Cleared Special

IND ONE STEP OCCULT BLOOD (FOB) TEST (K113506) - FDA 510(k) Clearance

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K113506 · Ind Diagnostics, Inc. · Hematology device
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Dec 2012
Decision
387d
Days
Class 2
Risk

K113506 is an FDA 510(k) clearance for the IND ONE STEP OCCULT BLOOD (FOB) TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Ind Diagnostics, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on December 19, 2012 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ind Diagnostics, Inc. devices

Submission Details

510(k) Number K113506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2011
Decision Date December 19, 2012
Days to Decision 387 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
274d slower than avg
Panel avg: 113d · This submission: 387d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.