Cleared Traditional

HEMOCCULT ICT (K080812) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080812 · Beckman Coulter, Inc. · Hematology device
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Jun 2008
Decision
93d
Days
Class 2
Risk

K080812 is an FDA 510(k) clearance for the HEMOCCULT ICT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on June 25, 2008 after a review of 93 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K080812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2008
Decision Date June 25, 2008
Days to Decision 93 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
20d faster than avg
Panel avg: 113d · This submission: 93d
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 96
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K080812.
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Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · Guangzhou Wondfo Biotech Co., Ltd. · May 2017
COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000
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COLOSCREEN
K911075 · Helena Laboratories · Jul 1991