Cleared Traditional

K091960 - VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 (FDA 510(k) Clearance)

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

K091960 · Abbott Molecular, Inc. · Pathology device
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Aug 2011
Decision
789d
Days
Class 2
Risk

K091960 is an FDA 510(k) clearance for the VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPEC.... Classified as Early Growth Response 1 (egr) Fish Probe Kit (product code OWK), Class II - Special Controls.

Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on August 29, 2011 after a review of 789 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 K091960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2009
Decision Date August 29, 2011
Days to Decision 789 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
712d slower than avg
Panel avg: 77d · This submission: 789d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWK Early Growth Response 1 (egr) Fish Probe Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6040
Definition The Egr1 Fish Probe Kit Is Intended To Detect Deletion Of The Lsi Egr1 Probe Target In Bone Marrow Specimens And May Be Used, In Addition To Cytogenetics, Other Biomarkers, Morphology, And Other Clinical Information, At The Time Of Diagnosis As An Aid In Determining The Prognosis Of Acute Myeloid Leukemia (aml) Patients.
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.