# K071242: Dbest One Step Occult Blood Test Kits

- Pathway: 510(k) (Traditional)
- Applicant: Ameritek USA, Inc.
- Decided: Mar 6, 2008 after 308 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
dBest One Step Occult Blood Test Kits is a simple immunochromatograpbie assay for rapid, qualitative detection of fecal occult blood by laboratories or physicians office. It is useful as a diagvostic test kit to aid for detection of bleeding caused by a number of gastrointestinal disorders, such as diverticulitis, colitis, polyps and colorectal can;er. dBest One Step Occult Blood Test Kit is recommended for use in 1) Routine physical examinations, 2) Hospital monitoring for gastrointestinal bleeding and 3) Screening for colorectal cancer

Source page: https://510kreport.com/device/K071242
Methodology: https://510kreport.com/methodology