# K083464: Premier Campy, Model 618096

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Jan 30, 2009 after 67 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.

## Most influential descendants
- K173219: Campylobacter Chek (2018), 0 descendants of its own

## Indications for use
Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures. Premier CAMPY is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Source page: https://510kreport.com/device/K083464
Methodology: https://510kreport.com/methodology