# K973523: Accustat H. Pylori One Step Test

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Mar 3, 1998 after 167 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 K953686 (1996). 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)
- K953686: Helisal Rapid Blood Test, Cortecs, Ltd. (1996) Summary page 1.
- (no number) Smith Kline FlexSure HP: named in the summary without a submission number
- (no number) Quidel QuickVue One-Step H. pylori test: named in the summary without a submission number

## Indications for use
The AccuStat™ H. pylori One Step test is a qualitative immunochemical membrane assay for the detection of antibodies to Helicobacter pylori (H. pylori) in whole blood and serum by visual interpretation. The test is for use as an aid in the diagnosis of H. pylori infection in symptomatic patients.

Source page: https://510kreport.com/device/K973523
Methodology: https://510kreport.com/methodology