# K961062: Flexsure Obt

- Pathway: 510(k) (Traditional)
- Applicant: Smithkline Diagnostics, Inc.
- Decided: Nov 6, 1996 after 233 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- 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. The FDA summary names its predicate without a number.
- (no number) Hemoccult Routine Screening Test for Fecal Occult Blood: named in the summary without a submission number

## Indications for use
The FlexSure OBT (Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin from blood in fecal samples. Fecal occult blood tests are useful screening aids for detecting primarily lower gastrointestinal (g.i.) disorders that may be related to iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other g.i. lesions that can bleed. FlexSure OBT is recommended for use by health professionals as part of routine physical examinations or when lower g.i. disorders are suspected.

Source page: https://510kreport.com/device/K961062
Methodology: https://510kreport.com/methodology