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510(k) K141338

LIAT STREP A ASSAY by Iquum, Inc. — Product Code PGX

K141338 is an FDA 510(k) premarket notification submitted by Iquum, Inc. for the device "LIAT STREP A ASSAY". The FDA issued a decision of Substantially Equivalent on November 4, 2014. 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. Iquum, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2014
Date Received
May 21, 2014
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 Iquum, Inc.

  • K153544 — cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System (July 25, 2016)
  • K111387 — LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER (August 4, 2011)

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)
  • 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)

FDA data resources