Cleared Traditional

K002457 - !NSURE FECAL OCCULT BLOOD TEST

K002457 is an FDA 510(k) clearance for !NSURE FECAL OCCULT BLOOD TEST, manufactured by Enterix, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K002457 · Enterix, Inc. · Hematology device
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Jan 2001
Decision
155d
Days
Class 2
Risk

K002457 is an FDA 510(k) clearance for the !NSURE FECAL OCCULT BLOOD TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Enterix, Inc. (Falmouth,, US). The FDA issued a Cleared decision on January 12, 2001 after a review of 155 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 Enterix, Inc. devices

FDA 510(k) Submission Details - K002457

510(k) Number K002457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2000
Decision Date January 12, 2001
Days to Decision 155 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 113d · This submission: 155d
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 K002457.
POLYMEDCO OC LIGHT FOBT TEST
K041297 · Polymedco, Inc. · Aug 2004
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · Roche Diagnostics Corp. · Nov 2003
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423 · Alfa Scientific Designs, Inc. · Jun 2002
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