Cleared Traditional

K832864 - COLOSCREEN V.P.I.

K832864 is an FDA 510(k) clearance for COLOSCREEN V.P.I., manufactured by Helena Laboratories. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K832864

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
15d faster than avg
Panel avg: 105d · This submission: 90d
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 Immunology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 54
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K832864.
EARLY DETECTOR
K833369 · Warner-Lambert Co. · Aug 1984
PROPPER SERACULT
K834297 · Propper Mfg. Co., Inc. · Jan 1984
HELENA BIO STRIP OB
K834456 · Helena Laboratories · Jan 1984
GASTROCCULT TM
K821884 · Smithkline Diagnostics, Inc. · Oct 1982
FE-CULT PLUS
K820072 · Gamma Biologicals, Inc. · Mar 1982
SERACULT OCCULT BLOOF TEST
K813204 · Propper Mfg. Co., Inc. · Jan 1982