510(k) · Cleared
ClearedIvd Cryptosporidium Antigen Detection Assay, Model CP-96
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivd Research, Inc. · MHJ Cryptosporidium Spp.
Cleared on Jul 10, 2003 as substantially equivalent to K955345 (Lmd Laboratories, 1996) after a 104-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jul 10, 2003
- Review
- 104 days
- Class
- Class II
- Product code
- MHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955345 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955345 LMD Cryptosporidium Antigen DetectionLmd Laboratories · 1996
- This deviceK031059 Ivd Cryptosporidium Antigen Detection Assay, Model CP-96Ivd Research, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955345 | LMD Cryptosporidium Antigen Detection | Lmd Laboratories | 1996 | — |
| 0 (this device) | K031059 | Ivd Cryptosporidium Antigen Detection Assay, Model CP-96 | 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 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 |
|---|---|---|---|
| * | K955345 | LMD Cryptosporidium Antigen DetectionSummary page 1…Microwell ELISA Kit Classification name: Entamoeba histolytica serological reagents Predicate Device: LMD Laboratories’ Cryptosporidium Antigen Detection ELISA, 51O(k) K955345 DESCRIPTION AND PRINCIPLE: This microwell enzyme-linked immunoabsorbant assay (ELISA) detection kit (Cryptosporidlium ELISA Kit)… | 1996 |
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.
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?
This microwell enzyme linked immunoabsorbant assay (ELLISA) detection kit is an in vitro diagnostic (IVD) immunoassay for the detection of Cryptosporidium antigen in human feces using peroxidase as the enzyme. The assay may be read visually or with an ELISA reader. This IVD assay is intended to be used with stools that are fresh, frozen or preserved in 10% formalin, iSAF or Medical Chemical Corporation's (MCC) Universal fixative. Concentrated samples cannot be used with this IVD.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031059: Ivd Cryptosporidium Antigen Detection Assay, Model CP-96.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031059
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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