Cleared Traditional

K832864 - COLOSCREEN V.P.I.

K832864 is the FDA 510(k) clearance for COLOSCREEN V.P.I. by Helena Laboratories. It is a Class 2 Immunology device (product code KHE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K832864 · Helena Laboratories · Immunology device
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Nov 1983
Decision
90d
Days
Class 2
Risk

K832864 is an FDA 510(k) clearance for the COLOSCREEN V.P.I.. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.6550 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

Submission Details

510(k) Number K832864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1983
Decision Date November 21, 1983
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 104d · This submission: 90d
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 Immunology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 28
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K832864.
HELENA COLOSCREEN SELF-TEST
K840903 · Helena Laboratories · Aug 1984
EARLY DETECTOR
K833369 · Warner-Lambert Co. · Aug 1984
HELENA BIO STRIP OB
K834456 · Helena Laboratories · Jan 1984
GASTROCCULT TM
K821884 · Smithkline Diagnostics, Inc. · Oct 1982
HELENA COLOSCREEN METHOD
K812428 · Helena Laboratories · Oct 1981
HELENA COLOCHECK
K800433 · Helena Laboratories · May 1980