# 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

- Pathway: 510(k) (Special)
- Applicant: Alere San Diego, Incorporated
- Decided: Aug 12, 2015 after 29 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: 2 generations back to K934863 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024350: Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device, ACON Laboratories, Inc. (2003) Summary page 6.

## Indications for use
The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

Source page: https://510kreport.com/device/K151935
Methodology: https://510kreport.com/methodology