Cleared Traditional

K100031 - IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10

K100031 is an FDA 510(k) clearance for IND ONE STEP FECAL OCCULT BLOOD TEST MO..., manufactured by Ind Diagnostic, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K100031 · Ind Diagnostic, Inc. · Hematology device
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Jul 2010
Decision
194d
Days
Class 2
Risk

K100031 is an FDA 510(k) clearance for the IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Ind Diagnostic, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on July 19, 2010 after a review of 194 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 Ind Diagnostic, Inc. devices

FDA 510(k) Submission Details - K100031

510(k) Number K100031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2010
Decision Date July 19, 2010
Days to Decision 194 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 113d · This submission: 194d
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 K100031.
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
K121397 · SEKISUI Diagnostics, LLC · Dec 2012
IND ONE STEP OCCULT BLOOD (FOB) TEST
K113506 · Ind Diagnostics, Inc. · Dec 2012
FOB ONE STEP RAPID TEST
K110309 · Orient Gene Biotech · Sep 2011
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
K100817 · Princeton BioMeditech Corp. · Jul 2010
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · Alfa Scientific Designs, Inc. · Jun 2007