Cleared Traditional

VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY (K101234) - FDA 510(k) Clearance

Class I Microbiology device.

K101234 · Ventana Medical Systems, Inc. · Microbiology device
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Aug 2011
Decision
479d
Days
Class 1
Risk

K101234 is an FDA 510(k) clearance for the VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY. Classified as Immunohistochemical Assay, Helicobacter Pylori (product code OWF), Class I - General Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on August 25, 2011 after a review of 479 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Ventana Medical Systems, Inc. devices

Submission Details

510(k) Number K101234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2010
Decision Date August 25, 2011
Days to Decision 479 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
377d slower than avg
Panel avg: 102d · This submission: 479d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OWF Immunohistochemical Assay, Helicobacter Pylori
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
Definition Anti-helicobacter Pylori Rabbit Monoclonal Primary Antibody Is Designed To Qualitatively Detect The Presence Of Helicobacter Pylori In Formalin-fixed, Paraffin-embedded Gastric Biopsy Tissue Via Light Microscopy. Immunohistochemical Staining With This Antibody Product May Aid In The Diagnosis Of Helicobacter Pylori Infection. This Product Should Be Interpreted By A Qualified Pathologist In Conjunction With Histological Examination, Relevant Clinical Information And Proper Controls. This Antibody Is Intended For In Vitro Diagnostic (ivd) Use
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.