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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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 96
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K021423.
HEMAPROMPT GASTRIC
K031356 · Aerscher Diagnostics · Sep 2003
COLONCARE
K030216 · Care Products, Inc. · Apr 2003
LIFEGUARD
K022755 · Medtek, LLC · Sep 2002
EASE-A-CULT
K002756 · Diagnostica, Inc. · Feb 2001
INSTACCULT
K002930 · Medtek Diagnostics, LLC · Jan 2001
!NSURE FECAL OCCULT BLOOD TEST
K002457 · Enterix, Inc. · Jan 2001
K021423 · INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
Download PDF FDA Summary Alfa Scientific Desig…