Cleared Traditional

K882799 - HELENA COLOCARE

K882799 is the FDA 510(k) clearance for HELENA COLOCARE by Helena Laboratories. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K882799 · Helena Laboratories · Hematology device
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Sep 1988
Decision
86d
Days
Class 2
Risk

K882799 is an FDA 510(k) clearance for the HELENA 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 September 30, 1988 after a review of 86 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 K882799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1988
Decision Date September 30, 1988
Days to Decision 86 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
27d faster than avg
Panel avg: 113d · This submission: 86d
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 K882799.
FLEXSURE OBT
K961062 · Smithkline Diagnostics, Inc. · Nov 1996
COLOCARE
K905798 · Helena Laboratories · Jul 1991
COLOSCREEN
K911075 · Helena Laboratories · Jul 1991
HEMOCCULT SENSITIVE TEST
K880499 · Smithkline Diagnostics, Inc. · May 1988
WAKO(TM) PRETEST 6A
K873409 · Wako Chemicals USA, Inc. · Feb 1988
HEMOCCULT WIPE TEST
K862849 · Smithkline Diagnostics, Inc. · Dec 1986