Cleared Traditional

K901064 - MONOHAEM (FECAL OCCULT BLOOD TEST)

K901064 is an FDA 510(k) clearance for MONOHAEM (FECAL OCCULT BLOOD TEST), manufactured by Silenus Laboratories Proprietary , Ltd.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K901064 · Silenus Laboratories Proprietary , Ltd. · Hematology device
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Nov 1990
Decision
243d
Days
Class 2
Risk

K901064 is an FDA 510(k) clearance for the MONOHAEM (FECAL OCCULT BLOOD TEST). Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Silenus Laboratories Proprietary , Ltd. (Wilmington, US). The FDA issued a Cleared decision on November 5, 1990 after a review of 243 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 Silenus Laboratories Proprietary , Ltd. devices

FDA 510(k) Submission Details - K901064

510(k) Number K901064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date November 05, 1990
Days to Decision 243 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 113d · This submission: 243d
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 62
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K901064.
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
K912979 · Labeltape Meditect, Inc. · Oct 1991
COLOCARE
K905798 · Helena Laboratories · Jul 1991
COLOSCREEN
K911075 · Helena Laboratories · Jul 1991
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
K896474 · Labsystems, Inc. · Jan 1990
HEMAWIPE SYSTEM, THE CIVILIZED TEST
K884206 · Labeltape Meditect, Inc. · Apr 1989
IMMUNOCCULT-LXI
K883432 · Intl. Immunoassay Laboratories, Inc. · Oct 1988