# K024350: Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Apr 2, 2003 after 93 days
- Product code: LYR (Helicobacter Pylori)
- 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 K934863 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991747: Quickvue One-Step H. Pylori II Test, Quidel Corp. (1999) Summary page 3.
- K934863: Flexsure HP, Smithkline Diagnostics, Inc. (1994) Summary page 4.

## Most influential descendants
- K151935: Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only (2015), 0 descendants of its own

## Indications for use
The ACON H. pylori Rapid Test Strip and ACON H. pylori Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of antibodies specific to H. pylori in human whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. They are intended for healthcare professionals and professionals at point of care sites only.

Source page: https://510kreport.com/device/K024350
Methodology: https://510kreport.com/methodology