Cleared Traditional

K002756 - EASE-A-CULT

K002756 is an FDA 510(k) clearance for EASE-A-CULT, manufactured by Diagnostica, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K002756 · Diagnostica, Inc. · Hematology device
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Feb 2001
Decision
171d
Days
Class 2
Risk

K002756 is an FDA 510(k) clearance for the EASE-A-CULT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Diagnostica, Inc. (Crofton, US). The FDA issued a Cleared decision on February 23, 2001 after a review of 171 days - an extended review cycle.

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 - K002756

510(k) Number K002756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2000
Decision Date February 23, 2001
Days to Decision 171 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
58d slower than avg
Panel avg: 113d · This submission: 171d
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 K002756.
COLONCARE
K030216 · Care Products, Inc. · Apr 2003
LIFEGUARD
K022755 · Medtek, LLC · Sep 2002
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423 · Alfa Scientific Designs, Inc. · Jun 2002
INSTACCULT
K002930 · Medtek Diagnostics, LLC · Jan 2001
!NSURE FECAL OCCULT BLOOD TEST
K002457 · Enterix, Inc. · Jan 2001
COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000
K002756 · EASE-A-CULT
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