# K163554: hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

- Pathway: 510(k) (Special)
- Applicant: Immunostics Inc.,
- Decided: Jan 17, 2017 after 29 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 K102664 (2011). 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)
- K102664: Hema Screen ER, Immunostics Inc., (2011) Summary page 4.

## Indications for use
hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

Source page: https://510kreport.com/device/K163554
Methodology: https://510kreport.com/methodology