# K171484: hema-screen SPECIFIC Gold

- Pathway: 510(k) (Special)
- Applicant: Immunostics Inc.,
- Decided: Jun 14, 2017 after 23 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
Longest line of descent: 1 generation back to K060463 (2006). 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)
- K060463: Hema Screen Specific Ifobt, Immunostics Inc., (2006) Summary page 4.

## Indications for use
The Hema-Screen™ Specific Gold 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 (GI) 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/K171484
Methodology: https://510kreport.com/methodology