Cleared Traditional

K954214 - CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT (FDA 510(k) Clearance)

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

K954214 · Vysis · Pathology device
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Jan 1997
Decision
502d
Days
Class 2
Risk

K954214 is an FDA 510(k) clearance for the CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT. Classified as Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment (product code OXP), Class II - Special Controls.

Submitted by Vysis (Downers Grove, US). The FDA issued a Cleared decision on January 21, 1997 after a review of 502 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6010 - 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 K954214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1995
Decision Date January 21, 1997
Days to Decision 502 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
425d slower than avg
Panel avg: 77d · This submission: 502d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OXP Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
Definition X/y Dna Probe Kit Is Intended To Detect Alpha Satellite Sequences In The Centromere Of Chromosome (chr) X And Satellite Iii Dna At Yq12 Of Chr Y Along With Routine Diagnostic Cytogenetic Testing. It Is Indicated For Use As An Adjunct To Standard Cytogenetic Analysis For Identifying And Enumerating Chr X And Y Via Fish In Interphase Nuclei And Metaphase Spreads Obtained From Bone Marrow (bm) Specimens In Recipients Of Opposite-sex Bm Transplantation (bmt) For Hematological Disorders. It Is Not Intended To Be Used As A Stand Alone Assay For Test Reporting; In Subjects With Like-sex Bmt; In Diagnostic Testing Or Screening For Constitutional X And Y Chr Aneuploidies.
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.