Cleared Traditional

K100817 - BIOSIGN IFOBTEST

K100817 is an FDA 510(k) clearance for BIOSIGN IFOBTEST, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K100817 · Princeton BioMeditech Corp. · Hematology device
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Jul 2010
Decision
104d
Days
Class 2
Risk

K100817 is an FDA 510(k) clearance for the BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on July 1, 2010 after a review of 104 days - within the typical 510(k) review window.

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 Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K100817

510(k) Number K100817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2010
Decision Date July 01, 2010
Days to Decision 104 days
Submission Type Traditional
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
9d faster than avg
Panel avg: 113d · This submission: 104d
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 36
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K100817.
Instant-view-PLUS immunochemical Fecal Occult Blood Test
K173212 · Alfa Scientific Designs, Inc. · Feb 2018
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · Guangzhou Wondfo Biotech Co., Ltd. · May 2017
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · Alfa Scientific Designs, Inc. · Jun 2007
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
K061065 · Teco Diagnostics · Jul 2006
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · Roche Diagnostics Corp. · Nov 2003