Cleared Abbreviated

K021423 - INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST

K021423 is an FDA 510(k) clearance for INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST, manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Abbreviated 510(k) pathway after a 45-day FDA review.

K021423 · Alfa Scientific Designs, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Jun 2002
Decision
45d
Days
Class 2
Risk

K021423 is an FDA 510(k) clearance for the INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on June 17, 2002 after a review of 45 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Alfa Scientific Designs, Inc. devices

FDA 510(k) Submission Details - K021423

510(k) Number K021423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2002
Decision Date June 17, 2002
Days to Decision 45 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 113d · This submission: 45d
Pathway characteristics
Standards-based clearance path.

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 K021423.
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
K041202 · W.H.P.M., Inc. · Aug 2004
POLYMEDCO OC LIGHT FOBT TEST
K041297 · Polymedco, Inc. · Aug 2004
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · Roche Diagnostics Corp. · Nov 2003
COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000
COLON ALERT TEST
K992759 · Immunostics Inc., · Dec 1999
DBEST OCCULT BLOOD TEST KIT
K984269 · Ameritek, Inc. · May 1999