# K980798: Biosign H. Pylori WB-New One-Step Anti-H. Pylori Antibody Test

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Sep 22, 1998 after 204 days
- Product code: LYR (Helicobacter Pylori)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 25, 2023 · Class II · Z-0702-2024: Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive

## Indications for use
BioSign™ E. pylori WB qualitatively detects anti-H pylori antibody in human whole blood, serum or plasma specimens. The test is intended for use in the diagnosis of Helicobacter pylori infection in patients with symptoms of gastrointestinal disorders.

Source page: https://510kreport.com/device/K980798
Methodology: https://510kreport.com/methodology