Cleared Traditional

K896474 - RESUBMITTED FECATWIN SENSITIVE - FECA-EIA

K896474 is an FDA 510(k) clearance for RESUBMITTED FECATWIN SENSITIVE - FECA-EIA, manufactured by Labsystems, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K896474 · Labsystems, Inc. · Hematology device
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Jan 1990
Decision
73d
Days
Class 2
Risk

K896474 is an FDA 510(k) clearance for the RESUBMITTED FECATWIN SENSITIVE - FECA-EIA. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Labsystems, Inc. (Finland, FI). The FDA issued a Cleared decision on January 25, 1990 after a review of 73 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 Labsystems, Inc. devices

FDA 510(k) Submission Details - K896474

510(k) Number K896474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1989
Decision Date January 25, 1990
Days to Decision 73 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
40d faster than avg
Panel avg: 113d · This submission: 73d
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 58
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K896474.
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
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COLOCARE
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COLOSCREEN
K911075 · Helena Laboratories · Jul 1991
HEMAWIPE SYSTEM, THE CIVILIZED TEST
K884206 · Labeltape Meditect, Inc. · Apr 1989
IMMUNOCCULT-LXI
K883432 · Intl. Immunoassay Laboratories, Inc. · Oct 1988
HELENA COLOCARE
K882799 · Helena Laboratories · Sep 1988