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510(k) K173653

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit by Alere Scarborough, Inc. — Product Code PGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2018
Date Received
November 28, 2017
Clearance Type
Dual Track
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.

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  • K161375 — Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit (August 18, 2016)
  • K161364 — BinaxNOW G6PD Test (June 17, 2016)

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  • 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)