Home / 510(k) Clearances / K060540

510(k) K060540

XPERT, GENEXPERT DX SYSTEM by Cepheid — Product Code NJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2006
Date Received
March 1, 2006
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 Cepheid

  • K253653 — Xpert Hemorrhagic Fever (February 20, 2026)
  • K251721 — Xpert GI Panel (January 16, 2026)
  • K250218 — Xpert® FII & FV (February 21, 2025)
  • K242071 — Xpert Xpress CoV-2/Flu/RSV plus (January 10, 2025)
  • DEN240016 — Xpert HCV; GeneXpert Xpress System (June 27, 2024)
  • K231381 — Xpert Xpress MVP; GeneXpert Xpress System (October 19, 2023)
  • K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (September 27, 2023)
  • K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (June 7, 2022)
  • K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (May 9, 2022)
  • K212213 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (February 9, 2022)

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)
  • K182467 — Simplexa GBS Direct, Simplexa GBS Positive Control Pack (November 7, 2018)
  • 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)