# K960183: Flexsure HP,Controls for Flexsurehp,Flexpack HP (Abbott Diagnostics)Andcontrols for Flexpack HP (Abbott Diagnostics)

- Pathway: 510(k) (Traditional)
- Applicant: Smithkline Diagnostics, Inc.
- Decided: Jun 7, 1996 after 143 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 K934863 (1994). 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)
- K934863: Flexsure HP, Smithkline Diagnostics, Inc. (1994) Summary page 1.

## Indications for use
The FlexSure® HP test for IgG antibodies to H. pylori in whole blood is a rapid, visually read, qualitative immunochromatographic method. The test is for use by health professionals as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease.

Source page: https://510kreport.com/device/K960183
Methodology: https://510kreport.com/methodology