Cleared Traditional

VIROGEN CMV ANTIBODY TEST (K875101) - FDA 510(k) Clearance

Class I Microbiology device.

K875101 · Wampole Laboratories · Microbiology device
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Mar 1988
Decision
82d
Days
Class 1
Risk

K875101 is an FDA 510(k) clearance for the VIROGEN CMV ANTIBODY TEST. Classified as Dna-reagents, Campylobacter Spp. (product code LQO), Class I - General Controls.

Submitted by Wampole Laboratories (Cranbury, US). The FDA issued a Cleared decision on March 1, 1988 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wampole Laboratories devices

Submission Details

510(k) Number K875101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1987
Decision Date March 01, 1988
Days to Decision 82 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 102d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQO Dna-reagents, Campylobacter Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.