# K090700: Immunocard Stat Campy, Model 751530

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: May 28, 2009 after 72 days
- Product code: LQP (Campylobacter Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982315 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982315: Prospect Campylobacter Microplate Assay, Alexon - Trend, Inc. (1998) Summary page 1.
- (no number) Premier CAMPY: named in the summary without a submission number

## Most influential descendants
- K173217: Campylobacter Quik Chek (2018), 0 descendants of its own

## Indications for use
ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens in human stool. ImmunoCard STAT! CAMPY detects C. jejuni and C. coli in human stool, where stool may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information available from the patient's clinical evaluation and other diagnostic procedures. ImmunoCard STAT! CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.

Source page: https://510kreport.com/device/K090700
Methodology: https://510kreport.com/methodology