Cleared Dual Track

K173496 - Sofia 2 Lyme FIA

K173496 is the FDA 510(k) clearance for Sofia 2 Lyme FIA by Quidel Corporation. It is a Class 2 Microbiology device (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)
Optimized for regulatory review, auditing and printing
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

Submission Details

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

Device Classification

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 50
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K173496.
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191240 · Zeus Scientific, Inc. · Jul 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191398 · Zeus Scientific, Inc. · Jul 2019
BioPlex 2200 Lyme Total
K183446 · Bio-Rad Laboratories · Mar 2019
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K180264 · Gold Standard Diagnostics · May 2018
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
K173691 · Quidel Corporation · Feb 2018
Sofia Lyme FIA, Sofia Lyme Control Set
K163713 · Quidel Corporation · Oct 2017