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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

K173653 is an FDA 510(k) premarket notification submitted by Alere Scarborough, Inc. for the device "Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit". The FDA issued a decision of Substantially Equivalent on May 2, 2018. The device falls under product code PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System), a Class II device regulated under 21 CFR 866.2680. Alere Scarborough, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Alere Scarborough, Inc.

  • DEN180014 — WOUNDCHEK Bacterial Status (December 2, 2019)
  • K190204 — ID NOW Influenza A & B 2 (March 18, 2019)
  • K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader (August 8, 2018)
  • K173932 — Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (January 26, 2018)
  • K173502 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A (December 13, 2017)
  • K171792 — Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control S (September 29, 2017)
  • K162642 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A (April 10, 2017)
  • K163266 — Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instr (December 21, 2016)
  • K161375 — Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit (August 18, 2016)
  • K161364 — BinaxNOW G6PD Test (June 17, 2016)

Other clearances for product code PGX

  • K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (June 15, 2026)
  • K201269 — Accula Strep A Test (November 9, 2020)
  • K183366 — GenePOC Strep A (March 6, 2019)
  • 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)

FDA data resources