Cleared Traditional

K153538 - Dextramer CMV Kit (FDA 510(k) Clearance)

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

K153538 · Immudex Aps · Immunology device
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Mar 2017
Decision
448d
Days
Class 2
Risk

K153538 is an FDA 510(k) clearance for the Dextramer CMV Kit. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Immudex Aps (Copenhagen/Kobenhavn, DK). The FDA issued a Cleared decision on March 2, 2017 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.5220 - the FDA immunology 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 Immunology submissions.

View all Immudex Aps devices

Submission Details

510(k) Number K153538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2015
Decision Date March 02, 2017
Days to Decision 448 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
344d slower than avg
Panel avg: 104d · This submission: 448d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 Immunology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

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