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510(k) K182467

Simplexa GBS Direct, Simplexa GBS Positive Control Pack by Diasorin Molecular, LLC — Product Code NJR

K182467 is an FDA 510(k) premarket notification submitted by Diasorin Molecular, LLC for the device "Simplexa GBS Direct, Simplexa GBS Positive Control Pack". The FDA issued a decision of Substantially Equivalent on November 7, 2018. The device falls under product code NJR (Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test), a Class I device regulated under 21 CFR 866.3740. Diasorin Molecular, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2018
Date Received
September 10, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.

Other clearances by Diasorin Molecular, LLC

  • K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (June 15, 2026)
  • K251978 — LIAISON NES FLU A/B, RSV & COVID-19 (December 23, 2025)
  • K252387 — Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B (October 30, 2025)
  • DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. a (July 15, 2024)
  • K220963 — Simplexa COVID-19 & Flu A/B Direct (March 17, 2023)
  • K202755 — Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack (November 5, 2022)
  • K212147 — Simplexa COVID-19 Direct (September 13, 2022)
  • K201505 — Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pa (August 22, 2020)
  • K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack (November 26, 2019)
  • K190219 — Simplexa VZV Direct, Simplexa VZV Positive Control Pack (May 13, 2019)

Other clearances for product code NJR

  • K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (September 27, 2023)
  • K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (May 9, 2022)
  • K181156 — Panther Fusion GBS Assay (July 27, 2018)
  • K173725 — NeuMoDx GBS Assay (June 26, 2018)
  • K173250 — Solana GBS Assay (December 21, 2017)
  • K170557 — GenePOC GBS LB (May 25, 2017)
  • K162772 — ARIES GBS Assay (December 23, 2016)
  • K143312 — Portrait GBS Assay (April 21, 2015)
  • K133503 — AMPLIVUE GBS ASSAY (December 20, 2013)
  • K121539 — XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GE (November 2, 2012)

FDA data resources