Cleared Traditional

K100817 - BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 66
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K100817.
FOB ONE STEP RAPID TEST
K110309 · Orient Gene Biotech · Sep 2011
HEMA SCREEN ER
K102664 · Immunostics Inc., · Jan 2011
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
K100031 · Ind Diagnostic, Inc. · Jul 2010
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
DBEST ONE STEP OCCULT BLOOD TEST KITS
K071242 · Ameritek USA, Inc. · Mar 2008
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE)
K073431 · Tianjin New Bay Bioresearch Co., Ltd. · Jan 2008