Cleared Traditional

K812428 - HELENA COLOSCREEN METHOD

K812428 is an FDA 510(k) clearance for HELENA COLOSCREEN METHOD, 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 59-day FDA review.

K812428 · Helena Laboratories · Hematology device
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Oct 1981
Decision
59d
Days
Class 2
Risk

K812428 is an FDA 510(k) clearance for the HELENA COLOSCREEN METHOD. 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 October 23, 1981 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Helena Laboratories devices

FDA 510(k) Submission Details - K812428

510(k) Number K812428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1981
Decision Date October 23, 1981
Days to Decision 59 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
54d faster than avg
Panel avg: 113d · This submission: 59d
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 54
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K812428.
SERACULT OCCULT BLOOF TEST
K813204 · Propper Mfg. Co., Inc. · Jan 1982
UROPAPER EIKEG
K811815 · Syn-Kit, Inc. · Dec 1981
FE-CULT PLUS
K811752 · Gamma Biologicals, Inc. · Nov 1981
HELENA COLOCHECK
K800433 · Helena Laboratories · May 1980
HELENA COLOSCREEN
K792655 · Helena Laboratories · Jan 1980
HEMO FEC
K780214 · Boehringer Mannheim Corp. · May 1978