Cleared Traditional

K162451 - Solana HSV 1+2/VZV Assay (FDA 510(k) Clearance)

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

K162451 · Quidel Corporation · Microbiology device
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Nov 2016
Decision
88d
Days
Class 2
Risk

K162451 is an FDA 510(k) clearance for the Solana HSV 1+2/VZV Assay. Classified as Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (product code PGI), Class II - Special Controls.

Submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on November 28, 2016 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3309 - 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 Quidel Corporation devices

Submission Details

510(k) Number K162451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2016
Decision Date November 28, 2016
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGI Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3309
Definition For The Qualitative Detection And Differentiation Of Vzv, Hsv1, Hsv2- Dna In Cutaneous And Mucocutaneous Lesion Samples From Symptomatic Patients. The Assay Is Not Intended For Use With Cerebral Spinal Fluid.
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.

Regulatory Peers - PGI Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

All 8
Devices cleared under the same product code (PGI) and FDA review panel - the closest regulatory comparables to K162451.
Alinity m HSV 1 & 2 / VZV
K233349 · Abbott Molecular, Inc. · May 2024
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
K232286 · Quidel Corporation · Dec 2023
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
K192376 · Diasorin Molecular, LLC · Nov 2019