of its ownK081064 Giardia Fecal Antigen Detection Lateral Flow Kit, Model GL-LFIvd Research, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983399 | Giardia/Cryptosporidium Combo Rapid Assay | Genzyme Diagnostics | 1999 | 2 |
| 0 (this device) | K031942 | Xpect Giardia Lateral Flow Assay, Model 2450020 | Remel, Inc. | 2003 | — |
| +1 | K120001 | Unigold Giardia | Trinity Biotech | 2013 | — |
| +1 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 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 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 |
|---|---|---|---|
| * | K983399 | Giardia/Cryptosporidium Combo Rapid AssaySummary page 1…pectTM Giardia Lateral Flow Assay Predicate Device: Becton Dickinson ColorPACTM GiardidCryptosporidium Rapid Assay, (k)983399. Classification Name: Entamoeba histolytica serological reagents. Giardia SPP 866.3220 Code: MHI Intend… | 1999 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
REMEL's Xpect™Giardia kit is an in vitro qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia 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/K031942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031942: Xpect Giardia Lateral Flow Assay, Model 2450020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031942
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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