Cleared Traditional

K063693 - FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST

K063693 is an FDA 510(k) clearance for FORSURE ONE STEP FECAL OCCULT BLOOD (FO..., manufactured by New Bay Bioresearch Co. , Ltd.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K063693

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
Combination Product No
PCCP Authorized No
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.

KHE Device Classification - Class 2, Special Controls

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 60
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K063693.
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
DBEST ONE STEP OCCULT BLOOD TEST KITS
K071242 · Ameritek USA, Inc. · Mar 2008
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · Alfa Scientific Designs, Inc. · Jun 2007
INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
K063673 · Innovacon, Inc. · Mar 2007
OCCULTECH FECAL OCCULT BLOOD RAPID TEST
K060953 · Yd Diagnostics Corp. · Sep 2006
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
K061065 · Teco Diagnostics · Jul 2006