Cleared Traditional

K131508 - VYSIS D7S486/CEP 7 FISH PROBE KIT (FDA 510(k) Clearance)

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

K131508 · Abbott Molecular, Inc. · Pathology device
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Sep 2013
Decision
112d
Days
Class 2
Risk

K131508 is an FDA 510(k) clearance for the VYSIS D7S486/CEP 7 FISH PROBE KIT. Classified as Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders (product code PFG), Class II - Special Controls.

Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on September 13, 2013 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1870 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K131508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2013
Decision Date September 13, 2013
Days to Decision 112 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 77d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PFG Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1870
Definition Dna Fish Probe Kits For Specimen Characterization Detect Dna Probe Targets On Human Chromosomes In Bone Marrow And Peripheral Blood Specimens.
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 Pathology devices follow this clearance model.