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510(k) K183366

GenePOC Strep A by Genepoc, Inc. — Product Code PGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2019
Date Received
December 4, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Device Class
Class II
Regulation Number
866.2680
Review Panel
MI
Submission Type

An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.

Other clearances by Genepoc, Inc.

  • K190275 — GenePOC Carba (May 10, 2019)
  • K172569 — GenePOC CDiff (November 22, 2017)
  • K170558 — revogene (May 25, 2017)
  • K170557 — GenePOC GBS LB (May 25, 2017)

Other clearances for product code PGX

  • K201269 — Accula Strep A Test (November 9, 2020)
  • K173653 — Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (May 2, 2018)
  • K173398 — Xpert Xpress Strep A (April 26, 2018)
  • K172402 — ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit (October 30, 2017)
  • K172126 — Xpert Xpress Strep A (September 25, 2017)
  • K162274 — Solana Strep Complete Assay (October 25, 2016)
  • K150868 — Solana GAS Assay, Solana instrument (June 23, 2015)
  • K141757 — ALERE I STREP A (March 31, 2015)
  • K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (March 18, 2015)
  • K141338 — LIAT STREP A ASSAY (November 4, 2014)