Cleared Traditional

K110309 - FOB ONE STEP RAPID TEST

K110309 is the FDA 510(k) clearance for FOB ONE STEP RAPID TEST by Orient Gene Biotech. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K110309 · Orient Gene Biotech · Hematology device
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Optimized for regulatory review, auditing and printing
Sep 2011
Decision
224d
Days
Class 2
Risk

K110309 is an FDA 510(k) clearance for the FOB ONE STEP RAPID TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Orient Gene Biotech (East Stroudsburg, US). The FDA issued a Cleared decision on September 14, 2011 after a review of 224 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6550 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Orient Gene Biotech devices

Submission Details

510(k) Number K110309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2011
Decision Date September 14, 2011
Days to Decision 224 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 113d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 28
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K110309.
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
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
K100817 · Princeton BioMeditech Corp. · Jul 2010
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · Alfa Scientific Designs, Inc. · Jun 2007
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
K061065 · Teco Diagnostics · Jul 2006