Cleared Traditional

K162274 - Solana Strep Complete Assay

K162274 is the FDA 510(k) clearance for Solana Strep Complete Assay by Quidel Corporation. It is a Class 2 Microbiology device (product code PGX) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K162274 · Quidel Corporation · Microbiology device
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Oct 2016
Decision
74d
Days
Class 2
Risk

K162274 is an FDA 510(k) clearance for the Solana Strep Complete Assay. Classified as Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (product code PGX), Class II - Special Controls.

Submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on October 25, 2016 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2680 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quidel Corporation devices

Submission Details

510(k) Number K162274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2016
Decision Date October 25, 2016
Days to Decision 74 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
28d faster than avg
Panel avg: 102d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGX Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2680
Definition An In Vitro Diagnostic Test For The Detection Of Group A, C And G Beta Hemolytic Streptococcus In Throat Swab Specimens From Symptomatic Patients.
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 - PGX Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System

All 8
Devices cleared under the same product code (PGX) and FDA review panel - the closest regulatory comparables to K162274.
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
K173653 · Alere Scarborough, Inc. · May 2018
Xpert Xpress Strep A
K173398 · Cepheid · Apr 2018
Xpert Xpress Strep A
K172126 · Cepheid · Sep 2017
Solana GAS Assay, Solana instrument
K150868 · Quidel Corporation · Jun 2015
AMPLIVUE GAS ASSAY
K141173 · Quidel Corporation · Jul 2014
LYRA DIRECT STREP ASSAY
DEN140005 · Quidel Corporation · Apr 2014