Cleared Traditional

K060463 - HEMA SCREEN SPECIFIC IFOBT

K060463 is an FDA 510(k) clearance for HEMA SCREEN SPECIFIC IFOBT, manufactured by Immunostics Inc.,. 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.

K060463 · Immunostics Inc., · Hematology device
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Jun 2006
Decision
104d
Days
Class 2
Risk

K060463 is an FDA 510(k) clearance for the HEMA SCREEN SPECIFIC IFOBT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on June 6, 2006 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 Immunostics Inc., devices

FDA 510(k) Submission Details - K060463

510(k) Number K060463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2006
Decision Date June 06, 2006
Days to Decision 104 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
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 37
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K060463.
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
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423 · Alfa Scientific Designs, Inc. · Jun 2002
COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000