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PGX — Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System Class II

FDA Device Classification

Classification Details

Product Code
PGX
Device Class
Class II
Regulation Number
866.2680
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K173398cepheidXpert Xpress Strep AApril 26, 2018
K172402luminex corporationARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitOctober 30, 2017
K172126cepheidXpert Xpress Strep ASeptember 25, 2017
K162274quidel corporationSolana Strep Complete AssayOctober 25, 2016
K150868quidel corporationSolana GAS Assay, Solana instrumentJune 23, 2015
K141757alere scarboroughALERE I STREP AMarch 31, 2015
K143651focus diagnosticsSimplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackMarch 18, 2015
K141338iquumLIAT STREP A ASSAYNovember 4, 2014
K141173quidel corporationAMPLIVUE GAS ASSAYJuly 24, 2014
DEN140005quidel corporationLYRA DIRECT STREP ASSAYApril 16, 2014