# K014038: Pyloritek VP Test Kit 5140VP

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: Feb 8, 2002 after 63 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 K953632 (1995). 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)
- K953632: Serim Pyloritek Test Kit, Serim Research Corp. (1995) Summary page 1.

## Indications for use
The PyloriTek VP Test Kit includes materials for detection of urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori. This test is for use on symptomatic patients by healthcare professionals.

Source page: https://510kreport.com/device/K014038
Methodology: https://510kreport.com/methodology