Cleared Traditional

CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (K951821) - FDA 510(k) Clearance

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

K951821 · Light Diagnostics · Microbiology device
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Jun 1996
Decision
414d
Days
Class 2
Risk

K951821 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY. Classified as Antisera, Conjugated Fluorescent, Cytomegalovirus (product code LIN), Class II - Special Controls.

Submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on June 7, 1996 after a review of 414 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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: 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 Microbiology submissions.

View all Light Diagnostics devices

Submission Details

510(k) Number K951821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1995
Decision Date June 07, 1996
Days to Decision 414 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
312d slower than avg
Panel avg: 102d · This submission: 414d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
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 Microbiology devices follow this clearance model.