# K991747: Quickvue One-Step H. Pylori II Test

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Aug 4, 1999 after 75 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K024350: Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device (2003), 1 descendant of its own
- 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 QuickVue One-Step H. pylori Il Test is intended for the rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in human serum, plasma and whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease. The test is intended for use by health care professionails.

Source page: https://510kreport.com/device/K991747
Methodology: https://510kreport.com/methodology