Cleared Traditional

COLOSCREEN-ES (K003359) - FDA 510(k) Clearance

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

K003359 · Helena Laboratories · Hematology device
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Nov 2000
Decision
31d
Days
Class 2
Risk

K003359 is an FDA 510(k) clearance for the COLOSCREEN-ES. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on November 27, 2000 after a review of 31 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Helena Laboratories devices

Submission Details

510(k) Number K003359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2000
Decision Date November 27, 2000
Days to Decision 31 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
82d faster than avg
Panel avg: 113d · This submission: 31d
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 K003359.
Instant-view-PLUS immunochemical Fecal Occult Blood Test
K173212 · Alfa Scientific Designs, Inc. · Feb 2018
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · Guangzhou Wondfo Biotech Co., Ltd. · May 2017
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · Roche Diagnostics Corp. · Nov 2003
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998
COLOCARE
K905798 · Helena Laboratories · Jul 1991