# K110899: Gold Standard Diagnostics H. Pylori Elisa Iga Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Diagnostics
- Decided: Feb 1, 2012 after 308 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 K003794 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003794: Elisa Test, Serology, Micro Detect, Inc. (2001) Summary page 1.

## Indications for use
The Helicobacter pylori (H.pylori) ELISA IgA test kit is intended for the qualitative detection of IgA antibodies to H. pylori in human serum in the adult population. This test is intended as a second test to aid in the diagnosis of H. pylori in patients with gastrointestinal symptoms, in conjunction with clinical findings. It should be performed and interpreted with another assay for detection of lgG antibodies to H. pylon.

Source page: https://510kreport.com/device/K110899
Methodology: https://510kreport.com/methodology