Cleared Special

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (K163554) - FDA 510(k) Clearance

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K163554 · Immunostics Inc., · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
29d
Days
Class 2
Risk

K163554 is an FDA 510(k) clearance for the hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on January 17, 2017 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6550 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Immunostics Inc., devices

Submission Details

510(k) Number K163554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2016
Decision Date January 17, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KHE Reagent, Occult Blood
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 18
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K163554.
Instant-view-PLUS immunochemical Fecal Occult Blood Test
K173212 · Alfa Scientific Designs, Inc. · Feb 2018
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · Guangzhou Wondfo Biotech Co., Ltd. · May 2017
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · Roche Diagnostics Corp. · Nov 2003
COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998