# K060463: Hema Screen Specific Ifobt

- Pathway: 510(k) (Traditional)
- Applicant: Immunostics Inc.,
- Decided: Jun 6, 2006 after 104 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K171484: hema-screen SPECIFIC Gold (2017), 0 descendants of its own

## Indications for use
The Hema-ScreenT M Specific is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (G I) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

Source page: https://510kreport.com/device/K060463
Methodology: https://510kreport.com/methodology