Cleared Traditional

K911075 - COLOSCREEN

K911075 is the FDA 510(k) clearance for COLOSCREEN by Helena Laboratories. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K911075 · Helena Laboratories · Hematology device
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Jul 1991
Decision
114d
Days
Class 2
Risk

K911075 is an FDA 510(k) clearance for the COLOSCREEN. 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 July 3, 1991 after a review of 114 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 Helena Laboratories devices

Submission Details

510(k) Number K911075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date July 03, 1991
Days to Decision 114 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 113d · This submission: 114d
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 27
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K911075.
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998
FLEXSURE OBT
K961062 · Smithkline Diagnostics, Inc. · Nov 1996
COLOCARE
K905798 · Helena Laboratories · Jul 1991
HELENA COLOCARE
K882799 · Helena Laboratories · Sep 1988
HEMOCCULT SENSITIVE TEST
K880499 · Smithkline Diagnostics, Inc. · May 1988
WAKO(TM) PRETEST 6A
K873409 · Wako Chemicals USA, Inc. · Feb 1988