Cleared Traditional

K051806 - CARE FECAL OCCULT BLOOD TEST, MODEL KT313

K051806 is an FDA 510(k) clearance for CARE FECAL OCCULT BLOOD TEST, manufactured by Epitope Diagnostics, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K051806 · Epitope Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
90d
Days
Class 2
Risk

K051806 is an FDA 510(k) clearance for the CARE FECAL OCCULT BLOOD TEST, MODEL KT313. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Epitope Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 3, 2005 after a review of 90 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 Epitope Diagnostics, Inc. devices

FDA 510(k) Submission Details - K051806

510(k) Number K051806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2005
Decision Date October 03, 2005
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
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 53
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K051806.
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
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
K041202 · W.H.P.M., Inc. · Aug 2004
POLYMEDCO OC LIGHT FOBT TEST
K041297 · Polymedco, Inc. · Aug 2004
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · Roche Diagnostics Corp. · Nov 2003