Cleared Traditional

K211342 - Sofia 2 Campylobacter FIA (FDA 510(k) Clearance)

Class I Microbiology device.

K211342 · Quidel Corporation · Microbiology device
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Nov 2021
Decision
204d
Days
Class 1
Risk

K211342 is an FDA 510(k) clearance for the Sofia 2 Campylobacter FIA. Classified as Campylobacter Spp. (product code LQP), Class I - General Controls.

Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on November 23, 2021 after a review of 204 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K211342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2021
Decision Date November 23, 2021
Days to Decision 204 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 102d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQP 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.