Cleared Traditional

K100015 - VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 (FDA 510(k) Clearance)

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

K100015 · Abbott Molecular, Inc. · Pathology device
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Aug 2011
Decision
582d
Days
Class 2
Risk

K100015 is an FDA 510(k) clearance for the VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AN.... Classified as Chronic Lymphocytic Leukemia Fish Probe Kit (product code OVQ), Class II - Special Controls.

Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on August 9, 2011 after a review of 582 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6040 - 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: 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 Pathology submissions.

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Submission Details

510(k) Number K100015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2010
Decision Date August 09, 2011
Days to Decision 582 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
505d slower than avg
Panel avg: 77d · This submission: 582d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVQ Chronic Lymphocytic Leukemia Fish Probe Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6040
Definition The Cll Fish Probe Kit Is Intended To Detect Deletion Of The Lsi Tp53, Lsi Atm, And Lsi D13s319 Probe Targets And Gain Of The D12z3 Sequence In Peripheral Blood Specimens From Untreated Patients With B-cell Chronic Lymphocytic Leukemia (cll). The Assay May Be Used To Dichotomize Cll (the 13q-, +12, Or Normal Genotype Group Versus The 11q- Or 17p- Group) And May Be Used As An Aid In Determining Disease Prognosis In Combination With Additional Biomarkers, Morphology And Other Clinical Information.
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.