Not Cleared Post-NSE

DEN130010 - VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) (FDA 510(k) Clearance)

Class II Pathology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN130010 · Abbott Molecular, Inc. · Pathology device
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Jul 2013
Decision
111d
Days
Class 2
Risk

DEN130010 is an FDA 510(k) submission (not cleared) for the VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION). Classified as Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization (product code PDO), Class II - Special Controls.

Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Not Cleared (DENG) decision on July 29, 2013 after a review of 111 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Pathology review framework.

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Submission Details

510(k) Number DEN130010 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 09, 2013
Decision Date July 29, 2013
Days to Decision 111 days
Submission Type Post-NSE
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 77d · This submission: 111d
Pathway characteristics

Device Classification

Product Code PDO Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1870
Definition The Egr1 Fish Probe Kit For Specimen Characterization Detects The Lsi Egr1 Probe Target On Chromosome 5q In Bone Marrow Specimens. This Assay Is Used To Characterize Bone Marrow Specimens From Patients With Acute Myeloid Leukemia (aml) Or Myelodysplastic Syndrome. The Assay Results Are To Be Interpreted By A Qualified Pathologist Or Cytogeneticist.
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.