# K991248: Pronto Dry

- Pathway: 510(k) (Traditional)
- Applicant: Medical Instruments Corporation Mic AG
- Decided: Jun 22, 1999 after 71 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.
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.

## Indications for use
Pronto Dry is intended for use for the detection of urease enzyme in gastric musocal biopsy specimens for the presumptive determination of Helicobacter pylori symptomatic adult patients. Note: fer in vitro diagnostic use only.

Source page: https://510kreport.com/device/K991248
Methodology: https://510kreport.com/methodology