Cleared Traditional

K063693 - FORSURE ONE STEP FECAL OCCULT BLOOD (FO...

K063693 is the FDA 510(k) clearance for FORSURE ONE STEP FECAL OCCULT BLOOD (FO... by New Bay Bioresearch Co. , Ltd.. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K063693 · New Bay Bioresearch Co. , Ltd. · Hematology device
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May 2007
Decision
149d
Days
Class 2
Risk

K063693 is an FDA 510(k) clearance for the FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by New Bay Bioresearch Co. , Ltd. (Carlsbad, US). The FDA issued a Cleared decision on May 11, 2007 after a review of 149 days - within the typical 510(k) review window.

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 New Bay Bioresearch Co. , Ltd. devices

Submission Details

510(k) Number K063693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2006
Decision Date May 11, 2007
Days to Decision 149 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
36d slower than avg
Panel avg: 113d · This submission: 149d
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 K063693.
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
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · Roche Diagnostics Corp. · Nov 2003
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423 · Alfa Scientific Designs, Inc. · Jun 2002