Cleared Traditional

K840903 - HELENA COLOSCREEN SELF-TEST

K840903 is an FDA 510(k) clearance for HELENA COLOSCREEN SELF-TEST, 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 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

FDA 510(k) Submission Details - K840903

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.

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 K840903.
BIOTEL (TM)/ KIDNEY
K855237 · American Diagnostic Corp. · May 1986
UROPAPER EIKEN 8
K843532 · Syn-Kit, Inc. · Dec 1984
COLOSCREEN SELF-TEST
K843352 · Helena Laboratories · Dec 1984
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