Cleared Traditional

K141173 - AMPLIVUE GAS ASSAY

K141173 is an FDA 510(k) clearance for AMPLIVUE GAS ASSAY, manufactured by Quidel Corporation. The device is a Class 2 Microbiology device with product code PGX cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K141173 · Quidel Corporation · Microbiology device
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Jul 2014
Decision
79d
Days
Class 2
Risk

K141173 is an FDA 510(k) clearance for the AMPLIVUE GAS 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 July 24, 2014 after a review of 79 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

FDA 510(k) Submission Details - K141173

510(k) Number K141173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2014
Decision Date July 24, 2014
Days to Decision 79 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
23d faster than avg
Panel avg: 102d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGX Device Classification - Class 2, Special Controls

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 14
Devices cleared under the same product code (PGX) and FDA review panel - the closest regulatory comparables to K141173.
ALERE I STREP A
K141757 · Alere Scarborough, Inc. · Mar 2015
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
K143651 · Focus Diagnostics, Inc. · Mar 2015
LIAT STREP A ASSAY
K141338 · Iquum, Inc. · Nov 2014
LYRA DIRECT STREP ASSAY
DEN140005 · Quidel Corporation · Apr 2014