# K102664: Hema Screen ER

- Pathway: 510(k) (Special)
- Applicant: Immunostics Inc.,
- Decided: Jan 28, 2011 after 135 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
- K163554: hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (2017), 0 descendants of its own

## Indications for use
hema-screenTm ER 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/K102664
Methodology: https://510kreport.com/methodology