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510(k) K143651

Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack by Focus Diagnostics, Inc. — Product Code PGX

K143651 is an FDA 510(k) premarket notification submitted by Focus Diagnostics, Inc. for the device "Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack". The FDA issued a decision of Substantially Equivalent on March 18, 2015. 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. Focus Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2015
Date Received
December 23, 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 Focus Diagnostics, Inc.

  • K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (September 21, 2015)
  • K150962 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (August 28, 2015)
  • K142365 — Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (December 5, 2014)
  • K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (July 1, 2014)
  • DEN130049 — SIMPLEXA HSV 1&2 DIRECT (March 21, 2014)
  • K120986 — STRATIFY JCV DXSELECT (August 16, 2012)
  • K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (July 13, 2012)
  • K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (April 4, 2012)
  • DEN120008 — STRATIFY JCV(TM) ANTIBODY (January 20, 2012)
  • K102170 — SIMPLEXA FLU A/B & RSV (November 24, 2010)

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