Cleared Traditional

K080812 - HEMOCCULT ICT

K080812 is an FDA 510(k) clearance for HEMOCCULT ICT, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K080812 · Beckman Coulter, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K080812

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.

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 96
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K080812.
HEMA SCREEN ER
K102664 · Immunostics Inc., · Jan 2011
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
K100031 · Ind Diagnostic, Inc. · Jul 2010
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
K100817 · Princeton BioMeditech Corp. · Jul 2010
DBEST ONE STEP OCCULT BLOOD TEST KITS
K071242 · Ameritek USA, Inc. · Mar 2008
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE)
K073431 · Tianjin New Bay Bioresearch Co., Ltd. · Jan 2008
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · Alfa Scientific Designs, Inc. · Jun 2007
K080812 · HEMOCCULT ICT
Download PDF FDA Summary Beckman Coulter, Inc.