Cleared Traditional

COLOSCREEN V.P.I. (K832864) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 96
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K832864.
Instant-view-PLUS immunochemical Fecal Occult Blood Test
K173212 · Alfa Scientific Designs, Inc. · Feb 2018
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · Guangzhou Wondfo Biotech Co., Ltd. · May 2017
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · Roche Diagnostics Corp. · Nov 2003
COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998