# K973508: Pylori Detect Igg

- Pathway: 510(k) (Traditional)
- Applicant: Micro Detect, Inc.
- Decided: Mar 10, 1998 after 175 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K110745: Helicobacter Pylori Elisa Igg Test Kit (2012), 0 descendants of its own

## Indications for use
The PYLORI DETECT IgGis a quactative Enzyme Immunoassay( EIA) Kit for the detection of IgG antibodies against H. pylori in human serum. The test is intended as an aid in the diagnosis of infection by H Pylori in patients with gastrointestinal symptoms. FOR IN VITRO DIAGNOSTIC USE ONLY.

Source page: https://510kreport.com/device/K973508
Methodology: https://510kreport.com/methodology