Cleared Traditional

K905798 - COLOCARE

K905798 is an FDA 510(k) clearance for COLOCARE, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K905798 · Helena Laboratories · Hematology device
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Jul 1991
Decision
226d
Days
Class 2
Risk

K905798 is an FDA 510(k) clearance for the COLOCARE. 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 226 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.

View all Helena Laboratories devices

FDA 510(k) Submission Details - K905798

510(k) Number K905798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1990
Decision Date July 03, 1991
Days to Decision 226 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
113d slower than avg
Panel avg: 113d · This submission: 226d
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 53
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K905798.
FLEXSURE OBT
K961062 · Smithkline Diagnostics, Inc. · Nov 1996
PROPPER SUPER SERACULT(R)
K921798 · Propper Mfg. Co., Inc. · Oct 1992
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
K912979 · Labeltape Meditect, Inc. · Oct 1991
COLOSCREEN
K911075 · Helena Laboratories · Jul 1991
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
K896474 · Labsystems, Inc. · Jan 1990
HEMAWIPE SYSTEM, THE CIVILIZED TEST
K884206 · Labeltape Meditect, Inc. · Apr 1989