# K982315: Prospect Campylobacter Microplate Assay

- Pathway: 510(k) (Traditional)
- Applicant: Alexon - Trend, Inc.
- Decided: Nov 18, 1998 after 140 days
- Product code: LQP (Campylobacter Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K090700: Immunocard Stat Campy, Model 751530 (2009), 1 descendant of its own
- K083464: Premier Campy, Model 618096 (2009), 1 descendant of its own
- K173219: Campylobacter Chek (2018), 0 descendants of its own
- K173217: Campylobacter Quik Chek (2018), 0 descendants of its own

## Recalls of this device
- Jul 15, 2002 · Not classified · Z-1372-04: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K982315
Methodology: https://510kreport.com/methodology