Cleared Traditional

K840903 - HELENA COLOSCREEN SELF-TEST

K840903 is the FDA 510(k) clearance for HELENA COLOSCREEN SELF-TEST by Helena Laboratories. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K840903 · Helena Laboratories · Hematology device
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Aug 1984
Decision
164d
Days
Class 2
Risk

K840903 is an FDA 510(k) clearance for the HELENA COLOSCREEN SELF-TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Helena Laboratories (Walker, US). The FDA issued a Cleared decision on August 10, 1984 after a review of 164 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

Submission Details

510(k) Number K840903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1984
Decision Date August 10, 1984
Days to Decision 164 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
51d slower than avg
Panel avg: 113d · This submission: 164d
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 K840903.
HEMOCCULT WIPE TEST
K862849 · Smithkline Diagnostics, Inc. · Dec 1986
BIOTEL (TM)/ KIDNEY
K855237 · American Diagnostic Corp. · May 1986
COLOSCREEN SELF-TEST
K843352 · Helena Laboratories · Dec 1984
EARLY DETECTOR
K833369 · Warner-Lambert Co. · Aug 1984
HELENA BIO STRIP OB
K834456 · Helena Laboratories · Jan 1984
COLOSCREEN V.P.I.
K832864 · Helena Laboratories · Nov 1983