Cleared Traditional

K962873 - CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE (FDA 510(k) Clearance)

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

K962873 · Vysis · Pathology device
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Jan 1997
Decision
174d
Days
Class 2
Risk

K962873 is an FDA 510(k) clearance for the CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE. Classified as Chronic Lymphocytic Leukemia Fish Probe Kit (product code OVQ), Class II - Special Controls.

Submitted by Vysis (Downers Grove, US). The FDA issued a Cleared decision on January 13, 1997 after a review of 174 days - an extended review cycle.

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: 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 K962873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1996
Decision Date January 13, 1997
Days to Decision 174 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
97d slower than avg
Panel avg: 77d · This submission: 174d
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.