Cleared Traditional

K882799 - HELENA COLOCARE

K882799 is an FDA 510(k) clearance for HELENA 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 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

FDA 510(k) Submission Details - K882799

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.

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 K882799.
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
K896474 · Labsystems, Inc. · Jan 1990
HEMAWIPE SYSTEM, THE CIVILIZED TEST
K884206 · Labeltape Meditect, Inc. · Apr 1989
IMMUNOCCULT-LXI
K883432 · Intl. Immunoassay Laboratories, Inc. · Oct 1988
IMMUNOCCULT EIA TEST KIT
K871143 · Intl. Immunoassay Laboratories, Inc. · Jul 1988
HEMOCCULT SENSITIVE TEST
K880499 · Smithkline Diagnostics, Inc. · May 1988
WAKO(TM) PRETEST 6A
K873409 · Wako Chemicals USA, Inc. · Feb 1988