510(k) · Cleared
Recalled · 2002Xpect Cryptosporidium Lateral Flow Assay, Model 2451020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remel, Inc. · MHJ Cryptosporidium Spp.
Cleared on Nov 14, 2003 as substantially equivalent to K983399 (Genzyme Diagnostics, 1999) after a 141-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 14, 2003
- Review
- 141 days
- Class
- Class II
- Product code
- MHJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983399 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK983399 Giardia/Cryptosporidium Combo Rapid AssayGenzyme Diagnostics · 1999 · Recalled
- This deviceK031965 Xpect Cryptosporidium Lateral Flow Assay, Model 2451020Remel, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK121565 Uni-Gold CryptosporidiumTrinity Biotech · 2013
Most influential descendants
Showing 1 of 1 · See all- K121565Uni-Gold CryptosporidiumTrinity Biotech · 2013 · cites it directly0descendants
View 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) | K031965 | Xpect Cryptosporidium Lateral Flow Assay, Model 2451020 | Remel, Inc. | 2003 | — |
| +1 | K121565 | Uni-Gold Cryptosporidium | Trinity Biotech | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MHJ? 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…ryptosporidium Lateral Flow Assay Predicate Device: Becton Dickinson ColorPACTM GiardidCryptosporidium Rapid Assay, (k)983399. Classification Name: Entamoeba histolytica serological reagents. Cryptosporidium SPP 866.3220 Code: MHJ… | 1999 |
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 |
|---|---|---|---|
| K121565 | Uni-Gold Cryptosporidium | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2002 | Not classified | Z-1376-04 | Other | A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may NOT perform as intended through its expiration date and may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MHJ devicesMHJ Cryptosporidium Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHJ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MHJ
Too few MHJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MHJ
No recall names MHJ since 2007.
Adverse event reports per year · MHJ
No MAUDE report names MHJ 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 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 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
REMEL’s XpectTMCryptosporidium kit is an in vitro qualitative immunoassay for the detection of Cryptosporidium antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Cryptosporidium infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031965 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031965: Xpect Cryptosporidium Lateral Flow Assay, Model 2451020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031965
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