Cleared Dual Track

K173496 - Sofia 2 Lyme FIA, Sofia Lyme Control Set

K173496 is an FDA 510(k) clearance for Sofia 2 Lyme FIA, manufactured by Quidel Corporation. The device is a Class 2 Microbiology device with product code LSR cleared through the Dual Track 510(k) pathway after a 290-day FDA review.

K173496 · Quidel Corporation · Microbiology device
Download Printable Device Report (PDF)
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Aug 2018
Decision
290d
Days
Class 2
Risk

K173496 is an FDA 510(k) clearance for the Sofia 2 Lyme FIA, Sofia Lyme Control Set. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Quidel Corporation (San Diego,, US). The FDA issued a Cleared decision on August 30, 2018 after a review of 290 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - 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.

View all Quidel Corporation devices

FDA 510(k) Submission Details - K173496

510(k) Number K173496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2017
Decision Date August 30, 2018
Days to Decision 290 days
Submission Type Dual Track
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
188d slower than avg
Panel avg: 102d · This submission: 290d
Pathway characteristics

LSR Device Classification - Class 2, Special Controls

Product Code LSR Reagent, Borrelia Serological Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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 - LSR Reagent, Borrelia Serological Reagent

All 97
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K173496.
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