Cleared Traditional

OC-SENSOR DIANA IFOB TEST (K092330) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K092330 · Polymedco Cancer Diagnostics, LLC · Hematology device
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Jan 2010
Decision
157d
Days
Class 2
Risk

K092330 is an FDA 510(k) clearance for the OC-SENSOR DIANA IFOB TEST. Classified as Automated Occult Blood Analyzer (product code OOX), Class II - Special Controls.

Submitted by Polymedco Cancer Diagnostics, LLC (Cortlandt Manor, US). The FDA issued a Cleared decision on January 8, 2010 after a review of 157 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.

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Submission Details

510(k) Number K092330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date January 08, 2010
Days to Decision 157 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 113d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code OOX Automated Occult Blood Analyzer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
Definition The Automated Test System Is Intended For The Qualitative Detection Of Fecal Occult Blood In Feces By Professional Laboratories. The Automated Test Is Used For The Determination Of Gastrointestinal Bleeding.
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.