Cleared Traditional

K163713 - Sofia Lyme FIA, Sofia Lyme Control Set

K163713 is an FDA 510(k) clearance for Sofia Lyme FIA, manufactured by Quidel Corporation. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K163713

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.

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 K163713.
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
K173691 · Quidel Corporation · Feb 2018
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
K172722 · Euroimmun Us, Inc. · Dec 2017
Lyme B. burgdorferi (IgM) MarStripe Test
K172254 · Trinity Biotech · Oct 2017
Borrelia B31 ViraChip IgM Test Kit
K163695 · Viramed Biotech AG · Aug 2017
Borrelia B31 ViraChip IgG Test Kit
K163504 · Viramed Biotech AG · Jul 2017
Lyme B. burgdorferi (IgG) MarStripe Test
K163095 · Trinity Biotech · Feb 2017