510(k) · Cleared
Recalled · 2002Prospect Campylobacter Microplate Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alexon - Trend, Inc. · LQP Campylobacter Spp.
Cleared on Nov 18, 1998 after a 140-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 18, 1998
- Review
- 140 days
- Class
- Class I
- Product code
- LQP
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK982315 Prospect Campylobacter Microplate AssayAlexon - Trend, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK090700 Immunocard Stat Campy, Model 751530Meridian Bioscience, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK083464 Premier Campy, Model 618096Meridian Bioscience, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK173219 Campylobacter ChekTechlab, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK173217 Campylobacter Quik ChekTechlab, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K090700Immunocard Stat Campy, Model 751530Meridian Bioscience, Inc. · 2009 · cites it directly1descendant
- K083464Premier Campy, Model 618096Meridian Bioscience, Inc. · 2009 · cites it directly1descendant
- K173219Campylobacter ChekTechlab, Inc. · 2018 · 2 generations on0descendants
- K173217Campylobacter Quik ChekTechlab, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982315 | Prospect Campylobacter Microplate Assay | Alexon - Trend, Inc. | 1998 | — |
| +1 | K090700 | Immunocard Stat Campy, Model 751530 | Meridian Bioscience, Inc. | 2009 | — |
| +1 | K083464 | Premier Campy, Model 618096 | Meridian Bioscience, Inc. | 2009 | — |
| +2 | K173219 | Campylobacter Chek | Techlab, Inc. | 2018 | — |
| +2 | K173217 | Campylobacter Quik Chek | Techlab, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2018 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LQP device
- #1 K210976 Curian Campyscore 2.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2002 | Not classified | Z-1372-04 | Other | A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090700 (Meridian Bioscience, Inc., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LQP devicesLQP Campylobacter Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LQP
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LQP
Too few LQP 510(k)s in any year since 2007 to give a median.
Recalls per year · LQP
No recall names LQP since 2007.
Adverse event reports per year · LQP
No MAUDE report names LQP 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 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 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?
The ProSpecT® Campylobacter Microplate Assay is an in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures. ProSpecT Campylobacter Microplate Assay is intended for use as an aid in the diagnosis of Campylobacter infections.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982315 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982315: Prospect Campylobacter Microplate Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982315
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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