Cleared Special

K060930 - INSURE II

K060930 is an FDA 510(k) clearance for INSURE II, manufactured by Enterix, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Special 510(k) pathway after a 29-day FDA review.

K060930 · Enterix, Inc. · Hematology device
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May 2006
Decision
29d
Days
Class 2
Risk

K060930 is an FDA 510(k) clearance for the INSURE II. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Enterix, Inc. (Edison, US). The FDA issued a Cleared decision on May 4, 2006 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K060930

510(k) Number K060930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2006
Decision Date May 04, 2006
Days to Decision 29 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K060930.
OCCULTECH FECAL OCCULT BLOOD RAPID TEST
K060953 · Yd Diagnostics Corp. · Sep 2006
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
K061065 · Teco Diagnostics · Jul 2006
HEMA SCREEN SPECIFIC IFOBT
K060463 · Immunostics Inc., · Jun 2006
IMMOCARE
K052598 · Care Diagnostic, Inc. · Mar 2006
CARE FECAL OCCULT BLOOD TEST, MODEL KT313
K051806 · Epitope Diagnostics, Inc. · Oct 2005
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
K041202 · W.H.P.M., Inc. · Aug 2004
K060930 · INSURE II
Download PDF Enterix, Inc.