Cleared Traditional

K163713 - Sofia Lyme FIA

K163713 is the FDA 510(k) clearance for Sofia Lyme FIA by Quidel Corporation. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K163713 · Quidel Corporation · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
294d
Days
Class 2
Risk

K163713 is an FDA 510(k) clearance for the Sofia 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 October 20, 2017 after a review of 294 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 K163713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2016
Decision Date October 20, 2017
Days to Decision 294 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
192d slower than avg
Panel avg: 102d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K163713.
Sofia 2 Lyme FIA, Sofia Lyme Control Set
K173496 · Quidel Corporation · Aug 2018
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
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
K113397 · Zeus Scientific, Inc. · Jul 2012
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
K100728 · Zeus Scientific, Inc. · Jul 2010
PLATELIA LYME IGM
K081362 · Bio-Rad · Jun 2008